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New Drugs Approved by CDSCO

Sr.No

Drug Name

Strength

Indication

Date of Approval

Eslicarbazepine Acetate Tablets 200mg/400mg/600mg/800mg

Each uncoated tablet contains; eslicarbazepine acetate-200mg, 400mg, 600mg, 800mg

As an adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.

07.03.11

2-Sulphanilamide-5-methyl pyrimidine

0.5 g tablets

Sulpha drug

1970- January

2-thymyloxy methyl Glyoxalidine Hcl

Each 100 ml contains; 2-thymyl-oxy-methyl glyoxalidine hydrochloride-0.05, buffered aq. Sol. Vehicle q.s

1971- January

Acetylcystein

Antimycolytic enzyme.

1966- March

Amylobarbitone & Trifluoperazine dihydrochloride

Psychoneurotics, tranquilizer & sedative.

1967- February

Atenolol bulk

1986-January

Azacitidine for injection 100 mg/vial

Each vial contains; azacitidine-100mg

For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome.

29.04.14

Bromonaphthol

250 mg tabs

Anthelmintic-in hookwarm infection only.

1963- February

Cefprozil Powder for oral suspension (125mg/5ml)

Antibiotic.

06/01/2006

Centbucridine (0.5%) + Feracrylem (3%)

For hemorrhoid & anal fissure

11-01-2005

Cephradine

i)-Each capsule contains; cephradine-250mg & 500mg, ii)-Each vial contains; Cephradine -250mg, 500mg &1gm, iii)-Each 5mL suspension contains; Cephradine-250mg

Antibiotic- indicated in the treatment of infection of G.I., genito-utrinary, respiratory tract and soft tissue.

1976-March

Cinnarizine + Domperidone tablets

Each tablet contains; cinnarizine-20mg, domperidone-15mg

Prevention of symptoms caused by vestibular disorders and vertigo/motion sickness, nausea, dizziness, headache, vomiting, sensation of fullness, when there is a delay in gastric emptying.

1992- February

Ciprofloxacin eye drops/eye oitment

Ciprofloxacin-0.3% w/v

Indicated in the treatment of external ocular infection of the eye.

1991- February

Cyanocobalamine + Zinc Tannic acid

500 mcg every 2 week

Same as vit. B12, but it has rapid onset of action and provides prolonged effect for a month or more.

1961 January

Cyproheptadine

Each tablet contains; cyproheptadine Hcl-4mg

1973-January

Degarelix for Injection 80mg / 120mg per vial

Each pack contains; 1. One vial containing; degarelix (as acetate) 80mg, 120mg 2. One solvent vial of water for injection 6ml 3.One syringe 4. One reconstitution needle & one injection needle.

For the treatment of adult patients with advanced hormone dependent prostate cancer.

19.01.12

Deoxyribonuclease

Vials of 250000 & 100000 units

An enzyme preparation obtained in a crystalline form from bovine pancrease indicated in the treatment of localised abscess in mammary infection.

1968- January

Dimethindene maleate

Anti-histaminic

1965- January

Disprospan injection

Each vial contains; betamethasone dipropionate-6.43mg, betamethasone sodium phosphate-2.63mg

1984-July

Dobutamine hcl in 5% dextrose inj.

Each 250ml contains; dobutamine hcl eq.to dobutamine-250mg, 500mg, 1000mg

RMP-Short treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures.

05/01/2001

Domperidone SR tab

Each uncoated SR tab contains; domperidone BP-30mg

For the treatment of chronic dyspepsia, gastro paresis, nausea & vomiting.

16-01-2003

Enrofloxacin 5% oral solution & 10% inj.

i)-Each ml of inj.contains; enrofloxacin-100mg,50mg, ii)-Each ml of oral solution contains; enrofloxacin-50mg,100mg

10/01/1994

Fenbendazole bulk drug

1983-january

Flavoxate Hydrochloride

Each tablet contains; Flavoxate Hydrochloride-100mg

1981

Fluprednylidene-21-Acetate

Each 100gm contains; Fluprednylidene-21-Acetate-0.1gm

1978

Glimepiride

Each tablet contains; glimepiride 1mg/2mg/3mg/4mg

Adjunct to diet or exercise to lower the blood glucose in patients with non insulin dependent(type-II) diabetes mellitus whose hyperglycemia cannot be controlled by diet and single agent alone.

24/01/1999

Lofepramine tablet

Each tablet contains; lofepramine-35mg,70mg

Tricyclic anti depressants- Indicated in the treatment of depressive condition only.

1990- January

Lurasidone Hydrochloride Tablet 40mg/80mh & Bulk

Each film coated tablet contains; Lurasidone Hydrochloride 40mg, 80mh

For the treatment of patients with Schizophrenia.

04.01.17

Me-salicylate 30% + Menthol 10% + camphor 4% Cream

For temporary relief from pain, swelling & inflammation due to musculoskeletal disorder.

29.11.07

Metaraminol bitartarate

2-10mg im/sc, 0.5-5mg iv

Sympathomimetic (adrenergic) urgent vasopressor.

1964- January

Nateglinide + Metformin (SR) tablets

Each film coated tablet contains; nateglinide-60mg,120mg, metformin hcl (SR)-500mg

RMP- in patients with type-II diabetes inadequately controlled by diet, exercise and maximally tolerated dose of metformin alone.

08/01/2004

Nimesulide tablets

i)-Each tablet contains; nimesulide-100mg, ii)-Each 5ml suspension contains; nimesulide-50mg(17-5-96), iii)-Nimesulide transdermal gel-1% (7-6-96), iv)-Suppositories-50mg, 100mg (17-5-99)

Inflammatory condition including joint disorders such as rheumatoid arthritis, post traumatic and post operative painful condition and fever.

13/01/1995

Nintedanib soft Gelatin Capsule 100/150mg

Each soft gelatin capsule contains; nintedanib ethanesulfonate eq.to nintedanib-100mg, 150mg

For the treatment of Idiopathic Pulmonary Fibrosis (IPF).

11.03.16

Nitroglycerin oitnment

Anti-anginal drug- Indicated in treatment of angina pectoris due to coronary artery disease.

1982-january

Norfloxacin powder 10%

Each gm contains; norfloxacin USP-100mg

Wide variety of infections caused by susceptible gram +ve and gram -ve organism including mixed infection in poultry.

12/03/1997

Oxiconazole nitrate

Oxiconazole nitrate-1% w/v

For topical treatment of superficial fungal infections of the skin

17-01-2000

Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml

For infections of the respiratory system in secondary and primary immunodeficiency with alteration in maturation of T cells in adults only.

11.02.11

Polyvinyl alcohol + Povidone + Chlorbutanol eye drops

Each ml contains; polyvinyl alcohol-14mg, povidone-6mg, chlorbutanol-5mg

For relief from burning, irritation and discomfort due to dryness of the eye.

11/01/1996

Practolol

Each tablet contains; Practolol BP-100mg

1974

Propranolol + Hydrallazine

Each tablet contains; Propranolol-40mg, Hydrallazine-25mg

1980-February

Prothipendyl hydrochloride

40-120 mg/day

Psycho sedative & Tranquiliser-relaxes the autonomas system.

1962- January

Reserpine + clopamide + dihydroergocristine

Each tablet contains; Reserpine-0.1mg, clopamide-5mg, dihydroergocristine-0.5mg

1972- January

Rivaroxaban Tablet

Each film coated tablet contains; rivaroxaban-10mg

For the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

03.02.10

R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection

Chemotherapy induced nausea & vomiting.

12.01.07

Ruxolitinib Tablet 5mg/15mg/20mg

Each tablet contains; ruxolitinib-5mg, 15mg, 20mg

For the treatment of patients with myelofibrosis including primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

28.01.13

Selamectin Tropical solution (for verterinary use) 60mg/120mg per ml

salamectin-60mg, 120mg

(I) For the treatement and lasting prevention of flea infestations,treatment and control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs and cats. (II) For the treatement and prevention of sarcoptÞ¡

14.01.09

Sofosbuvir Tablet 400mg

Each film coated tablet contains; sofosbuvir-400mg

In combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

13.01.15

Sulphadiazine + Trimethoprim tablets/suspension

Each tablet contains; sulphadiazine-400mg, trimethoprim-80mg, Each 5ml suspension contains; sulphadiazine-200mg, trimethoprim-40mg

1987-January

Tolfenamic acid cap

Cap. 200mg

Additional indication of migraine

07/01/2002

Tolnaftate

1% sol. In bottle of 10 cc

Treatment of dermatomycosis.

1969- January

Tolnaftate + Nystatin

Each gm contains; Tolnaftate-10mg, Nystatin-100,000 Units

1977-February

Tramadol hydrochloride injection

Each capsule contains; tramadol-50mg,100mg, Each 1ml ampoule contains; tramadol hcl-50mg, Each 2ml ampoule contains; tramadol hcl-100mg

Analgesic- Severe acute and chronic pain, diagnostic measures and surgical pain.

27/01/1993

Tramadol SR

Moderate to severe pain.

27/01/1998

Trimethoprim + Sulphamethoxozole

Each 3mL ampoule contains; Trimethoprim-160mg, Sulphamethoxozole-800mg

1979-January

Trinovum (triphasic oral contraceptive)

Each pill contains; 0.5mg norethindrone + 35mcg ethinyloestradiol, Each pill contains; 0.75mg norethindrone + 35mcg ethinyloestradiol, Each pill contains; 1mg norethindrone + 35mcg ethinyloestradiol.

1988-January

Tripotassium dicitrato bismuthate chewable tablets/suspension

Chewable tablet-each contains; 120mg of tripotassium dicitrato bismuthate calculated as bismuth, Suspension-each 5ml contains; 120mg as TDB calculated as bismuth.

Anti ulcer- Indicated in the treatment of gastric & duodenal ulcers.

1989-January

Trofodermin cream

Each 100gm contains; clostebol-500mg, neomycin sulphate-500mg

1985-June

Zoalene + Ethoxyquin

Zoalene-25%, Ethoxyquin-0.125%

1975- January

Acetyl salicylic acid + Aluminium Hydrochloride + Magnesium Hydrocloride

Each tablet contains; Acetyl salicylic acid-350mg, Aluminium Hydrochloride-90mg, Magnesium Hydrocloride-90mg

1981-November

Alphachymotrypsin

Each tablet contains; Alphachymotrypsin- 25chg units

1975-July

Epi-Growth Factor 1gm + Silversulphadiazine Cream

For Burns.

19.10.2004

Amino acid 5% (w/v) IV infusion with & without electrolytes

5% w/v

For parenteral nutrition in patients with protein depletion condition.

07/02/2001

Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg Tablet (Additional Strength)

For the treatment of mild to moderate Hypertension.

02.01.13

Aripiprazole tablets

Each uncoated tablet contains; aripiprazole-5mg

Psychiatrist only- for the treatment of schizophrenia.

23/02/2004

Armodafinil uncoated tablet ..50/150/250mg

Each uncoated tablet contains; armodafinil-50mg, 150mg, 250mg

To improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy.

23.04.10

Bimatoprost Opthalmic solution 0.03%

For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

30.03.09

Bismuth aluminate

New bismuth salt (antacid).

1962- April

Bisoprolol fumerate 2:1 + hydrochlorthiazide

Bisoprolol fumerate (2:1)-2.5mg,5mg, hydrochlorthiazide-6.25mg

Mild to moderate hypertension.

13-05-1999

Brinzolamide Ophthalmic Suspension 1%w/v

Each ml contains; brinzolamide-10mg

For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

26.05.11

Canagliflozin, 100 & 300 mg Tablet

Each film coated tablet contains; canagliflozin-100mg, 300mg

â??Indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type-2 Diabetic Mellitusâ?.

17.11.14

Ceftriaxone sodium injection

Each vial contains; ceftriaxone sodium eq.to 250mg,500mg,1gm of ceftriaxone base.

Cephalosporin antibiotic- Indicated in the treatment of UTI, lower respiratory tract infections, bacteraemia, septicaemia, meningitis, abdominal infections and infections caused by pseudomonas species.

1988-April

Chloramphenicol

Each capsule contains; chloramphenicol-500 mg

1972- October

Chlordantoin + Benzylkonium chloride

Each 100gm contains; Chlordantoin-1%, Benzylkonium chloride-0.05%

Anti-fungal agent

1970- August

Clenbuterol Hydrochloride Solution for injection 30mcg/ml

For the treatment of equine respiratory diseases in horses where airway obstruction due to bronchospasm and/or accumulation of mucus is contributing factor and improved muco-ciliary clearance is desirable. The product should be used alone or as an adjuvanÞ¡

01.07.2012

Clozapine tablets

Each uncoated tablet contains; clozapine-25mg, 100mg.

Indicated in the management of schzophrenic patients.

07/03/1995

Cyclandelate

Each capsule contains; Cyclandelate-200mg

1977-July

Desloratadine tabs.

Each tablets 5mg desloratadine

For additional indication; chronic idiopathic urticaria

14-01-2002

Dexchlorpheniramine maleate

Each tablet contains; Dexchlorpheniramine maleate-2mg

1976-July

Diltiazem inj.

Each ml contains; diltiazem hcl-5mg

16/05/1994

d-norgestrel + ethinyloestradiol

Each tablet contains; d-norgestrel 0.25mg, ethinyloestradiol-0.05mg

1971- April

Etomidate injection

Each ml contains; etomidate-2mg

Anaesthetic agent- induction of general anaesthesia and for maintenance of short duration anaesthesia for surgical procedures.

1985-August

Fluocortolone caproate + Fluocortolon Trimethyl acetate

Each 100gm contain s;Fluocortolone caproate-0.25gm, Fluocortolon Trimethyl acetate-0.25gm

1978-June

Glipizide + Metformin tablets

Each tab contains; glipizide-2.5mg,5mg, metformin-250mg,500mg

For non insulin dependent diabetes mellitus.

20/03/1998

Gonadorelin (6-D-Phe) 0.05mg/ml solution for injection (Veterinary)

Each ml contains; 0.05mg gonadorelin (6-D-Phe) eq.to 0.0524mg gonadorelin (6-D-Phe) acetae.

Control and induction prodecude in cattle and pig reproduction. Therapy of ovarian infertility disorders or dysfunctions of the reproductive organs in cattle and horses.

15.06.16

Gugulipid

Lipid lowering agent

1986-June

Gugulipid tablets

Each tablet contains; gugulipid eq.to guggulsterone-25mg

1987-March

Lynestrenol + Ethinyloestradiol

22 active tablets, each contains; Lynestrenol-1mg, Ethinyloestradiol-50mg, 6 Placebo tablets contain Ferrus Fumerate-60mg

1980-June

Mebhydroline Napadisylate

50mg tabs

Antihistaminic

1964- February

Mepartricin tablet

Each enteric coated tablet contains; mepatricin-50000units

Functional disorders in benign prostatic hypertrophy.

28/05/1993

Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet

For acute painful musculoskeletal condition in adult.

22/02/2005

Miconazole Nitrate

Miconazole Nitrate-2%

1979-March

Mitoxantrone bulk drug

1989-March

Nalbuphine injection 10mg/20mg per ml.

Eacl ml contains; nalbuphine HCl-10mg, 20mg

For the relief of moderate to severe pain.

08.02.07

Norethisterone acetate and ethinyl oestradiol

1 mg (20 tabs)

Oral contraceptive

1967- April

Norgestrel + Ethinyloestradiol

Oral contraceptive

1968- August

Olanzapine + fluoxetine tab

Each film coated tab contains; olanzapine-5mg,10mg, floxetine hcl eq.to fluoxetine-20mg

For treatment of resistant depression only.

18-02-2003

Oral (rehydration salts) tabs

Each tab contains; NaCl-0.125gm, KCl-0.150gm, NaHCO3-0.250gm, Citric acid (anhd.)-0.577gm, Dextrose (anhd.)-2.650gm

22/04/1996

Orciprenaline sulphate

Sympathomimetic

1965- April

Pefloxacin mesylate dihydrate

i)-Each film coated tablet contains; pefloxacin methane sulphonate dihydrate eq.to-400mg pefloxacin, ii)-Each 5ml ampoule contains (injection i.v); pefloxacin methane sulphonate dihydrate eq.to-400mg pefloxacin, iii)-Each 100ml/200ml bottle contains (i.v)Þ¡

Antibacterial- In the treatment of severe infection in adults caused by sensitive microorganism (gram -ve pathogens and staphylococci).

1991- May

100

Pegaptinib Sodium Injection (0.3mg)

For neovascular (wet) age related macular degeneration.

06/02/2006

101

Piroxicam gel

Piroxicam gel-0.5%

In the treament of musculo-skeletal inflammatory disorders.

1990- March

102

Pyridoxine hcl CR tablet

Each C.R tablet contains; pyridoxine hcl-100mg.

Deficiency of vit.B6 caused by usage of oral contraceptive pill/drug induced pyridoxine deficiency.

07/05/1992

103

Recombinant human erythropoietin

For addition indication of autologous blood donation in case of anaemia due to chronic renal failure and anemia associated with cancer.

07/02/2000

104

Resperidone tabs

i)-Each film coated tablet contains; resperidone-1mg,2mg,3mg,4mg ii)-resperidone liquid-each ml contains;resperidone-1mg (14.5.97)

Acute and chronic schizophrenic psychosis and other psychotic conditions in which +ve symptoms and -ve symptoms are prominent.

03/04/1997

105

Sodium and maglumine iothalamate

Meglumine iothalamate 52% w/v, sodium iothalamate 26% w/w

Contrast medium

1969- July

106

Sodium polyhydroxy aluminium monocarbonate hexitol complex

360 mg tabs

Antacid.

1963- May

107

Spiranolactone

100 mg, 4 times a day.

Promotes diuresis in patients with oedema or ascites, resistant or patly resistant to convetional diuretics.

1961- March

108

Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet

For the treatment of adult patients with HIV infection.

07.01.08

109

Terbutaline sulphate with guaiphenesin syrup

Each 5ml contains; terbutaline sulphate-1.5mg, guaiphenesin-66.5mg

1982-October

110

Tinidazole suspension

Each 5ml contains; tinidazole-75mg

1983-December

111

Trifluperidol Hcl

Oral liquid-Each 5mL contains; Trifluperidol Hcl-5mg, Injection-Each ml contains; trifluperidol hcl-1mg, Tablet-0.25mg, 0.5mg

Neuroleptic agent.

1973-May

112

Trimethoprim + Sulphadoxime

Trimethoprim - 4% w/v, Sulphadoxine - 20% w/v

1974-July

113

Vilazodone HCl 20 mg 40 mg Tablet

Each film coated tablet contains; vilazodone hydrochloride-20mg, 40mg

For the treatment of major depressive disorders in adults.

19.08.15

114

Ceftiofur hcl liquid sterile suspension

Each ml suspension contains; ceftiofur hcl eq.to ceftiofur-50mg

For treatment & control of swine & bovine bacterial respiratory diseases.

08/10/2002

115

Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each.

i) Each film coated tablet contains; quinine sulphate IP-600mg ii) Each hard gelatin capsule contains; doxycycline hydrochloride IP eq.to doxycycline-100mg

For the treatment of P. Falciparam malaria in adults.

10/08/2006

116

Duloxetine hcl enteric coated tablets

Each enteric coated tablet contains; duloxetine hcl eq.to duloxetine-20mg,30mg,40mg, 40mg capsule should be used only for once daily dosing.

By psychiatrists- for the treatment of major depressive disorders in adults only.

02/11/2004

117

Esomeprazole magnesium bulk & tab

Each enteric coated tablet contains; esomeprazole magnesium eq.to esomeprazole-20mg,40mg

GERD, erosive reflux esophagitis, prevention of relapse of esophagitis & helps in eradication of H.Pylori associated peptic ulcer.

04/12/2001

118

Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream.

For the treatment of wound of different etiology.

31.03.09

119

Imatinib mesylate 100 mg/400mg Tablets and 100mg Capsules (Additional Indication)

1. For the Treatment of Adult Patients with newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukaemia(Ph+ALL) integrated with chemotherapy 2. Treatment of Adult patients with relapsed or refractory Ph+ALL as monotherapy 3. Treatment oÞ¡

11.08.11

120

Lactitol Sachet (10gm/20gm)

Each sachet contains; lactitol monohydrate eq.to lactitol-10gm, 20gm

For the treatment of constipation.

21/11/2005

121

Mebeverine HCl prolonged release capsule (200mg)

Each SR capsule contains; mebeverine hydrochloride-200mg

For the symptomatic treatment of irritable bowel syndrome in adults.

20.06.07

122

Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets

For symptomatic treatment of acute rhinosinusitis.

28.03.08

123

Lithium carbonate

In manic depression.

1969- August

124

Pantoprazole Mouth Dissolving Tablet 20/40 mg

For the treatment of gastric ulcer, duodenal ulcer & gastroesophageal reflux disease (GERD).

30.03.10

125

Aspirin Bolus (Vet.) 6gm/bolus)

For Veterinary use.

21/11/2005

126

Cilnidipine Tabs. 5mg, 10mg

Each tablet contains; cilnidipine-5mg, 10mg

For the treatment of mild to moderate hypertension.

21.06.2007

127

Deflazocort tablets

Each tablet contains; deflazocort-1mg,6mg,30mg

By specialists only- for the treatment of asthma, rheumatoid arthritis when glucocorticosteroid therapy is warranted.

02/11/2004

128

Dexketoprofen (as Trometamol) tablets 12.5mg/25mg

For the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain.

28.03.08

129

Fosphenytoin sod. Inj.

Each 2ml & 10ml vial contains; fosphenytoin sod. 75mg/ml eq.to phenytoin sod. 50mg/ml

Generalized convulsive status epilepticus, prevention & treatment of seizures occurring during neurosurgery & head injury when other means of phenytoin administration are unavailable, inappropriate or less advantageous.

01/10/2002

130

Pravastatin 40mg tablet (Additional strength)

Each tab contains; Pravastatin sod. phEur. 40mg

As an adjunct to diet to reduce elevated total cholesterol, LDL-C, Apo-B TG levels and to increase HDL-C in patients with primary hypercholesterolaemia and mixed dyslipidaemia.

09/08/2006

131

Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets

For the treatment of mixed infections with roundworms and tapeworms in dogs.

30.03.10

132

Rifaximin Tablet 550 mg (Additional strength and Additional Indication)

For Reduction in Risk of Overt Hepatic Encephalopathy (HE) Recurrence in Patients â?¥ 18 years of Age.

18.08.11

133

Ropinirole hcl bulk & tab

Each film coated tablet contains; ropinirole hcl eq.to ropinirole-0.25mg, 0.5mg, 1mg, 2mg, 5mg

Monotherapy or as an adjunct to levodopa in idiopathic parkinsons' disease.

03/12/2001

134

Telmisartan 80mg + Amlodipine 5mg tablet

Additional higher strength.

31.03.09

135

Azithromycin 500mg + Ambroxol S.R (75mg) Tablet

For RTI caused by susceptible organisms in adults.

05.07.2007

136

Combipack of omeprazole + clarithromycin + amoxycillin

Each combipack contains; omeprazole cap-20mgÃ?2, clarithromycin tab-500mgÃ?2, amoxycillin cap-500mgÃ?4

For eradication of H.pylori in patients with active chronic gastritis, gastric ulcer & duodenal ulcer.

01/10/2002

137

Dexamethasone tablets

Each uncoated tablet contains; dexamethasone IP-4mg,8mg

Oncologists only- for steroid responsive neoplastic disease like leukemias and lymphomas in adults only.

02/11/2004

138

Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet

For dyspepsia, colic pain & GERD.

22/11/2005

139

Etanercept (recombinant) powder for inj.along with diluent & syringe

Each vial contains; Etanercept-25mg

Reduction of signs & symptoms of moderate to severe active rheumatoid arthritis in patients who have had an inadequate response to one or more disease modifying antirheumatic drugs

07/12/2001

140

Hyaluronic Acid Sodium Salt (i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad containsHyaluronic Acid Sodium Salt 50/100mg

For the treatment of wound of different etiology.

31.03.09

141

Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule

For the treatment of Gastrooesophageal Reflux Disease (GERD)

19.08.11

142

Nepafenac Opthalmic suspension (1mg/ml)

For the treatment of pain and inflammation associated with cataract surgery.

31.03.08

143

Olanzapine powder For oral suspension (10mg/5ml) & sachet (5mg/gm)

i) Each 5ml of recon.suspension contains; olanzapine-10mg, ii) Each sachet contains; olanzapine-5mg/gm

For the treatment of schizophrenia in adult patients having difficulty in swallowing.

11/08/2006

144

Tolperisone Hcl SR 450mg Tablets

For the relief of painful muscle spasms of the skeletal muscualture.

30.03.10

145

Abatacept Injection 250mg/vial (additional indication)

For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARD's such as MTXÞ¡

10.04.09

146

Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj.

Each vial contains; amikacin sulphate I.P eq.to amikacin-0.125gm, 0.250gm, Cefepime hydrochloride eq.to cefepime-0.5gm, 1.0gm

For the treatment of pneumonia, bacterial septicaemia, respiratory, abdominal, urinary & skin infection.

11/08/2006

147

Each Combikit contains Part A - One film coated tablet of Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg

For the treatment of HIV infection in adults.

23.08.11

148

Hylan GF 20 Injection (Synvisc) (Additional Indication)

For pain management in patients suffering with osteoarthritis of the knee, hip, shoulder and ankle.

31.03.08

149

Metaxolone tab & bulk

Each tab contains; metaxolone-400mg

As an adjunct to rest, physical therapy & other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.

08/10/2002

150

Methylphenidate Hcl E.R Tablet

Each extended release contains; methylphenidate Hcl USP-18mg, 36mg, 54mg.

By psychiatrists-for the treatment of attention deficit hyperactivity disorders (ADHD)

08/12/2004

151

Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops

For Ophthalmic use.

24/11/2005

152

Acotiamide Hydrochloride Bulk & Tablet 100mg

Each film coated tablet contains; acotiamide hydrochloride hydrate-100mg

For the treatment of bloating after meals, epigastric bloating and early satiety in functional dyspepsia.

06.07.16

153

N.Meningitides Gr. C Conjugate vaccine

Each 0.5ml dose contains; meningococcal Gr.C polysaccharide conjugated with 10-20mcg of T.T protein, adsorbed to 0.5mg aluminium.

Active immunization of children from two months of age, adolescents & adults for the prevention of invasive disease caused by N.meningitides serogroup C.

19/12/2001

154

Pholcodine Syrup (4mg/5ml)

Each 5ml contains; pholcodine-4mg

For symptomatic relief of dry, ticklish and unproductive coughs in children above 1 years.

10.07.07

155

S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets

For the treatment of patients with both essential hypertension and hypercholesterolemia.

01.04.10

156

Atomoxetine hcl capsules

Each hard gelatin capsule contains; atomoxetine hcl eq.to atomoxetine-10mg,18mg,25mg,40mg.

By psychiatrist- for the treatment of attention deficit hyperactivity disorders. -Patients requiring long term therapy should be monitored & consideration should be given to interrupting therapy in patients who are not growing or gaining weight satisfactoÞ¡

09/11/2004

157

Atorvastatin 10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules

For secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate.

05.04.10

158

Cetrizine 10 mg + Ambroxol 75 mg SR Tablet

For symptomatic relief of productive cough associated with allergic rhinitis, when both antihistamine and mucolytic agents are desired.

13.04.09

159

Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules

For the treatment of patient with acute musculoskeletal spasm associated with low back pain.

24.08.11

160

Docetaxel injection conc.

For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer".

31.03.08

161

Exenatide Injection -pre-filled pen (250mcg/ml)

Each pre-filled pen contains; exenatide-250mcg/ml

For adjunctive therapy to improve glycemic control in patients with Type-II diabetes mellitus, who have not achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonylurea.

09.07.07

162

Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet

Anti HIV.

11/08/2006

163

Pregabalin capsule (75/150/300 mg)

For neuropathic pain.

25/11/2005

164

S(-) amlodipine + atenolol tab

Each tab contains; S(-) amlodipine-2.5mg, atenolol-25mg,50mg

Essential hypertension & angina pectoris.

17-10-2002

165

Trimetazidine modified release tablet

Each modified release film coated tablet contains; trimetazidine Di Hcl-35mg

Ischaemic heart disease, angina pectoris, sequalaes of infarction.

03/12/2001

166

Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI

Indicated as third line treatment of severe cases of COPD, whenmonotherapy and second line therapy with two drugs do not respond adequately.

13.04.09

167

Lamotrigine 25mg Modified Release Tablet (Addl. Strength)

Same as Approved

05.04.10

168

Methotrexate Topical gel (1%) Addl.Strength

Psoriasis.

25/11/2005

169

Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D-Panthenol IP 50mg per 2 ml of injection

For peripheral neuropathy.

31.03.08

170

Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic Solution

For reduction of post-operative inflammatory conditions of the eyes.

11/07/2007

171

Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream

Each gm contains; nadifloxacin-10mg, mometasone furoate USP-1mg

For the treatment of mixed infections of the skin associated with inflammation.

17/08/2006

172

Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets

Additional Strength

24.08.11

173

S(-) amlodipine + losartan pot.tab

Each tab contains; S(-) amlodipine-2.5mg, losartan pot.-25mg,50mg, S(-)amlodipine-5mg+losartan-50mg(appr.on 17-4-02)

Mild to moderate hypertension

17-10-2002

174

Somatropin (rDNA) injection

Vials-4 IU,16 IU, Cartridges-18 IU,36 IU,72 IU

For additional indication; i)-for treatment of adult onset or childhood onset, adult growth hormone deficiency, ii)-long term treatment of idiopathic short stature also called non growth hormone deficient short stature. Shelf life increase 24 months to 36Þ¡

25/11/2004

175

Zafirlukast tab & bulk

Each film coated tablet contains; zafirlukast-10mg,20mg.

For prophylaxis & treatment of chronic asthma in adults & children over 5 year of age.

03/12/2001

176

Acyclovir 50g + Hydrocortisone 10mg Cream

For the early treatment of recurrent cold sores in adult patients to reduce likelihood of ulcerative cold sores and to shorten the lesion healing time.

30.08.11

177

Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml

Ophthalmic

25/11/2005

178

Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mg

For the tretament of patients with mild to modrate essential hypertension.

13.04.09

179

HSA free recombinant human erythropoietin injection

Each vial contains; HSA free recombinant erythropoietin injection-1000 IU, 2000 IU, 3000 IU, 4000 IU, 10000 IU

Additional strength.

07/12/2001

180

Imatinib Mesylate 100/400mg Tablets (Addl. Indication)

Adjuvant treatment of adult patients following resection of gastrointestinal stromal tumours (GIST).

05.04.10

181

Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength)

Same as Approved.

01.04.08

182

Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye drops

For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.

11/07/2007

183

Meglumine gadoterate soln.for i.v inj

Each 100ml contains; gadoteric acid-27.932gm, meglumine-9.76gm

Magnetic imaging diagnostic investigation including MR angiography.

23-10-2002

184

Metoprolol succinate ER tablets

Metoprolol succinate-25mg,50mg,100mg,200mg

Additional indication; i)-functional heart disorders, ii)-migraine prophylaxis, iii)-cardiac arrhythmias, iv)-prevention of cardiac death and reinfarction after the acute phase of myocardial infarction v)-stable symptomatic CHF

29/11/2004

185

Premetrexed(Disodium) powder For solution For Inj. 500mg/vial

Anti Cancer.

21/08/2006

186

Acamprosate calcium tabs/bulk

Each enteric coated tab contains; acamprosate calcium-333mg

As therapy to maintain abstinence unalcohol dependent patients. It should be combined with counselling.

30-10-2002

187

Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength)

Same as Approved

05.04.10

188

Clindamycin Phosphate eq. To Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel

For topical treatment of inflammatory acne vulgaris (Additional lower strength).

30.08.11

189

Combikit of stavudine + Lamivudine + Nevirapine tablets

Each kit contains; 2 tablets of (uncoated) stavudine-3mg,40mg, lamivudine-150mg, 1 tablet of nevirapine-200mg

By RMP only- for HIV infection in adults who have been stabilized on the maintenance regimen of nevirapine (200mg) B.D and have demostrated adequate tolerability to nevirapine.

22/11/2004

190

Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet

Anti- diabetic.

22/08/2006

191

Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5/1.5mg + Chromium Polynicotinate 65mcg/200mcg + Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule

For Vitamins and Mineral deficiency states in adult patients.

11/07/2007

192

Milnacipran 25/50mg Caps (Addl. Indication)

For the management of fibromylagia.

15.04.09

193

Nicardipine Hcl. Injection 2.5mg/ml

Each ml contains; nicardipine Hcl-2.5mg

For short-term treatment of hypertension when oral therapy is not feasible or not desirable.

07.04.08

194

Testosterone transdermal Spray (25mg)

Each spray delivers; testosterone-25mg

For replacement therapy in males for conditions with a deficiency or absence of endogenous testosterone.

30/11/2005

195

Valsartan bulk & cap.

Each capsule contains; valsartan-80mg, 160mg

Mild to moderate hypertension

10/12/2001

196

Cefepime hcl for inj/bulk

Each vial contains; cefepime (as hcl)-500mg,1gm,2gm

Uncomplicated and complicated UTI, umcomplicated skin and skin structure infection, lower respiratory tract infection, acute bacterial exacerbation of chronic bronchitis and acute bronchitis intra abdominal infection.

30-10-2002

197

Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength)

For the treatment of acute pain in adults.

08.04.08

198

Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication)

For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata.

05.04.10

199

Lornoxicam SR 16mg Tabs

For the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis.

25.04.09

200

Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops

For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.

12/07/2007

201

Moxifloxacin tab.

Additional indication of skin & soft tissue infection & pelvic inflammatory disease.

27/12/2001

202

Omeprazole Powder for suspension (20mg/Sachet)

Anti-ulcer

30/11/2005

203

Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops

For temporary relief of burning and irritation due to dryness of the eye.

13.09.11

204

Tiropramide Hcl (100mg) tablet

For abdominal spasmodic pain, colics of hepatobilliary track, abdominal colics.

22/08/2006

205

Ursodeoxycholic acid SR capsules

Each SR cap contains; ursodeoxycholic acid-450mg

By RMP- for the dissolution of radiolucent cholesterol gallstone, chronic cholestatic liver diseases in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cystic fibrosis.

01/12/2004

206

Clotrimazole (10mg) + Methylprednisolone aceponate 1mg/gm of cream

For fungal infection of skin associated with inflammation.

12/07/2007

207

Diacerin 50mg + Aceclofenac 100mg tablets

For the treatment of adult patients with osteoarthritis of knee and or hip joints.

11.04.08

208

Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet

For hypertension.

30/11/2005

209

Eperisone Hcl (50mg ) tablet

For neck-shoulder ormsyndrome scapula hum oral per arthritis and low back pain.

23/08/2006

210

Ibuprofen 400mg + Chlorzoxazone 500mg Tablets

For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only.

07.04.10

211

Leuprolide acetate (3 months) depot

11.25mg/vial injection

For additional indication; "advanced prostatic cancer", subject to all condition of MF 1447/04 dated 26-05-2004. 3 months depot, 11.25mg/vial, injection.

03/12/2003

212

Metformin (ER )1000mg/500mg + Saxagliptin 2.5 mg/5mg Tablets

As an Adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate.

19.09.11

213

Palonosetron Hcl 0.075mg IV Inj (Addl. Strength)

Same as approved.

25.04.09

214

Tegaserod maleate tabs

Each uncoated tab contains; tegaserod maleate eq.to tegaserod-6mg,2mg (appr.on 3-2-03)

For the treatment of constipation predominant irritable bowel syndrome (IBS) in adults.

01/11/2002

215

Topiramate sprinkle capsule

Each capsule contains; topiramate-15mg

Additional strength.

24/12/2001

216

Afatinib Tablet 20, 30, 40 mg

Each film coated tablet contains; afatinib-20mg, 30mg, 40mg, 50mg (free base) corresponding to afatinib dimaleate 29.56mg, 44.34mg, 59.12mg, 73.9mg

For â??treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutationâ?

30.12.14

217

Apixaban Tablets 2.5mg

Each film coated tablet contains; apixaban-2.5mg

Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.

03.08.2012

218

Besifloxacin Ophthalmic Suspension 0.6% w/v

Each ml contains; besifloxacin-6mg

For the treatment of bacterial conjunctivitis.

31.05.11

219

Carboplatin bulk/injection

Each vial contains; carboplatin-50mg,150mg, Mannitol IP-50mg,150mg.

Anti cancer- Advance stage of ovarian cancer, small cell carcinoma of lungs.

1989-March

220

Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet

For the treatment of Urinary tract infections, respiratory tract infections, biliary tract infections in adult patients prone to antibiotic associated diarrhoea.

07.01.08

221

Cephacetrile sodium intra mammary infusion

Each tube contains; cephacetrile sod.eq.to 235 mg of cephacetrile in 10gm of suspension.

Mastitis caused by streptococcus agalactial, str.dysgalactial, str. Uberis, str. Aureus (both penicillin-sensitive and resistant strain) gram negative bacterial including E.coli and klebsiella.

13/05/1992

222

Choline salicylate

Analgesic

1965- April

223

Ciclesonide Inhaler 80/160mcg per actuation

Each actuation delivers; ciclesonide-80mcg, 160mcg

For the treatment to control persistent asthma in adults (18 yeras & older).

06/02/2006

224

Cinnarizine tablets

Each tablet contains; cinnarizine-25mg,15mg and others

Anti histaminic- in the treatment of vestibular disturbances & vertigo only.

1985-August

225

Ciprofloxacin + ornidazole tab

Each film coated tab contains; ciprofloxacin hcl eq.to ciprofloxacin-500mg, ornidazole-500mg

For treatment of diarrhoea of mixed infection in a adult patients only.

03/02/2003

226

Cisapride + MPS chewable tablets

Management of dyspepsia due to functional causes, peptic ulcer, oral oesophagitis, prevention and therapy of reflux oesophagitis, gastroporesis, due to diabetic neuropathy, anorexia-nervosa, vagotomy, post operative causes, radiation therapy, gastritis, iÞ¡

03/05/1993

227

Ephedrine sulphate

Each capsule contains; 75 mg ephedrine sulphide in sustained release.

1971- May

228

Etidronate disodium tabs

Each tablet contains; etidronate disodium-200mg

Hypercalcemia induced by various malignant disorders.

10/03/1995

229

Etodolac caps/tabs

Each tab contains; etodolac BP-200mg,400mg, Each cap contains; etodolac-300mg

Inflammation and painful conditions in osteoarthritis, acute attacks of gout and pseudogout, pain following dental extraction, post operative and post episiotomy pain dysmenorrhoea acute musculoskeletal pain.

10/04/1997

230

Flumethasone pivalate + iodochloro hydroxyquinoline

Flumethasone pivalate-0.02%, iodochloro hydroxyquinoline-1.00%

1972- October

231

Fluoxetine hydrochloride

Each capsule contains; fluoxetine hcl-20mg (60mg cap-Intas), fluoxetine hcl syrup-20mg/5ml

For the treatment of depression.

1990- March

232

Formoterol fumarate

i)-Each cap contains; formoterol fumerate-12mcg, ii)-Each actuation delivers formoterol fumerate-12mcg (29-6-2001)

For bronchial asthma.

16-02-2000

233

Gemigliptin 50 mg tablet

Each film coated tablet contains; gemigliptin tartrate sesquihydrate (eq.to gemigliptin 50mg)-68.9mg

As an adjunct to the diet & exercise to improve to improve glycemic control in adults with type-2 diabetes mellitus, as an monotherapy or in combination with metformin in patients with inadequate glycemic control on metformin alone.

21.08.15

234

Hexadimethrine bromide

1.33mg for 100USP units of Heparin

Heparin antagonist.

1962- April

235

Ibuprofen

Each 5mL contains; Ibuprofen-100mg

1979-April

236

Indacaterol (as Maleate) Inhalation Powder Hard Capsules â?¦.. ...150/300mcg

Each capsule contains; indacaterol maleate eq.to indacaterol-150mcg, 300mcg

For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).

28.04.10

237

Indinavir sulphate

Each capsule contains; indinavir (as sulphate)-200mg, 400mg

By RMP- indicated in treatment of HIV infection in adults only in combination with anti-retroviral agents.

02/02/2001

238

Infectious coryza vaccine (Inactivated)

1987-March

239

Injection of vitamin A, D, B

Vitamin preparation.

1969- July

240

Ketoprofen

50mg

Non steroidal anti- inflammatory agent- Indicated in the treatment rheumatoid arthritis, Osteroarthritis, ankylosing spondylites, gout.

1981-April

241

Levobunolol hydrochloride ophthalmic solution

Each ml contains; levobunolol hcl USP-2.5mg,5.0mg.

For the control of intra-ocular pressure in chronic open angle glaucoma and ocular hypertension.

16/05/1996

242

Levonorgestrel 1.5mg tablets

For emergency contraceptive

07.02.07

243

Luprostiol

Each vial contains; Luprostiol-7.5mg

Prostaglandin- Indicated in the treatment of corpora lutea, induction of abortion etc.

1986-June

244

Measles mumps & rubella vaccine

1983-February

245

Minoxidil topical lotion

Each ml contains; minoxidil-20mg

Alopecia- Indicated in the treatment of male pattern baldness.

1988-May

246

Nabumetone

Nabumetone-500mg, 750mg

Osteoarthritis & rheumatoid arthritis

17-05-1999

247

Nicoumalone Tablets 0.5mg/5mg/6mg

For the prevention and treatment of thromboembolic diseases such as venous thrombosis, atrial fibrillation with embolization, pulmonary embolism and as an adjunct in the treatment of coronary occulsion.

18.01.13

248

Ofloxacin infusion

Each 50ml vial contains; ofloxacin-100mg, Each 100ml vial contains; ofloxacin-200mg

Indicated in RTI, UTI, gynaecological infection, skin/soft lesion infection.

1991- May

249

Oxcarbazepine tab

150mg,300mg,600mg

For additional indication of adjunctive therapy in the treatment of partial seizures in children in the age group of 4-14 years with epilepsy.

14-01-2002

250

Oxethazine Hcl.

5ml gel

An antacid demulcent mucosal anesthetic indicated in the treatment of chronic oesophagitis, gastritis, peptic ulcer, irritable bowel syndrome.

1967- June

251

Parbendazole + Ethoxygm + Extracted Soya flour

Parbendazole-4% w/w, Ethoxygm(100%)-0.125% w/w, Extracted Soya flour added to 100%

Treatment of Helmenthiasis

1973-June

252

Perindopril + Indapamide tabs

Each tab contains; perindopril-2mg,4mg, indapamide-0.625mg,1.25mg.

Mild to moderate essential hypertension.

24/03/1998

253

Petoxyfyline

1977-August

254

Phenprobamate

400 mg

Muscle relaxant & tranquiliser.

1964- March

255

Phenylbutazone calcium

200mg & 50 mg tabs

Anti-inflammatory, anti-rheumatic.

1963- May

256

Propranolol with hydroflumethazide tablets

Each tablet contaisn; propranolol hydrochloride-40mg, hydroflumethazide-25mg

1982-October

257

Protein derived from soya bean

Each 150gm contains; Protein derived from soya bean-33.2gm

1978-June

258

Prothionamide

Anti T.B Drug

1970- September

259

Sertraline hcl

Each film coated tablet contains; sertraline hcl eq.to sertraline-50mg,100mg

By psychiatrist only- for the treatment of i)-pre menstrual dysphoric depression, ii)-social anxiety disorders.

23/02/2004

260

Terconazole vaginal ovule/vaginal cream

i)-Each ovule contains; terconazole-80mg, ii)-Terconazole vaginal cream contains; terconazole-0.8%

For the local treatment of vulvovaginal candidiasis (moniliasis)

19/07/1994

261

Trabectedin powder for concentrate for solution for infusion

Each vial contains; trabectedin-0.25mg

For the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents.

01.04.09

262

Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet

For primary dysmenorrhoea and pain associated with menorrhagia in women.

22/02/2005

263

Tretinoin

Airal vanishing cream-Each 20gm contains; Tretinoin-0.05%, Airal lotion- Each 50mL contains; Tritinoin- 0.05%

Topical acne therapy- For the treatment of Acne vulgaris.

1974-July

264

Triethanalamine trinitrate bisphosphate

8mg to 16mg daily

Treatment of Angina pectoris. It is a vasodilator like glyceryl trinitrate.

1961- March

265

Trimetazidine Dihydrochloride

Each tablet contains; Trimetazidine Dihydrochloride-3mg

Cardiac drug, indicated in the treatment of angina pectoris and intermittant Claudication

1980-June

266

Trimipramine

10mg & 25mg tabs, injection-12.5mg/2ml

Depressive illness, severe potentially suicidal depression, neurotic and reactive depression.

1968- September

267

Trofosfamide

Each tablet contains; Trofosfamide-50mg

To cancer hospitals or institution and against prescription of cancer specialists

1976-August

268

Virginiamycin

2% premix contains; 40gm of Virginiamycin, 50% granules per kg

1975-July

269

Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl.Strength)

For hypertension.

30/11/2005

270

Capecitabin Tablet (150mg/500mg). (for additional indication)

(i). First line treatment of advanced gastric cancer in combination with platinum based regimen.(ii). Treatment of patients with locally advanced or metastatic breast cancer in combination with docetaxel following failure of cytotoxic chemotherapy.

16/07/2007

271

Caroverine cap. 20mg & Inj. 40mg/2ml

i) Each capsule contains; caroverine-20mg, ii)Each 2ml injection contains; caroverine-40mg

For the treatment of abdominal pain & tinnitus in adults only.

28/08/2006

272

Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/1000mg.injection

Additional Indication - For the treatment of urinary tract infections and lower respiratory tract infections, various bacteria.

21.09.11

273

Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets

For the treatment of bronchial asthma in adults.

07.04.10

274

Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg

Addtional strength.

25.04.09

275

Feracrylum solution 1% w/v

Each ampoule contains; feracrylum solution 1% w/v.

External haemostatic agent.

21/05/1992

276

Fentanyl citrate transmucosal tab

Each tab contains; fentanyl citrate eq.to fentanyl-200mcg,400mcg,600mcg

New delivery system-management of break through cancer pain in patients with malignancies who are already receiving & who are tolerant to opoid therapy for this underlying persisten cancer pain.

29-10-2002

277

Hylan GF 20 injection

Each ml contains; hylans-8mg

Treatment of pain in osteoarthritis of knee in patients who have failed to respond adequately to conservative non-pharmacological therapy & to simple analgesics.

20/12/2001

278

Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg)

Same as Approved.

16.04.08

279

Zoldronic acid injection

Additional indication; 4mg/vial inj. "in prevention of skeletal related events, pathological fractures, spinal compression, radiation or surgery to bone or tumour induced hypocalcaemia in patients with advanced malignancies involving bones", in ref.to earÞ¡

29/11/2004

280

Albendazole 400 mg + Ivermectin 6 mg tablet

For the treatment of intestinal helminthes and suppression of microfilaraemia especially with bancrofti infections.

25.04.09

281

Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops

For steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

22.09.11

282

Dosulepin Hcl Tablet 25mg/75mg (Additional Indication)

For the treatment of chronic pain.

08.04.10

283

FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + Hydrochlorthiazide (12.5mg/12.5mg/25mg)

For essential hypertension.

02/12/2005

284

Leflunomide (10mg/20mg/100mg)

10mg,20mg,100mg

For additional indication; "active psoriatic arthritis in adults only" subject to all condition of 4-136/04 dt. 30-08-2004.

29/11/2004

285

Live freeze-dried lactic acid bacteria and bifidobacteria capsules

For the treatment of irritable bowel syndrome.

10.04.08

286

Nitrous oxide as pre mixed gases

Homogenous gas containing 50% nitrous oxide by volume & 50% oxygen by volume compressed in a cylinder.

For relief of pain usually in emergency situation & several in vasive procedure.

20/12/2001

287

Paclitaxel nanoparticle Inj. (20mg/ml)

For metastatic breast cancer.

23/08/2006

288

Pioglitazone hcl + glimepiride tab

Each tab contains; pioglitazone hcl eq.to pioglitazone-15mg, glimepiride-1mg,2mg

Treatment of type-II diabetes as 2nd line therapy when diet exercise & initial therapy with glitazone or sulphonylurea do not result in adequate glycemic control.

25-10-2002

289

Rifabutin Capsule (150mg)

Each capsule contains; rifabutin USP-150mg

For treatment of pulmonary T.B only in patients co-infected with HIV. (It should never be used as a substitute to Rifampicin in T.B patients without HIV co-infection).

19/07/2007

290

Amoxycillin 250mg + Dicloxacillin 250mg cap.

Each capsule contains; amoxicillin trihydrate BP eq.to amoxicillin-250mg, dicloxacillin sodium BP eq.to dicloxacillin-250mg

For the treatment of RTI, UTI, otitis media, dental abscess, septicaemia, soft tissue, infections and other bacterial infections due to beta-lactamase producing organism.

28/08/2006

291

Docetaxel injection (80mg/2ml)

80mg/2ml

For additional indication; docetaxel in combination with doxorubicin & cyclophophamide as adjuvant therapy in treatment of patients with operable node positive breast cancer. Subject to all conditions of 12-6/95 dt. 21-06-96.

2004

292

Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion

For the tretament of pruritis and prickly heat.

08.05.09

293

Lapatinib (as Ditosylate) (250mg) Tablet

Each film coated tablet contains; lapatinib ditosylate eq.to lapatinib-250mg

Lapatinib In combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumour overexpress HER2+/neu and who have received prior therapy including trastuzumab.

24/07/2007

294

Miltefosin Capsule 10mg/50mg (Additional Indication)

Treatment of cutaneous leishmaniasis.

16.04.08

295

Phenylephrine 2.5% Eye drops

Ophthalmic

02/12/2005

296

Pioglitazone + metformin (OD)

Each uncoated tab contains; pioglitazone-15mg, metformin (OD)-500mg

By RMP- for second line therapy in type-II diabetes.

18-10-2002

297

Rabeprazole sodium

Each enteric coated tablet contains; rabeprazole sodium-10mg,20mg

Gastroesophageal reflux disease, deodenal ulcer & zollinger ellision syndrome.

27/12/2001

298

Ranolazine ER Tablets 750mg (Additional Strength)

Same as Approved

24.04.10

299

S(-) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets

For the treatment of high risk hypertensives who need anti-platelet therapy especially for prophylaxis of artherothrombotic events in patients with a history of recent stroke or established peripheral arterial disease.

22.09.11

300

Betaxolol ophthalmic gel forming solution

Each ml contains; betaxolol hcl BP eq.to betaxolol-2.5mg,5mg

New formulation (once daily administration)- for reduction of elevated intraocular pressure in patients with ocular hypertension & chronic open angle glaucoma.

25-10-2002

301

Calcium polycarbophil rablets

Each film coated tablet contains; calcium polycarbophil eq.to polycarbophil-500mg

2004-December

302

Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3 acidtriglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm +Ascorbypalmitate 0.30 gm + Sodium hydroxide Þ¡

For the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults if oral or enteral nutrition is impossible, inadequte or contraindicated.

14.05.09

303

Fluconazole (2%) + Zinc Pyrethione (1%) suspension

Each ml of lotion contains; fluconazole-20mg, zinc pyrithione-10mg

For the treatment of seborrhoic dermatitis.

22/02/2005

304

Each Combipack contains: -A) One tablet of Risedronate Sodium -Each film coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi-Pentahydrate) - 35 mg B) Six Capsules of FDC of Calcitriol Calcium carbonate + Zinc Each soft gelatin capsule cÞ¡

For the treatment of Osteoporosis in post menopausal women.

30.09.11

305

Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml)

For chronic Hepatitis-B infection.

05/12/2005

306

Human interferon alfa-2b (reombinant) inj.

Each vial contains; human interferon alfa-2b (recombinant)-3mIU,5mIU,10mIU

By cancer specialists-for multiple myeloma, kaposis sarcoma in patients with AIDS, malignant melanoma, hairy cell leukemia, chronic myelogenous leukemia, laryngeal papilimatosis, condylomate accuminata, superficial and nodulocerative basal cell carcinoma.

02/01/2001

307

Levocetirizine Di-HCl mouth dissolving tablets (5mg) (new dosage form)

Each uncoated tablet contains; levoceterizine di-HCl-5mg

For the treatment of allergic rhinitis and chronic urticaria.

27/07/2007

308

Rifaximine 200mg tab

For infections diarrhea in adults.

28/08/2006

309

Silver Wound Dressing

Dressing contains; silver sodium hydrogen zirconium phosphate-15Â±5%, nylon fiber-53Â±3%, polyester fiber-16Â±3%, polyurethane binder-4Â±2%, elastomer (Lycra) fiber-12Â±5%.

As an antimicrobial barrier for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

16.04.08

310

Tacrolimus Capsules 3mg (Additional Strength)

Same as Approved

24.04.10

311

Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg + Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets

For the treatment of hypertension: a) As initial therapy in the patient likely to need multiple drugs to achieve blood pressure control. B) In the patients whose blood pressure is not adequately controlled with the Aliskiren alone or Amlodipine (or anotheÞ¡

12.10.11

312

Aztreonam inj. & bulk

Each vial contains; aztreonam USP eq.to anhd. Aztreonam-0.5gm,1gm,2gm

Urinary tract infection, lower respiratory tract infection, septicemia, skin & skin structure infections, intra abdominal infections, gynecological infections.

01/11/2002

313

Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets

For the treatment of patients with typhoid fever and urinary tract infection in adults.

26.04.10

314

Diacerin 50mg + Glucosamine sulphate 500mg tablets

For the treatment of adult patients with osteoarthritis of knee and hip joints.

21.04.08

315

Idaravone Injection (1.5mg/ml)

For improvement of neurologic symptoms, disorders of activitis of daily living and functional disorder associated with acute ischemic stroke.

26/07/2007

316

Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops

Ophthalmic

07/12/2005

317

Nicotine transdermal patch

Each patch contains; nicotine-36mg,78mg,114mg

Without any presription of RMP. As an aid for smoking cessation.

11/01/2001

318

Nilutamide tablets

Each tablet contains; nilutamide-150mg (Additional strength)

Oncologists- for treatment of metastatic prostate cancer in combination with surgical castration.

2004-December

319

Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v

For the topical treatment of the superficial fungal infections of the skin.

02.05.09

320

Tigecycline powder For Inj. 50mg/vial

For skin & skin structure infection & intra abdominal infection.

28/08/2006

321

Amlodipine Tablets 5mg/10mg (additional indication)

1. To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke. 2. To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary arÞ¡

02.05.09

322

Balsalazide disod.cap & bulk import

Each hard gelatin cap contains; balsalazide disod.dihydrate-750mg

Mild to moderately active ulcerative colitis.

12/11/2002

323

Clostridium Botulinum type-A toxin haemagglutinin complex (Additional Indication)

For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy.

22.04.08

324

Diclofenac Sodium (75mg/ml) Injection (addl. Strength)

For management of painful conditions in post-operative cases, rheumatoid arthritis and osteoarthritis.

30/07/2007

325

Ferrous Ascorbate eq. to elemental iron 100mg + Folic acid IP 1.1mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength)

For the treatment of Iron deficiency anaemia.

19.10.11

326

Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet

For spasmodic pain.

08/12/2005

327

Liquid paraffin 6% + White soft paraffin 15% w/v Cream

For symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis.

29.04.10

328

Ramipril tablets/capsules

Additional indication;

2004-December

329

Ritonavir + Lopinavir capsules & oral suspension

Each soft gelatin capsule contains; ritonavir-33.3mg, lopinavir-133.3mg, Each ml of oral solution contains; ritonavir-20mg, lopinavir-80mg

By RMP- in treatment of HIV infection in combination with other retroviral agents.

18-01-2001

330

Stavudine SR 100mg tablet

Each SR tablet contains; stavudine-100mg

For the treatment of HIV infection in adults only.

29/08/2006

331

Amlodipine (as besylate) 5mg + Losartan Pot. 50mg

For hypertension.

08/12/2005

332

Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet

Treatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults.

19.10.11

333

Imedeen oral tablets

2005-October

334

Cefetamet pivoxil tab

Each film coated tab contains; cefetamet pivoxil hydrochloride-500mg, 250mg(appr.on 28-3-03)

Infections caused by susceptible microorganism found in otitis media, sinusitis, pharyngotonsillitis, acute exacerbation of chronic bronchitis, tracheobronchitis of bacterial origin, pneumonia, complicated & uncomplicated UTI, acute gonococcal urethritis Þ¡

14-11-2002

335

Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet

Antibiotic.

29/08/2006

336

Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet

For LRTI, URTI and UTI.

30/07/2007

337

Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (additional indication)

Prophylaxis of infection in neck and head surgery.

02.05.09

338

Fluconazole Dispersible tablets 50mg

Each uncoated tablet contains; fluconazole USP-50mg

For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy.

22.04.08

339

Imiquimod topical cream (5%) w/w

Each 0.25gm contains; imiquimod-12.5mg

By RMP- for the treatment of external genital/periannal warts in adults patients.

29/12/2004

340

Thiocholchicoside SR Tablet 16 mg

As an adjuvant treatment in painful spasms associated with degenerative vertebral disorders and vertebral static problems, torticollis dorsal pain, low back pain, traumatological and neurological disorders.

30.04.10

341

Thymosin alfa-1 inj.

Each vial contains; thymosin alfa-1 1.6mg (lyophilized)

By gastroenterologist- in treatment of chronic hepatitis-B in patients 18 years of age or older with compensated liver diseases and hepatitis-B virus (HBV) replication.

16-01-2001

342

Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength)

As approved

30/07/2007

343

Broncho vaxom capsules

Each capsule contains; lyophillized bacterial lysate-7mg made up of D.pneumoniae, H.influenzae, Klb.pneumoniae, S.aureus, streptococcus pyogens, neisseria catarrhalis

RMP- As adjuvant therapy in acute and chronic bronchitis for adults only.

12/02/2001

344

Ciclesonide 80mcg/160mcg + Formotorol 4.5mg inhaler

For the treatment of patients with bronchial asthma where use of said combination is found appropriate.

29/08/2006

345

Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules

For the treatment of chronic idiopathic constipation in adult patients only.

16.05.09

346

Gatifloxacin + Ambroxol tablets

Each tablet (film coated bilayered) contains; gatifloxacin sesquihydroate eq.to gatifloxacin-400mg, ambroxol hcl BP-75mg (SR form)

By RMP- for the treatment of respiratory tract infection by susceptible organisms in adults.

24/12/2004

347

Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v Eye Drops

For the treatment in the patients with inflammatory occular conditions where bacterial infection or a risk of bacterial occular infection exists.

24.10.11

348

Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication)

In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.

22.04.08

349

Parecoxib inj. i.v or i.m

Each vial contains; parecoxib sod.eq.to parecoxib-20mg,40mg

For short term treatment of post operative pain.

01/11/2002

350

Telmisartan 40/80 mg + Indapamide SR 1.5/1.5 mg tablet

For the treatment essential hypertension.

05.04.10

351

Travoprost Eye drops (40mcg/ml)

Each ml contains; travoprost-40mcg

For the reduction of intraocular pressure in patients with open angle glaucoma & ocular hypertension.

08/12/2005

352

Alprazolam sublingual tablets 0.5mg/1mg (New dosage form)

in the treatment of anxiety associated with depression and for the treatment of panic disorder.

27.10.11

353

Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength)

As approved

30/07/2007

354

Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection

For LRTI.

08/12/2005

355

Ciclesonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps

For the treatment of patients with bronchial asthma where use of said combination is found appropriate.

29/08/2006

356

Glimepiride + metformin SR tab

Each uncoated tab contains; glimepiride-1mg,2mg, metformin hcl IP-500mg in SR form

For patients with type 2 diabetes mellitus when diet, exercise & the single agent do not result in adequate glycemic control.

13-11-2002

357

Nebivolol + Hydrochlorthiazide

Each uncoated tablet contains; nebivolol hcl-eq.to nebivolo-5mg, HCTZ IP-12.5mg

RMP- for the treatment of essential hypertension.

23/12/2004

358

One strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg

Additional strength

05.04.10

359

Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets

As an adjunct to diet & exercise to improve glycemic control in patients with type-two diabetes mellitus.

28.04.08

360

Sucralose

for use as sweetner in drug formulations.

09.05.09

361

Verteporfin powder for solution for inj.

Each vial contains; verteporfin-15mg

By opthalmologists only- indicated for the treatment of age related macular degenration in patients with predominantly subfoveal choroidal neovascularisation.

20-03-2001

362

Abacavir Sulphate syrup 20mg/ml

Each ml contains; abacavir sulphate IP eq.to abacavir-20mg

For the treatment of patients with HIV Infection.

29/08/2006

363

Atomoxetine (as HCl) Sachet (10/18 /25/40mg)

For ADHD.

15/12/2005

364

Framycetin + Hydrocortisone + Fluconazole topical cream

Framycetin sulphate-1%, hydrocortisone acetate-1%, fluconazole nitrate-2%

1987-April

365

Atorvastatin + Fenofibrate

Each film coated tablet contains; atorvastatin calcium eq.to atorvastatin-10mg, fenofibrate BP (micronised)-160mg

By RMP- for the treatment of combined hyperlipidemia in patients with normal hepatic and renal function.

24/12/2004

366

Carvedilol Tablets 3.125/6.25/12.5/25mg (additional indication)

To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of â?¤ 40% (with or without symptomatic heart failure).

09.05.09

367

Cetrorelix acetate inj.

Each vial contains; 0.26-0.27mg cetrorelix acetate, 3.12-3.24mg cetrorelix acetate

By gynaecologists- prevention of premature ovulation in patients under going a controlled ovarian stimulation followed by oocyte picking and assisted reproductive techniques.

22-03-2001

368

Gemcitabine Hydrochloride for injection 2g/vial (New dosage form)

In the management of non small cell lung cancer.

27.10.11

369

Lansoprazole for injection 30mg/vial

Each vial contains; lansoprazole-30mg

For short term treatment of errosive esophagitis when patients are unable to take the oral formulation.

28.04.08

370

Lapatinib Ditosylate Tablets 250mg (addl. Indication)

In combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.

10.05.10

371

Telmisartan tab

Each uncoated tab contains telmisartan-20mg,40mg,80mg

For mild to moderate hypertension.

25-11-2002

372

VSL # 3 (Probiotic Blend) sachet

For rotavirus diarrhoea in children.

31/07/2007

373

Aluminium sodium silicate, magnesium hydroxide, methyl polysiloxane

1 mg, 10 tablets

In the treatment of peptic ulcer gastric hyperacidity, heart burn and flatulence.

1967- June

374

Amikacin injection

Each vial contains; amikacin sulphate eq.to 100mg,250mg,500mg of amikacin

Antibiotic- Indicated in the treatment of serious infections due to amikacin sensitive organisms.

1986-June

375

Azacitidine Injection 100mg/vial

Each single dose vial conatins; azacitidine-100mg

For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome.

01.09.15

376

Benzydamine topical cream

Benzydamine hcl-3%

Topical analgesic- Indicated in the treatment of musculo-skeletal pain only.

1988-May

377

Betamethasone Benzoate

1978-August

378

Biperiden lactate

Each ml contains; biperiden lactate-5 mg

Parkinsonism

1972- October

379

Brimonidine tartrate ophthamic solution

Brimonidine tartrate-0.2% eq.to brimonidine base-0.13%

For lowering intraocular presuure in patients with open angle glaucoma or ocular hypertension.

18-05-1999

380

Broxyquinoline & Brobenzoxa lidine

250 mg, 200 mg tabs

Intestinal antiseptic, antiamoebic.

1963- May

381

Celecoxib

Each capsule contains; celecoxib-100mg,200mg

For treatment of R.A & O.A

22-02-2000

382

Clonidine Hcl + Hydrochlorthiazide

Clonidin Hcl-100mcg+ Hydrochlorthiazide-20mg

Antihypertensive agent- indicated in the treatment of hypertension.

1975-July

383

Clonidin Hcl

Each tablet/capsule contains; Clonidin Hcl-100mcg,

Antihypertensive agent- indicated in the treatment of hypertension.

1975-July

384

Clorexolone

10mg & 25mg tablets

Hypertensive, cardiac failure, oedema, diabetes insipidus.

1968- October

385

Decitabine Lyophilized powder for injection 50mg/20ml vial

Each 20ml vial contains; decitabine-50mg

For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia wÞ¡

28.04.09

386

Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system)

For the treatment of non-infectious uveitis affecting the posterior segment of the eye. However it should not be used when there is gap in posterior capsule.

20.02.13

387

Dipiprolate

Dragee-40mg

Anti-tussive.

1964- March

388

D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength)

Same as Approved.

07.01.08

389

Eltrombopag olamine tablets 25mg/50mg (Additional Indication)

Each film coated tablet contains; eltrombopag olamine eq.to eltrombopag olamine as free acid-25mg, 50mg

Indicated in patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia to: Enable the initiation of interferon based therapy, optimise interferon based therapy.

07.04.14

390

Ethyl esters of iodized fatty acids of poppy seed oil solution for injection 48%.

Each ampoule contains; ethyl esters of iodized fatty acids of poppy seed oil qs Iodine content; 48%, i.e. 480mg per ml

In Diagnostic Radiology: Lymphography and Diagnosis of liver lesions. (Diagnosis of the spread of malignant lesions, whether hepatic or not, by selective hepatic arterial injection). In Interventional Radiology: Embolization with surgicaÞ¡

22.08.2012

391

Etofylline + salbutamol SR Caps.

Each SR cap.contains; etofylline-300mg, salbutamol (as sulfate)-4mg

14/06/1993

392

Famotidine tablet/oral suspension

Tablet famotidine-20mg,40mg, 10mg(Intas-28-10-94), oral suspension-each 5ml contains; famotidine-40mg

Anti ulcer- Indicated in the treatment of duodenal & peptic ulcer, zollinger ellison syndrome.

1989-May

393

Hydrocortisone acetate + Nitrofurazone

Hydrocortisone acetate-1%w/w, Nitrofurazone-0.2%w/w

1973-June

394

Ibuprofen controlled release

Each controlled release tablet contains ibuprofen 600mg, Each SR cap contain ibuprofen 200mg,300mg,400mg,800mg

For chronic arthritic disorders and painful musculoskeletal conditions.

1990- March

395

Imidapril hcl tablets

Each tablet contains; imidapril hcl-2.5mg,5mg,10mg

By RMP only- for the treatment of mild to moderate hypertension.

23/02/2004

396

Lamivudine tablet/oral solution/bulk

i)-Each uncoated tab contains; lamivudine-150mg, 100mg(for chronic hepatitis on 25-10-99), ii)-Each 5ml contains; lamivudine-50mg, 25mg(30-12-99, cadila)

As an adjunct to other anti retroviral agents in prgressive HIV infection and chronic hepatitis B virus (HBV).

27/03/1998

397

L-dihydroxyphenylalanine

Each tablet/capsule contains; L-dihydroxyphenylalanine-500 mg.

1971- May

398

Levodopa + Carbidopa tablets

Parkinsonism-for the treatment of Parkinson's disease.

1983-December

399

Levosimendan Injection 2.5mg / ml

Each ml contains; levosimendan-2.5mg

For the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient and in cases where inotropic support is considered appropriate.

04.05.10

400

Lynestranol-2.5 mg + Ethinyloestradiol-50 mcg

Oral contraceptive

1970- September

401

Lynestrenol + Ehinylestradiol

Each tablet contains; Lynestrenol-0.75mg, Ehinylestradiol-37.5mcg

Oral contraceptive

1979-April

402

Meglumine salt of Loxitalamic acid

Telebrix 38-Each 20mL ampoule contains; Sodium salt of loxitalamic acid-5.13gm, Meglumine salt of loxiralamic acid-10.26gm, Vasobrix 32-Meglumine & sodium salt of loxitalanic acid-62.5%

X-ray contrast media- for cerebral angiography & urography.

1977-September

403

Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg

For hypertension.

07/02/2006

404

Metoprolol with hydrochlorthiazide tablets

Each tablet contains; metoprolol tartrate-100mg, hydrochlorthiazid-12.5mg

1982-October

405

Metronidazole Benzoate

Each 5mL suspension contains; Metronidazole Benzoate eq. to 200mg of Metronidazole

1976-August

406

Mianserin hydrochloride

Each tablet contains; mianserin hcl-10mg,20mg,30mg

Anti depressant- Indicated in the treatment of endogenous reactive depression anxiety, agitation and insomnia where associated with depressive illness.

1985-August

407

Midazolam inj. BP

Each vial contains; (5ml/10ml), Midazolam BP-1mg/ml (as hydri), Each ampouled prefilled syringe contains; midazolam-5mg/ml (as)

Anaesthetic general-For preoperative sedation for conscious sedation prior to short diagnostic or endoscopic procedure and for induction of general anaesthesia prior to administration of another anaesthetic agent.

15/04/1997

408

Mirtazapine

Each film coated tablet contains; mirtazapine-15mg, 30mg, 45mg

By psychiatrist only-for major depression.

13-02-2001

409

Morphine sulphate CR tablets

Each film coated CR tablet contains; morphine sulphate-60mg

18/07/1994

410

Nitrendipine

Each tablet contains; nitrendipine-10mg,20mg

Anti hypertensive- In the treatment of mild to moderate hypertension.

1991- May

411

Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer)

For gastric ulcer, duodenal ulcer, Z. E Syndrome, GERD.

07.02.07

412

Paromomycin

600 mg per day, in divided dose of 150mg 4 times

Antibiotic for amoebiasis.

1961- March

413

Phenosulf inj.

Each ml contains; 25mg of phenylmethylamine-p-amino benzene sulphonate.

1969- July

414

Polyvinyl alcohol ophthalmic solution

Each ml contains; polyvinyl alcohol-14mg,30mg, Benzalkonium chloride-8.05mg

16/05/1996

415

Pyritinol

Cerebral stimulant

1965- April

416

r-human interferon beta 1a soln for inj.

Each prefilled syringe of 0.5ml soln contains; r-human interferon beta 1a- 22mcg (6m iu/0.5ml), 44mcg (12m iu/0.5ml)

For treatment of patients with relapsing/remitting multiple sclerosis ch characterised by at least 2 recurrent attacks with neurological symptoms over the preceding 2 years.

18-01-2002

417

Sacubutril+ Valsartan film coated tablets 50mg/100 mg/200mg

Each film coated tablet contains; sacubutril + valsartan 50 (24+26)mg/ sacubutril + valsartan 100 (49+51)mg/ sacubutril + valsartan 200 (97+103)mg

To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

14.07.16

418

Silodosin Capsules2mg/4mg/8mg

Each capsule contains; silodosin-2mg, 4mg, 8mg

For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only.

23.06.11

419

Sorbide nitrate

10 mg

Coronary vasodilator.

1962- April

420

Sulphadoxine

The drug sulphadoxine should be used only in the manufacture of tablets containing this drug in combination with pyrimethamine for the treatment of cases of malaria which are resistent to chloroquine.

1981-April

421

Deferasirox dispersible tablet (400mg) (addl. Strength)

As approved

17/08/2007

422

Tacrolimus ointment 0.03% & 0.1% (Not for children)

Each gm of ointment contains tacrolimus-0.3mg & 1mg

For dermatologists-For treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative convetional therapy is advisable.

07.03.2003

423

Terfinadine + Pseudoephedrine hcl E.R tabs

Each tablet contains; terfinadine-60mg, pseudoephedrine hcl-120mg (as extended release)

24/03/1995

424

Tretinoin + Cream tretinoin

Each Swab contains; Tretinoin-0.05%, Cream-Tretinoin 0.05%

1974-July

425

Xipamide

Each tablet contains; Xipamide-40mg

Diuretic, indicated in the treatment of oedema and hypertension only

1980-July

426

Allopurinol SR caps

Each SR cap contains; allopurinol-250mg

For treatment & prophylaxis of gout.

22-11-2002

427

Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets

For the treatment of Acute musculoskeletal pain.

18.05.09

428

Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage Form)

For the treatment of acute inflammation conditions associated with spasm in adults only.

15.11.11

429

Ethamsylate + Tranexamic acid

Each film coated tablet contains; tranexamic acid BP-250mg, ethamsylate BP-250mg

By RMP- for the treatment of abnormal blood loss due to menorrhagia, local fibrinolysis and intra operative/post operative hemorrhage.

29/12/2004

430

Imidacloprid cutaneous solution

Each tube contains; imidacloprid 40mg,100mg,250mg

Prevention & treatment of flee infestation on dogs.

23-03-2001

431

Indapamide (SR) 1.5mg/1.5mg + Nebivolol 2.5mg/5mg tablet

For the treatment of hypertension not controlled with monotherapy.

12.05.10

432

Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl.Strength)

Ophthalmic

16/12/2005

433

Naproxen Suspension 125mg/5ml

Each 5ml contains; naproxen-125mg

For the treatment of rheumatoid arthritis in children 5 years of age and above.

28.04.08

434

Sorafenib (as Tosylate) (200mg) Tablet

Each tablet contains; sorafenib tosylate eq.to sorafenib-200mg

For the treatment of patients with advanced renal cell carcinoma.

01.08.07

435

S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet

Each capsule contains; S(-) pantoprazole sodium eq.to S(-) pantoprazole-20mg (enteric coated), domperidone BP (SR)-30mg

For the treatment of GERD not responding to S(-) pantoprazole alone.

30/08/2006

436

Cefadroxil 500mg + Clavulanic acid 125mg tablet

For the treatment of adult patients with infections caused by susceptible microbes including S. Aureus viz. UTI, LRTI and gonococcal urethritis.

30/08/2006

437

Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules

For the treatment of gastirc ulcer,gastroesophageal reflux disease(GERD) & Dyspepsia not responding to omeprazole alone.

12.05.10

438

Collagen dressing soft sponge (gel fix)

Each 5X5cm sponge contains; 250mg eq.to collagen anhydrous 210mg, each 1X1cm sponge contains; 10mg eq.to collagen anhydrous 84mg

RMP- As adjuvant in post surgical characterization of various ulcers & dicubitus sores.

23-04-2001

439

Imatinib mesylate 100 mg/400mg Tablets (Additional Indication)

1. Adjuvant treatment of adult patients following resection of gastro- intestinal stromal tumours (GIST) 2. For the treatment of CML in blast crisis, accelerated phase or in chronic phase after failure of interferon alpha therapy. 3. Newly diagnosed PhilaÞ¡

15.11.11

440

Lovastatin + Niacin

Each film coated tab contains; lovastatin USP-20mg, niacin IP-500mg(ER form).

By RMP- for the treatment of primary hyperlipidemia & mixed dyslipidimia in patients treated with i)-lovastatin who require further TG lowering or HDL raising or ii)-with niacin who are require further LDL lowering. It is not indicated for initial therapyÞ¡

24/12/2004

441

Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule

For diabetic neuropathy.

31/07/2007

442

Pregabalin SR Tablet 150/300mg

For the treatment of peripheral neuropathic pain in adults.

16.05.09

443

Sevelamer Carbonate 400mg/800mg tablets & sachet 400mg/800mg

1) Each film coated tablet contains; sevelamer carbonate-400mg, 800mg, 2) Each sachet contains; sevelamer carbonate-400mg, 800mg

For the control of serum phosphorus in patients with chronic kidney disease on dialysis.

28.04.08

444

Tinidazole CDDS tab

Each tab contains; tinidazole-500mg

For amoebiasis & giardiasis in adult patients only.

25-11-2002

445

Zonisamide (100mg) capsule

Anti-epileptic.

21/12/2005

446

Bioceramic composite materials

Each glass vial contains; hydroxyapatite 100% granules, each glass vial contains; hydroyapatite 90%+beta tri calcium phosphate 10% as granules, each vial contains; hydroxyapatite paste as 30% & 18% suspension

For acute cases of bone deformities only as bone grafting material

22-11-2002

447

Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet

For the treatment of adult patients with infections caused by susceptible microbes including S. Aureus viz. UTI, LRTI and gonococcal urethritis.

30/08/2006

448

Epalrestat 50mg + Methylcobalamin 500mcg Tablets

For the treatment of Diabetic Neuropathy.

16.11.11

449

Guaiphenesin ER Tablet 1200mg

For the treatment of productive cough accompanied by Phlegm.

16.05.09

450

Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment

For plaque psoriasis.

01/08/2007

451

Methimazole Tablet (5mg/10mg)

For hyperthyroidism.

22/12/2005

452

Terbinafine tab/cream

tablet-250mg, cream-1%

Fungal infection of skin,hair nails.

29/03/1995

453

Pantoprazole + Domperidone SR

Each capsule contains; pantoprazole sod.sesquihydrate eq.to pantoprazole-40mg, domperidone BP-10mg.

By RMP- for the treatment of gastroesophagal reflux diseases (GERD) not responding to pantoprazole.

24/12/2004

454

Pyrantel embonate with fabental suspension

Each ml of suspension contains; pyrantel embonate-14.4mg, febental-15mg

For treatment of infestation caused by round worms, ascarids, hook worms, whip worm in puppies & young dogs.

23-04-2001

455

Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tablets

For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD.

28.04.08

456

Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml

For the treatment of elevated intraocular pressure in patient with ocular hypertension or open angle glaucoma.

14.05.10

457

Caspofungin Acetate injection (50mg/70mg per vial)

For invasive candidiasis fungal infection.

23/12/2005

458

Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup

For the treatment of adult patients with infections caused by susceptible microbes including S. Aureus viz. UTI, LRTI and gonococcal urethritis.

30/08/2006

459

Combined hepatitis A & hepatitis B vaccine inj. (import of finished formulation)

Each ml contains; NLT 720 EU of in activated hepatitis A virus+20mcg of HBs Ag protein (rDNA), each 0.5ml dose contains; NLT 360 EU of inactivated HA Virus+10mcg of rDNA HBs Ag protein.

By RMP- use in non-immune adults and adolescents 16 years of age and children from 1 year to 15 years of age who are at risk of both hepatitis A and hepatitis B vaccine.

07/06/2001

460

Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength)

As Approved

01/08/2007

461

Everolimus 5/10mg Tablets (Addl. Indication)

Treatment of advance renal cell carcinoma.

16.05.09

462

Iron sucrose injection

Eacg 5ml contains; iron (as iron sucrose)-100mg

Indicated in iron deficiency anemia in which rapid and reliable substitution of iron is required.

25/03/2004

463

Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg ophthalmic solution

For the treatment of seasonal allergic conjunctivitis in adults only.

21.11.11

464

Pantoprazole Sodium (With Sodium bicarbonate as buffer) 20mg/40mg tablets

For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD.

28.04.08

465

Rosiglitazone + glimepiride tab

Each film coated tab contains rosiglitazone maleate eq.to rosiglitazone-2mg, glimepiride-1mg

Type-II diabetes mellitus where diet, exercise & single agent do not result in adequate glycemic control.

14-11-2002

466

Sufentanyl citrate i.v injection

2004

467

Telmisartan tablet 20/40/80 mg (Additional indication)

For the prevention of cardiovascular morbidity and mortality in patient 55 years older at high risk of cardiovascular disease.

14.05.10

468

Amino acids 10% inj.

Each 100ml contains; l-isoleucine-0.670g, l-leucine-1.000g, l-valine-0.760g, l-lysine-1.100g, l-methionine-0.240g, l-phenylalanine-0.120g, l-threonine-0.370g, l-tryptophan-0.200g, l-arginine-0.840g, l-histidine-0.380g, l-alanine-0.800g, l-aspartic acid-0.Þ¡

For prophylaxis & therapeutic treatment of protein depletion in children where oral/enternal nutrition is impossible/impracticable.

19/01/2004

469

Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml

For the treatment of community acquired pneumonia, acute exacerabation of chronic bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis.

29.04.08

470

Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets

For the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult patients.

20.05.10

471

Dutasteride capsules

Each soft gelatin capsule contains; dutasteride-0.5mg

By urologists only- for the treatment of symptomatic Benign Prostatic hyperplasia (BPH) in men with an enlarged prostate.

13/02/2004

472

Entocapone tablets

Each film coated tablet contains; entocapone-200mg

By neurologists- adjunct to levodopa & dopa decarboxylase inhibitor in Parkinson's disease patients with end-of-use motor fluctuations, who can not be stabilized on these combinations.

03/01/2005

473

Human Insulin (r-DNA) Powder inhaler

For type-I & Type-2 Diabetes.

30/08/2006

474

Nimesulide ER 200mg (Additional Indication)

Acute pain in Orthopaedic, ENT, Dental and Post Operative condition.

16.05.09

475

Omeprazole (20mg/40mg) + Sod. Bicarbonate-600mg + Mg.Hydroxide-700mg .chew tab.

For duodenal, gastric ulcer, GERD, and erosive esophagitis.

01/08/2007

476

Poractant alpha

Each 1.5ml & 3ml vial contains; phospholipid fraction from porcine lung-120mg,240mg

For respiratory distress syndrome in preterm babies.

24-12-2002

477

Toltrazuril 2.5% solution

Each 100ml contains; toltrazuril-2.5gm

For treatment of coccoidiasis in poultry.

08/06/2001

478

Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg Tablets

For the symptomatic treatment of moderate to severe pain in adult patients.

21.11.11

479

Adefovir dipivoxil (Tab/bulk)

Each tablet contains; adefovir dipivoxil-10mg

For treatment of chronic hepatitis B infection, in adults with evidences of active viral replication either evidences of persistent elevation of serum aminotransferases or histologically active disease.

04/03/2004

480

Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength)

For the treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is appropriate.

21.11.11

481

Efavirenz

Each capsule contains; efavirenz 50mg,100mg,200mg

By RMP- in treatment of HIV-1 infection in combination with other antiretroviral agents.

06/06/2001

482

Fulvestrant Inj. 250mg/5ml prefilled syringe

Anti Cancer.

30/08/2006

483

Gefitinib

Anticancer

17/02/2004

484

Palonesetron Injection 0.25mg/5ml (Additional Indication)

For treatment of Post Operative Nausea & vomiting.

16.05.09

485

Pregabalin capsules (Addl. Indication)

Management of fibromyalgia syndrome.

29.04.08

486

Ramipril tablets

1.25mg, 2.5mg, 5mg, 10mg

For additional indication; reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularization, procedures in diabetic patients 55 yrs of age or more with one or more of the following rosk factors, syst. B.P >160mmHg or diastol.Þ¡

2005

487

Reboxetine tab

Each uncoated tab contains; reboxetine methane sulphonate eq.to reboxetine-2mg,4mg

Mild to moderate depression in adults only.

31-12-2002

488

Rosuvastatin Calcium Tablet (Additional Indication)

Risk reduction of MI stroke and arterial evascularisation procedure in patients without clinically evident CHD but with multiple risk factor.

24.05.10

489

Hydroxyethyl starch (130/0.4) i.v infusion

Each 100ml contains; hydroxyethyl starch (130/0.4)-6gm

By specialists only- For the treatment & prophylaxis of hypovolaemia & shock due to surgery, trauma, burns, infections, therapeutic haemodilution, extracorporea circulation and leukapheresis.

2005-February

490

Letrozole 2.5mg tablet (additional indication)

Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy.

28/12/2004

491

Meglumine ioxaglate sodium + sodium ioxaglate i.v inj.

Urography, angiography, arthrography, G.I examination, hysterosalpingography, sialography.

16-08-2001

492

Neotame (sweeting agent)

2004-March

493

Ondansetron Fast Dissolving Strips 4mg/8mg (New dosage form)

1) for chemotherapy induced nausea and vomiting. 2)for post-operative nausea and vomiting.

22.11.11

494

Paracetamol SR 1000mg Bilayered tablet

For symptomatic treatment of pain and fever.

24.05.10

495

Perindopril arginine 2.5mg/5mg/10mg film coated tablet

For the treatment of arterial hypertension, congestive heart failure and coronary artery disease.

16.05.09

496

Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength)

Same as Approved.

08.05.08

497

Sirolimus tab

Each uncoated tab contains; sirolimus-1mg

For prophylaxis of organ rejection in patients receiving renal transplant along with the regimens of cyclosporins & corticosteroids.

31-12-2002

498

S(-) Pantoprazole (as Sodium) Inj. 20mg/vial

Each vial contains; S(-) pantoprazole sodium eq.to S(-) pantoprazole-20mg

For the treatment of patients with peptic ulcer, GERD & Zollinger Ellison Syndrome.

31/08/2005

499

Tegafur (100mg) + Uracil (224mg) capsule

For first line treatment of metastatic colorectal cancer in combination with calcium folinate.

22/08/2007

500

Aliskiren 150/150/300/300mg + Hydrochlorthiazide 12.5/25/12.5/25mg tablets

For the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy.

08.05.08

501

Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + Olmesartan Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet

For the treatment of essential hypertension.

23.11.11

502

Bortezomib Injection (additional indication)

For the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

05/09/2007

503

Dasatinib tablet 20mg/50mg/70mg tablet

For the treatment of adults with chronic accelerated or myeloid or lymphoid blast phase chronic myeloid leukemai (CML).

30/08/2006

504

DTaP vaccine

Each 0.5ml contains; components of pertussis (pertussis toxoid:10mcg, filamentous hemagglutinin:5mcg, fimbrial (agglutinogens 243):5mcg, pertactin:3mcg (69KDa membrane protein), diptheria toxoid:15Lf, tetanus toxoid:5Lf

Primary immunization of infants at or above the age of 2 months and as a booster in children upto their 7th birthday against diptheria, tetanus & whooping cough.

01/02/2002

505

Dural graft implant

Primarily composed of type I bovine collagen

By specialists only- for use in procedures where the repair of substitution of the patients dura matter is intended.

15/02/2005

506

Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel

For the topical treatment of inflammatory dermatitis withsecondry bacterial infection.

16.05.09

507

Imatinib mesilate capsules

Each cap contains; imatinib mesilate (eq.to free imatinib base)-100mg

Oncologists only- for chronic myeloid leukemia (CML) in blast crisis accelerated phase or in chronic phase after failure of IFN-alfa therapy.

04/12/2001

508

Oxybutynine E.R. Tablets

For Neurogenic bladder disorder.

05.05.2004

509

S(-) amlodipine + Hydrochlorthiazide tablets

Each uncoated tablet contains; s(-) amlodipine besylate eq.to s(-) amlodipine-2.5mg, 5mg, Hydrchlorthiazide-12.5mg

By RMP- for the treatment of mild to moderate hypertension.

14/04/2004

510

Tacrolimus PR Caps 0.5/1/5 mg

For Prophylaxis of transplant rejection in adult kidney or liver allograft rejection.

24.05.10

511

Alfuzocin hcl. OD(10mg) tablets

Each extended release film coated tablet contains; alfuzocin hcl ER-10mg

By urologists only- for the treatment of sign & symptoms of BPH.

14/05/2004

512

Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength)

As approved

06/09/2007

513

Cefprozil 125mg/250mg Dispersible Tablet

Anti-biotic.

22.06.2004

514

Clostridium botulinum toxin type A haemagglutin complex

Dysport injection-500 units

NOC for shelf life extension of 12 months to 15 months under 2áµ? to 8áµ?.

2005-February

515

Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets

For diabetes insipidus and noctural emuresis.

08.05.08

516

Each Combipack contains Part (A) One Strip of FDC of Ramipril + Amlodipine Tablets;-Each uncoated tablet contains Ramipril IP - 5mg, Amlodipine besylate IP eq to Amlodipine 5mg B) Each Film coated tablet contains ;- Atorvastatin Calcium IP eq to AtorvastaÞ¡

For the treatment of hypertension and as an adjunct to diet in patients to reduce elevated total cholesterol and triglyceride levels hypertension and dyslipidemia. The polypack should be used in patients for whom treatment with all of the three i.e RamiprÞ¡

28.11.11

517

Miltefosine capsule

Each capsule contains; miltefosine-10mg, 50mg.

For the treatment of visceral leishmaniasis.

15/03/2002

518

Mometasone 0.1 % + Fusidic acid 2% cream/ointment

For the treatment of dermatoses where secondry bacterial and/orcandidial infection is present.

25.04.09

519

Rizatriptan Benzoate orally disintegrating tablet 10mg (Additional Dosage Form)

Same as Already approved

24.05.10

520

Telbivudine 600mg tablet

Each film coated tablet contains; Telbivudine 600mg

For the treatment of adult patients with chronic hepatitis B infection with evidence of viral replication and active liver inflammation.

30/08/2006

521

Aprepitant cap (80mg/125mg)

For chemotherapy induced nausea & vomiting.

30/08/2006

522

Ceftazidine (2gm) + Sulbactam (1gm) Injection ( addl. strength for additional indication)

For serious abdominal infection.

06/09/2007

523

Contractubex gel

Each gm of gel contains; extract cepae-1gm, heparin sodium-500 IU, allantoin-0.1gm

Hypertrophic keloidal scars, movement restricting and cosmetically disfiguring scars after operations, amputation, burns and accidents and traumatic tendon contractions, cicatricial strictures.

15/03/2002

524

Docetaxel injection

20mg/0.5ml anhydrous concentrate & solvent for i.v infusion.

Additional indication; for the treatment of patients with hormone refractory metastatic prostate cancer in combination with prednisolone or prednisolone.

09/03/2005

525

Lithium Carbonate 450mg ER Tablet

Anti-Depression.

28.06.2004

526

Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength)

Same as Approved.

14.05.08

527

Ramipril 1.25/ 2.5/5/10mg (Additional Indication)

For the treatment ofnon-diabetic overt glomerular or incipient nephropathy.

24.05.10

528

Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets

Additional strength.

25.04.09

529

Tiagabine hcl tablets

Each film coated tablet contains; tiagabine hcl USP-2mg,4mg,12mg,16mg.

By neurologists- as adjunctive therapy in treatment of partial seizure in adults and children 12 years and above.

2004

530

Topotecan Hydrochloride capsules 0.25/1mg (New dosage form)

same as approved

28.11.11

531

Activated Methylpolysiloxane + Magnesium Hydroxide + Aluminium Hydroxide

Each 5mL contains; Activated Methylpolysiloxane-125mg, Magnesium Hydroxide-100mg, Aluminium Hydroxide-5mg

1973-June

532

Amiodarone hcl

Each tab contains; 100mg,200mg, Each 3ml ampoule (inj.) contains; amiodarone hcl-150mg

In the treatment of control of ventricular and supraventricular arrhythmia where other drug cannot be used, arrhythmia associated with wolf-white syndrome.

1990- April

533

Amrinone injection

Each ml contains; amrinone lactate eq.to 5mg amrinone base.

Inotropic agent- Indicated for the short term management of congestive heart failure.

1988-May

534

Atosiban Acetate Injection 6.75mg/0.9 ml, 1 ml & 5 ml Vial

Each 0.9ml and 5ml contains; atosiban acetate eq.to atosiban-6.75mg/0.9ml and 37.5mg/5ml respectively

â??Indicated to delay imminent pre-term birth in pregnant adult women with: -regular uterine contractions of at least 30 seconds duration at a rate of â?¥ 4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of â?¥ 50% - a gesÞ¡

16.09.15

535

Azathioprine

Each tablet contains; azathioprine-50mg & 100 mg

For facilitating the survival and function of organ transplants.

1969- July

536

Azelaic acid Cream (15%)

Each gm of cream contains; azelaic acid-0.15gm (15% w/w)

For topical treatment of mild to moderate inflammatory papules and pustules of mild to moderate rosacea.

23/02/2005

537

Biphenyl acetic gel

Each 15gm tube contains; biphenyl acetic-3.00% w/w

For the relief of symptems of soft tissue injuries, extra articular rheumatic or inflammatory conditions, acute inflammatory manifestations of osteoarthritis of knee joint pain, and swelling following injury.

27/04/1998

538

Cape aloes + podophyllum resin + licorice powder

Each tablet contains; Cape aloes IP-16mg, podophyllum resin IP-4.2mg, licorice powder IP-5.462mg

1972- October

539

Cefixime Tablets 200mg & Cefixime Oral Suspension 100mg/5ml

For the treatment of enteric (typhpoid) fever.

22.02.13

540

Ceftazidime 500mg + Tobramycin 60mg per vial (Injection)

For the treatment of lower respiratory tract infection caused by pseudomonas aeruginosa.

08.01.08

541

Ciprofloxacin bulk

1989-May

542

Clonidine Hcl

Each tablet contains; Clonidine Hcl-0.15mg

1975-July

543

Retapamulin Ointment 1%

Each gram contains; retapamulin-10mg

For the topical treatment of bacterial skin and skin structure infections:- Primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses.

28.04.09

544

Conivaptan Hydrochloride Injection 20mg/4ml.

Each 4ml ampoule contains; conivaptan hydrochloride-20mg

For the treatment of euvolemic hyponatremia (e.g. the syndrome of inappropriate secretion of antidiuretic hormone , or in the setting of hypothyroidism, adrenal insufficiency, pulmonary disorders, etc.) in hospitalized patients.

21.08.2012

545

Cyproheptadine Hcl.

4-20 mg

Anti-histamic, anti-serotonin.

1962- April

546

Dimethyl polysiloxone + Enzyme Concentrate + Apergillus argae + Protease + Cellulose + Hemicellulose + Amylase + Papaverine Hcl

Each capsule contains; Dimethyl polysiloxone-100mg, Enzyme Concentrate Apergillus oryzae-120mg, Protease-126willstatter units, Cellulose-185 Grassmann units, Hemicellulose-64 Grassman units, Amylase-1.3 willstaller units, Papaverine Hcl-25mg

1978-August

547

Dipivefrin hcl ophthalmic solution USP

Dipivefrin hcl USP-0.1%

For the control of intra-ocular pressure in chronic open angle glaucoma.

16/05/1996

548

Dipyridamole

tab-12.5mg, amp-2ml of 10mg

Coronary vasodilator.

1964- April

549

d-Norgestrel

Each tablet contains; d-Norgestrel-0.03mg

1974- August

550

Doxofylline Tablet (400mg)

For bronchial asthma & COPD.

08/02/2006

551

Doxorubicin Hcl

Each vial contains; Doxorubicin Hcl-10mg

Cancer specialists

1976-August

552

Feracrylum gel & sterile cotton guaze

Each gm of gel contains; feracrylum-10mg (1%), cotton gauze (30cm*30cm) contains feracrylum 1% solution.

By RMP- for the management of post operative wound,cuts,abrasion,as an haematinic agent.

15-02-2001

553

Fluorometholone + Gentamicin eye drops

Each ml contains; fluorometholone-1mg, gentamicin-3mg (as sulphate)

The infection of the anterior segment of the eye due to bacterial susceptible to gentamicin.

28/04/1997

554

Flutamide

Each tablet contains; flutamide-250mg

Oral anti cancer- Indicated for pallative treatment of advanced prostatic cancer only.

1986-June

555

Fluvoxamine maleate

Each film coated tab contains; fluvoxamine maleate-50mg,100mg

In treatment of obsessive compulsive disorder and depression.

21-02-2000

556

Iron dextran glycoside

5 & 10 ml ampl.

iron deficiency anaemia.

1967- June

557

Isosorbide-5 mononitrate

Each SR Tablet contains; isosorbide-5-mononitrate-50mg,25mg, 40mg(Nicholas 3-11-97)

Indicated in prophylaxis of angina pectoris, CHD post NI, therapy pulmonary hypertension.

1991- May

558

Isosorbide mononitrate tablets

Each tablet contains; isosorbide mononitrate-20mg,40mg, 10mg(sun pharma, 9-8-89)

Cardiac drug- Indicated in the treatment of coronary heart disease prophylaxis of angina pectoris follow up treatment of myocardial infarction, pulmonary hypertension.

1985-August

559

Levamisole Hydrochloride

Levamisole Hydrochloride-15% w/w & 30% w/v, Injection-Levamisole-18.2% w/v

1980-July

560

levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet

For lower respiratory tract infection in adult.

08.02.07

561

Loratidine nasal spray

Each 0.05ml actuation delivers 200mcg loratidine.

2004

562

Loratidine tablets

Each tablet contains; loratidine 10mg.

Long acting anti histaminic- In treatment of allergic rhinitis, acute coryza, chronic idiopathic urticaria.

19/06/1992

563

Lurasidone Hydrochloride Bulk & Lurasidone Hydrochloride Tablets 40mg/80mg

Each film coated tablet contains; lurasidone hydrochloride-40mg, 80mg

For the treatment of patients with schizophrenia.

18.07.16

564

Mosapride + MPS(methyl polysiloxane) Chewable tabs

Each uncoated chewable tab contains mosapride citrate dihydrate eq.to mosapride citrate-5mg, MPS (Methyl poly siloxane)-125mg

Gastro esophageal reflux disorder G.I symptoms, (heart burn/vomiting) associated with chronic gastritis.

30-01-2002

565

Norethindrone-1mg + Mestranol-0.05mg

Each tablet contains; Norethindrone-1mg + Mestranol-0.05mg

Oral contraceptive

1970- September

566

Oxyfedrine

Each forte tablet contains; Oxyfedrine-24mg

1979-April

567

Paclitaxel inj.

5ml single dose vial contains; paclitaxel-30mg

Advanced epithelial carcinoma of the ovary after failure of first line or subsequent chemotherapy.

25/08/1994

568

Pentosan polysulfate Sodium CapsulesÂ 100mg

Each capsule contains; pentosan polysulfate sodium-100mg

For the relief of bladder pain or discomfort associated with interstitial cystitis.

11.05.10

569

Procarbazine Hydrochloride USP

Indicated in the treatment of Hodgkins disease

1981-April

570

Propranolol with bendrofluazide capsules

Each capsule contains; propranolol hydrocloride-80mg, bendrofluazide-2.5mg

1982-October

571

Pyridine 3-carboxylic acid hydroxy methylamide + choline bitartrate

Each tablet contains; PCAHM-0.125g, cholie bitartrate-0.125g

1971- July

572

Quinapril + Hydrochlorthiazide tab

Each film coated tab contains; quinapril hcl eq.to quinapril-10mg,20mg, hydrochlorthiazide IP-12.5mg

For treatment of mild to moderate hypertension.

10/02/2003

573

Sulphinpyrazone USP

1977-September

574

Thioproperazine

Tab-1mg, 5mg, 10mg, 25mg, amp-0.75%

Neuroleptic

1963- June

575

Tiapride Hydrochloride Tablets 25mg/50mg/100mg

Each uncoated tablet contains; tiapride hydrochloride ph. Eur. Eq.to tiapride-25mg, 50mg, 100mg

For the treatments of agitation and aggressiveness in adult patients with cognitive impairment.

23.06.11

576

Tobramycin ophthalmic solution

Tobramycin sulphate ophthalmic solution-0.03% per vial.

1987-April

577

Tolterodine Tartrate Extended release tablets 2mg/4mg (Additional Dosage Form)

For the treatment of overactive bladder with symptoms of urge urinary incontinence, urinary incontinence, urgency and frequency.

31.01.14

578

Trimethyl psoralen

1965- April

579

Triphasic oral contraceptive tablets

Each tablet contains; Norgestimate, Ist day-180mcg. 2nd day-215mcg, 3rd day-250mcg, Ethinyloestradiol, 1st day-35mcg, 2nd day-35mcg, 3rd day-35mcg

29/06/1993

580

Xylometazoline

0.05% and 0.11% solution, 2-3 drops in 3-4 hrs

Nasal decongestant.

1961- March

581

Zolpidem hemitartrate

Each film coated tablet contains; zolpidem hemitartrate-5mg,10mg

Short term treatment of insominia.

28-05-1999

582

Albendazole tablet 400mg and suspension 400mg/10ml (Additional Indication)

For the treatment of systemic helminth infections 1. Neurocysticerosis 2. Echinococcosis

28.11.11

583

Exenatide Inj. (Additional Indication)

Use in patients with type-2 diabetes mellitus who are using a thiazolidinedione alone or in combination with metformibn but have not achieved adequate glycemic control.

24.05.10

584

Ibandronic acid injection

Each 1ml/2ml ampoule contains; ibandronic acid monosodium salt monohydrate eq.to 1mg/ml ibandronic acid.

By oncologists- for the treatment of tumour induced hypercalceamia with or without metastasis.

2004-May

585

Lecithin Liquid (each 5 ml contains lecithin 500mg equivalent to essential phospholipids 250mg)

Each 5ml contains; lecithin USP 500mg eq.to essential phospholipid-250mg

For the treatment of alcoholic liver disease and drug induced hepatitis.

14.05.08

586

Lercanidipine hcl

Each film coated tablet contains; lercanidipine hcl-10mg

By cardiologists- for mild to moderate hypertension.

07/05/2002

587

Levetiracetam SR Tablet 500/750/1000mg

Same as approved.

02.05.09

588

Nebivolol 5mg + S(-) Amlodipine 2.5mg Tablet

Anti-hypertensive.

14.09.2004

589

Polyethylene Glycol 400 (0.4%) + Propylene Glycol (0.3%)

Each vial contains; polyethylene glycol 400 NF-0.4% w/v, propylene glycol USP-0.3% w/v.

For temprory relief of dryness, irritation burning, stinging, grittiness or foreign body sensation caused due to environmental factors.

24/09/2007

590

Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet

Each uncoated tablet contains; telmisartan-40mg, amlodipine besylate BP eq.to amlodipine-5mg

For the treatment of essential hypertension in adults.

30/08/2006

591

Valsartan tablets

40mg, 80mg, 160mg

Additional indication; post myocardial infarction.

25/02/2005

592

Etanercept injection (25mg)

For additional indication; for treatment of adult patients with chronic moderate to severe plaque psoriasis who are candiadates of systemic therapy or phototherapy.

25/02/2005

593

Fluconazole tablet 300mg (Additional strength)

same as approved

28.11.11

594

Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation

For the maintenance treatment of asthma and for the treatment of COPD associated with chronic bronchitis.

25.05.10

595

Gemifloxacin (as msylate) 320mg tablet

Antibiotic

30/08/2006

596

Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength)

For the treatment of plaque psoriasis.

14.05.08

597

Magnesium Valporate Prolonged release tablet 600mg

I) For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. II) For prophylaxis of migraine headache in adults. III) For the treatment of manic episodes associated with bipolar disorders.

04.06.09

598

Rabeprazole Sodium 20mg + Domperidone 30mg S.R Capsule

For GERD.

04.10.2004

599

Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl. strength)

As approved.

25/09/2007

600

Vinpocetine tab

Each tab contains; vinpocetine-5mg

Psychic or neurological symptoms of cerebral circulatory disturbances of various origin e.g, impaired memory, locomoter disorder.

13/05/2002

601

Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solution)

Each textured pad contains; benzoyl peroxide treatment-4.5%, 6.5%, 8.5%

For the topical treatment of acne vulgaris.

14.05.08

602

Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection

Each vial contains; ceftazidime-500mg,1000mg, tazobactum sodium eq.to tazobactum-62.5mg,125mg

For the treatment of hospital acquired infections like nosocomial pneumonia, uncomplicated skin and skin structure infections.

30/08/2006

603

Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings

For filling any medium sized depression of the skin via mid dermis injection as well as for lip definition. The presence of lidocaine is meant to reduce the patients pain during the treatment.

28.05.10

604

Duloxetine HCl capsules

Enteric coated pellets of duloxetine-20mg, 30mg, 40mg, 60mg

For additional indication; i) for the treatment of moderate to severe stress urinary incontinence in women. Ii) for the management of neuropathic pain associated with diabetic peripheral neuropathy.

02/03/2005

605

Levocetirizine Di-HCl syrup (2.5mg/5ml) (for use in children 2 years and above)

As approved.

26/09/2007

606

Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. (Additional Strength)

For the treatment of patients with primary hypercholesterolemia.

05.12.11

607

Tenofovir Disoproxil Fumerate 300mg

For the treatment of chronic Hepatitis B in adults.

19.06.09

608

Valdecoxib

Each film coated tablet contains; valdecoxib-10mg,20mg

RMP- For treatment of osteoarthritis rheumatoid arthritis & primary dysmenorrhoea in adults only.

01/08/2002

609

Aceclofenac 1% w/w + Menthol 5% Spray

For the treatment of acute painful inflammatory conditions in adults only.

28.05.10

610

Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg

Each vial contains; cefepime Hcl USP-500mg,1000mg, tazobactum sodium eq.to tazobactum-62.5mg,125mg

For the treatment of uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections, and complicated intra abdominal infections.

30/08/2006

611

Deflazocort 24mg tablets (Additional strength)

Same as Approved.

14.05.08

612

Fluvastatin sodium sustained release (80mg) tablet

Fluvastatin sodium SR tablet-80mg

For secondary prevention of major adverse cardiac events in patients with coronary heart disease after coronary transcatheter therapy.

02/03/2005

613

Iopromide injection (Equ. To 300 & 370mg of Iodine) (Additional Indication)

for intravascular use and use in body cavities for contrast enhancement in computerised tomography (CT), Arteriography and Venography, Intravenous /Intraarterial digital substraction angiography(DSA); Intravenous urography, use of ERCP, Arthrography and EÞ¡

05.12.11

614

Lornoxicam 12 mg SR (additional strength)

Same as approved.

26.06.09

615

Metoprolol succinate SR tablets

Each tablet (SR) contains; metoprolol succinate eq.to metoprolol tartrate-25mg,50mg,100mg,200mg

By RMP- For essential hypertension & angina pectoris only.

30/10/2002

616

R-Sibutramine Capsule (2.5mg/5mg)

As an adjunctive therapy for the management of obesity including weight loss and maintenance of weight loss in pateints whose BMI is 30Kg/m2 or higher.

26/09/2007

617

Azithromycin SR Granules for oral suspension 2000mg

for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/skin structure, non gonococcal urethritis, cervicitis.

26.06.09

618

Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet

For adult patients with infection caused susceptible microorganisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis.

27/09/2007

619

Imatinib mesylate (gamma crystalline)

Each film coated tablet contains; imatinib mesylate eq.to (gamma crystal form) imatinib-100mg

By oncologists only- for treatment of CML in blast crisis, accelerated phase or in chronic phase after failure of interferon alpha therapy.

26/02/2005

620

Levocetrizine tablets

Each film coated tablet contains; levocetrizine 2hcl-5mg

RMP- for treatment of allergic rhinitis & chronic urticaria.

12/12/2002

621

Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets

As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control.

28.05.10

622

Micafungin sodium for Injection 10mg per vial/50mg per vial (Additional Indication)

1) Prophylaxis of Aspergillus Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation. 2) Treatment of Patients with Fungemia, Respiratory mucosis, Gastrointestinal mycosis caused by Aspergillus sp.

05.12.11

623

Paromomycin Inj. 375mg/ml

Each ml contains; paromomycin sulphate eq.to paromomycin-375mg

For the treatment of visceral leishmaniasis (Kalaazar).

31/08/2006

624

Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection (additional strength)

For use as a surgical aid in anterior segments procedure including catract extraction & intra-ocular lens implantation.

14.05.08

625

3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack

Additional strength

28.05.10

626

Artemether + Lumifantrine

Each tablet contains; artemether-20mg, lumefantrine-120mg

For hospital use only- for treatment of p.falciparum malaria cases resistant to both chloroquine and sulphadoxine pyrimethamine combination.

26/12/2002

627

Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab.

Antibiotic

31/08/2006

628

Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets

For the treatment of GERD, gastric and duodenal ulcer, Zollinger-Ellison syndrome.

14.05.08

629

Fluconazole 400mg tablet

400mg

Additional indication; pityriasis versicolor.

03/03/2005

630

Metoprolol 50/50/25 mg + Atorvastatin20/10/10 mg + Ramipril 10/5/2.5 mg capsules

As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive with lipid lowering agent.

01.07.09

631

Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml)

For diagnostic use in echocardiography doppler of macrovasculature an doppler of microvasculature.

28/09/2007

632

Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets

For the treatment of Patients with acute muscle/musculoskeletal spasm in adult.

07.12.11

633

Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg

For anxiety

20/09/2006

634

Calcium carbonate 600mg + Simethicone 80mg Chewable tablet

To relive the uncomfortable symptoms of acid indigestion, heart burn, gas or sour stomach.

28.05.10

635

Fluticasone propionate (125mg/250mg) + Salmeterol (as xinafoate) (50mcg) metered dose inhaler

Fluticasone propionate-125mg, 250mg + Salmeterol (as xinafoate)-50mcg

Additional indication; chronic obstructive pulmonary disease .

2005-March

636

Methyl Phenidate ER Tablet 10/20/30mg

For the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

10.07.09

637

Mycophenolate sodium

Each tablet contains; mycophenolate sodium-180mg,360mg.

For the prophylaxis of acute organ rejection and for the treatment of refractory organ rejection in patients receiving allogeneic renal transplants increased graft and patients survival receiving allogeneic cardiac transplants and used concomitantly with Þ¡

05/12/2002

638

Ondansetron orally disintegrating tablet (4mg/8mg) (additional dosage form)

Each oral disintegrating tablet contains; ondansetron-4mg, 8mg

For chemotherapy induced nausea and vomiting.

10/10/2007

639

Paracetamol IP 325mg + Pamabrom USP 25mg Tablets

For the treatment of patient with premenstrual syndrome in adults only.

07.12.11

640

Telmisartan 40mg + Atorvastatin (as calcium) 10mg Tablets

For coexisting essential hypertension & hyperlipidemia.

22.05.08

641

3 chamber bags of glucose solution, amino acid solution & fat emulsion for .v infusion

By RMP- for parenteral nutritions where oral or enteral nutrition is impossible or impracticable.

2005-March

642

Activated Dimethicone 50mg + Magnesium Hydroxide 250mg + Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution

For treatment of symptoms of hyperacidity (e.g. heartburn, epigastric discomfort, or their equivalents) that are often associated with dyspepsia, peptic ulcers, gastritis, peptic esophagitis and indicated for relief of flatulence.

28.05.10

643

Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet

For UTI, URTI and LRTI and gonococcal urethritis.

05/10/2007

644

Dasatinib Tablets 100mg (addl. Strength)

Same as approved.

10.07.09

645

Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets

For the treatment of neuropathic pain.

08.12.11

646

Epinastine Hcl (0.05%) Opthlamic solution

For allergic conjunctivitis.

22/09/2006

647

Mesalazine SR

Bowel disease (Inflammatory)

04/04/2002

648

Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet

Each capsule contains; milnacipran Hcl- 25mg, 50mg eq.to milnacipran free base 21.77mg or 43.55mg respectively

For the treatment of adult patients with major depressive disorder.

22.05.08

649

Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg Tablets

For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate.

01.06.10

650

Cefuroxime-125/250/500mg + Clav.Acid-31.25/62.5/125mg

For adult patients with infection caused by susceptible microbs,including s.aureus. (e.g-UTI,Upper&lower RTI & gonococcal urethrities)

05/10/2007

651

Cefuroxime Sodium 250mg intramammay infusion for Veterinary (PFS) (New dosage form)

For the treatment of Clinical mastitis in milking cows.

13.12.11

652

Doxorubicin Hcl liposomal injection

2mg/ml

For additional indication; in the treatment of metastatic breast cancer, where there is an increased cardiac risk.

2005-April

653

Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication)

Additional indication; in treatment of prostatitis.

21/09/2006

654

Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets

For hypertension in patients whose blood pressure is not adequately controlled in monotherapy.

28.05.08

655

Moxifloxacin intravenous infusion

Each 100ml infusion contains; moxifloxacin Hcl eq.to moxifloxacin-400mg

Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia & uncomplicated skin & skin structure infection in adults of age 18 years & above.

13/02/2002

656

Voglibose 0.2 mg + Metformin 500mg Tablets

As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control.

13.07.09

657

Amiodarone Injection (additional Indication)

For cardiopulmonary resuscitation in the event of cardiac arrest related to ventricular fibrilation resistant to external electric shock.

05/10/2007

658

Carmustine for inj. 100 mg

Indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Þ¡

10.06.10

659

Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine

A. combipack of 1 stip of 3 tablets ofartesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg + pyrimethamine 6.25mg B. combipack of 1 stip of 3 tablets ofartesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg + pyrimethamine 25mg C. coÞ¡

For the treatment of P. falciparum resistant malaria patients.

15.07.09

660

Feracrylum 1% mouth gargle 10mg/ml

As haemostatic agent in dental surgery.

28/09/2006

661

Fludarabine injection & tablet (100mg)

100mg

For additional indication; for the treatment of V-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow, first time treatment with fludarabine oral should only be initiated in patients with adv.disease rai stages III/IV (Binet sÞ¡

2005-April

662

Metolazone 2.5mg + Ramipril 2.5mg/5mg

For essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy.

28.05.08

663

Minoxidil Topical Solution 5%

Each ml contains; minoxidil 50mg

Indicated in treatment of alopecia (male pattern baldness) in men.

16/05/2002

664

Montelukast Sodium IP eq.to Montelukast 10mg + Olopatadine Hcl 5mg Tablets

For the treatment of relief of symptoms of allergic rhinitis.

16.12.11

665

Lincomycin Hcl + Lincomycin base

Each 5mL contains; Lincomycin Hcl eq. to Lincomycin base-250mg

1973-June

666

Amoxycillin + Clavulanic acid injections

600mg vial-each contains; amoxycillin-500mg, clavulanic acid-100mg, 1.2gm vials-each contains; amoxycillin-1g, clavulanic acid-200mg

1987-May

667

Aspirin + dipyridamole ER cap

Each hard gelatin cap contains; aspirin IP-25mg, Dipyridamole BP-200mg (ER)

For reduction of risk of stroke in patients who had transient ischemia of the brain of complete ischemic stroke due to thrombosis.

27-02-2003

668

Atazanavir 300mg capsules (Additional strength)

Same as approved.

08.01.08

669

Atenolol + Amlodipine besylate tabs

Each uncoated tab contains; amlodipine besylate eq.to amlodipine-5mg, atenolol-50mg

20/05/1996

670

Bortezomib for injection 3.5mg (Subcutaneous route of administration as an alternate to intravenous route) (Additional route of administration)

Same as already approved

28.01.14

671

Capecitabine tablets (already approved)

For additional indication; first line treatment in patients with metastatic colorectal carcinoma

14-03-2001

672

Cetrizine dihydrochloride tablets

Each film coated tablet contains; cetrizine dihydrochloride-20mg (appr 2-8-96), 10mg & 5mg(22-5-96), cetrizine DHC syrup-10mg/10ml & cetrizine DHC drops-10mg/ml (appr 30-6-94, cipla)

Seasonal rhinitis and conjuctivitis, perannual allergic rhinitis, pruritis and urticaria.

25/06/1993

673

Ciprofloxacin tablets

Each tablet contains; ciprofloxacin hcl monohydrate eq.to 250mg,500mg,750 ciprofloxacin,

Antibacterial- Indicated in the treatment of respiratory tract infection, UTI, skin & soft tissue, severe systemic infections, surgical, gynae, G.I, bone & joint infections, STD.

1989-May

674

Clarithromycin tablets

Each tablet contains; clarithromycin-250mg,500mg, (Clarithromycin paediatric suspension)-each ml contans; clarithromycin-125mg,250mg (4-9-95)

Of mild to moderately severe infections like acute exacerbation of chronic bronchitis community acquired pneumonia including infections due to chlamydia, mycoplasma spegiocella acute streptococcal pharyngitis and skin and soft tissue infections.

22/03/1995

675

Colesevelam Hydrochloride Tablets 625mg & Sachets for oral suspension 3.75gm/1.875gm.

Each film coated tablet contains; colesevelam hydrochloride-625mg, Each sachet contains; colesevelam hydrochloride-3.75gm, 1.875gm

Indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (staÞ¡

29.08.2012

676

Dexfenfluramine hcl. Capsules

Each capsule contains; dexfenfluramine hcl 15mg.

Anti obesity drug- Indicated in association with diet in the treatment of uncomplicated obesity, complicated obesity in adults, of refractory obesity, and of obesity involving disorders of dietary behaviour (carbohydrate compulsion).

22/06/1992

677

Diclofenac Colestyramine 145.6mg Capsule Corresponding to Diclofenac Sodium 75mg (Additional Indication)

For the treatment of post-traumatic or post-operative swelling and inflammation.

25.02.13

678

Disodium Cromoglycate

Disodium Cromoglycate-2%

1976-September

679

d-Norgestrel + Ehinyloestradiol

Each tablet contains; d-Norgestrel-0.15mg, Ehinyloestradiol-0.03mg

1974- August

680

Eletriptan Hydrobromide Tablets 20mg/40mg

Each uncoated tablet contains; eletriptan hydrochloride eq.to eletriptan-20mg, 40mg

For the treatments of Migraine with or without aura in adults

25.08.11

681

Ethamsylate tablets

Each tablet contains; ethamsylate-250mg,500mg

Anti haemostatic- Indicated in the treatment of small vessel haemorrhage menorrhagia (including IUD users) prophylaxis of periventricular haemorrhage in neonates.

1988-May

682

Etoricoxib tablets

2004-March

683

Fenticonazole Nitrate Bulk & Vaginal Capsule 600 mg

Each soft gelatin vaginal capsule contains; fenticonazole nitrate ph eur-600mg, excipients-q.s, approved colors used in capsule shell

For the treatment of vulvovaginal candidiasis.

10.08.16

684

Fluconazole + Secnidazole + Azithromycin

Each combikit contains; i)-Uncoated tablet of one Fluconazole-150mg, ii)-one tablet of azithromycin dihydrate eq.to azithromycin-1gm, iii)-two film coated tablet of secnidazole-1gm

07/06/1999

685

Hydrotalcite

Each tablet/suspension 5ml contains; hydrotalcite-500mg, simethicone (activated)-125mg

Antacid- Indicated in the treatment of flatulance, hyperacidity, gastritis, heart burn, dyspepsia etc.

1986-June

686

Ibrutinib 140mg Hard gelatin Capsule

Each capsule contains; ibrutinib-140mg

For the treatment of adult patients with:-mantle cell lymphoma (MCL) who have recieved at least one prior therapy.-Chronic Lymphocytic leukemia (CLL) who have recieved at least one prior therapy.- Chronic lymphocytic leukemia with 17p deletion.

07.10.15

687

Ibuprofen

Each tablet contains; ibuprofen-200 mg.

1971- September

688

Inactivated Rabies Vaccine (Human diploid cell)

Antirabies- For the treatment of rabies.

1981-April

689

Isoxsuprine Hcl

Each sustained release tablet contains; Isoxsuprine Hcl eq to 40mg of Isoxsuprine

1979-May

690

Lamotrigine tablets

Each scored tablet contains; lamotrigine-25mg

Add on therapy for partial and secondry generalised tonic-clonic seizures in adults not below 16 years of age.

14/05/1998

691

Levodropropizine oral syrup (30mg/5ml)

Each 5ml contains; levodropropizine Hcl-30mg

By RMP- Symptomatic treatment of non-productive cough in adults.

25/02/2005

692

Measles virus vaccine live attenuated

Prophylactic

1965- April

693

Medrysone

Medrysone USP-1%

1980-July

694

Methdilazine

8mg, thrice daily.

New long acting Antihistaminic-

1961- March

695

Methohexital sodium

500mg amp, 12.5 g vials

Anesthetic (ultra short).

1964- April

696

Mometasone furoate + terbinafine hcl cream

Each 5gm contains; mometasone furoate-0.1% w/w, terbinafine hcl-1%w/w

Topical fungal infection associated with inflammation & pruritis.

16-01-2002

697

Naproxen topical gel 10%

Naproxen gel contains; naproxen-10% w/w

31/08/1994

698

Netilmicin sulphate injection

Each ml contains; netilmicin sulphate eq.to 10mg,25mg,100mg of netilmicin, also 50mg/ml (vide letter 21-6-90)

Aminoglycoside antibiotic- Indicated in the treatment of septicaemia including neonatal sepsis and other severe systemic infections.

1985-August

699

Oxytetracycline

250mg

Palmar abscess, gangrene, appendicular abscess.

1967- June

700

Pamabrom

50 mg

Diuretics.

1962- April

701

Paracetamol + Chlormezanone

Each tablet contains; paracetamol-450mg, chlormezanone-100mg

1982-October

702

Pinaverium bromide

Each film coated tablet contains; pinaverium bromide-50 mg

In the treatment of spastic colon, irritable bowel syndrome, billiary dyskinesia and for radiological investigation.

1990- April

703

Polyvidone eye drops 5%

Each ml contains; polyvidone-50mg

Symptomatic treatment of dry eye conditions including kerato-conjunctivitissicca.

30/04/1997

704

Polyvinyl pyrrolidone iodine

Antiseptic/Germicidal.

1970- September

705

Roxatidine acetate hcl

Each SR Tablet contains; roxatidine acetate hcl-75mg

Anti ulcer- Disorders in the upper gastric intestinal region i.e duodenal ulcer, benign gastric ulcers.

1991- May

706

Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v

Each gram of powder/lotion contains; sertaconazole nitrate-20mg

For the topical treatment of the superficial fungal infections of the skin.

05.05.09

707

Sodium Fluoride B.P.

Each enteric coated tablet contains; Sodium Fluoride B.P.-20mg

ENT Specialists only

1975-August

708

Sulphinpyrazone

Each tablet contains; 100mg of Sulphinpyrazone, Each capsule contains; 200mg of Sulphinpyrazone

1977-September

709

Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injection

For testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism.

08.02.07

710

Theophylline Ethanoate of Piperazine

Each tablet contain Theophylline Ethanoate of Piperazine - 0.25gm, Each mL contain Theophylline Ethanoate of Piperazine-0.125gm

1972- November

711

Ticlopidine

Addional indication prevention of subacute occlusion following coronary stent implantation.

03/03/2000

712

TroxipideÂ film coated Tablets 50mg /100mg

Each film coated tablet contains; troxipide-50mg, 100mg

For the treatment of Gastric ulcers and for amelioration of gastric mucosal lesions (erosion, hemorrhage, redness and edema) in the diseases such as acute gastritis, acute exacerbation stage of chronic gastritis.Â

20.05.10

713

Zanamavir inhalation powder 5mg/blister

For influenzae.

13/02/2006

714

Zinc Sulphate IP

Each capsule contains; Zinc Sulphate IP-200mg

1978-September

715

Aceclofenac Inj. (150mg/ml)

For pain in post operative & post traumatic cases.

28/09/2006

716

Dalteparin sodium injection

For additional indication; for prophylaxis of deep vein thrombosis in medical patients who are at risk of thromboembolic complication due to severely restricted mobility during acute illness subject to all other conditions, statements of initial approvalsÞ¡

02/05/2005

717

Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules

Each soft gelatin capsule contains; doxercalciferol- 0.5mcg, 2.5mcg.

For the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

29.05.08

718

Luliconazole lotion 1 % W/V (new Dosage Form)

Same as approved

19.12.11

719

Milnacipran 100mg (additional Strength)

Same as approved.

16.07.09

720

Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast Sodium Oral granule (Additional indication)

For the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.

12.06.10

721

Risedronate Sodium tablet (35mg) (additional indication)

For osteoporosis in men at high risk of fracture.

08/10/2007

722

Acebrophylline capsules 100mg

Each capsule contains; acebrophylline- 100mg

For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.

29.05.08

723

combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack)

As Approved.

10/10/2006

724

Diacerin

19/05/2005

725

Etizolam CR Tablets 1.5 mg/3 mg (modified Dosage Form)

Same as approved

19.12.11

726

Ramosetron Dispersible Tablet 0.1mg

For the prevention and treatment of gastrointestinal symptoms (nausea and vomitting) associated with ematogenic cancer chemotherapy.

12.06.10

727

Rifaximin 400mg (additional Indication)

For the treatment of hepatic encephalopathy.

18.07.09

728

Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment

For infected wounds and ulcers.

09/10/2007

729

Tetrahydro furfuryl salicylate + Ethyl nicotenate + n-Hexyl nicotinate

Antirheumatic.

1963- July

730

Amitraz 2%w/v pour on solution

For the control of ticks on cattle and ostriches.

12.06.10

731

Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 8mg Tablets. (Additional Strength).

For the treatment of mild to moderate hypertension in adults only and or treatment of stable coronary artery disease in patients already controlled with Perindopril & Amlodipine given concurrently at same dose level.

20.12.11

732

Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg /250mcg MDI

For Asthma & COPD

14/10/2006

733

Levetiracetam Tablet (addl. indication)

(i) As monotherapy in partial onset seizures with or without secondary generalisation in patients with 16 years of age with newly diagnosed epilepsy. (ii) As adjunctive therapy in myoclonic seizures in adults and adolescents from 12 years of age with JuveÞ¡

09/10/2007

734

Nevirapine tablet 50 mg for oral suspension mg

For the treatment of HIV infection in combination with other anti retro viral agents.

18.07.09

735

Sapindus saponin (Reetha saponin) cream

2005-May

736

Sofalcone Capsule (100mg/50mg)

Each capsule contains; sofalcone-50mg, 100mg.

For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute exacerbation of chronic gastritis.

02.06.08

737

Amlodipine 25mg + Metoprolol 25mg (additional lower strength)

01/11/2006

738

Atorvastatin calcium (amorphous)

27/05/2005

739

Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form)

Same as approved.

18.07.09

740

Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) each

For drug resistant malaria.

10/10/2007

741

Lidocaine Patch 350mg (Additional Pack Size)

For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

17.06.10

742

Posaconazole oral suspension 40 mg/ml (additional Indication)

Zygomycosis in patients with disease refractory to other therapy, or patients who are intolerant of other therapy.

20.12.11

743

S(+) Etodolac ER tablets 200mg/300mg

Each ER film coated tablet contains; S(+) etodolac- 200mg, 300mg.

For the relief of pain and inflammation in patients with rheumatoid arthritis and osteoarthritis.

02.06.08

744

Amphotericin B Emulsion 5mg/ml (Addl. Indication)

Febrile Neutropenia in cancer patients.

18.07.09

745

Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets

For the treatment of adult patients with signs & symptoms of acute painful conditions.

02.06.08

746

Estrogen vaginal tablet 25mcg

For atropic viginitis.

02/11/2006

747

Everolimus Tablet 5 mg/10 mg (additional Indication)

Indication for the treatment of progressive neuroendocrine tumours of pancreatic origin (PNET) in patient with unrespectable, locally advanced or metastatic disease.

21.12.11

748

Nifedipine gel (2% w/w)

Each gm of gel contains; nifedipine-2mg

For the treatment of acute & chronic anal fissures.

2005-May

749

Oseltamivir Phosphate (Additional indication)

In the treatment of children 6 to 12 months of age during a pandemic influenza outbreak.

19.06.10

750

Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 900mg per 20ml

For breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

11/10/2007

751

Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules

For GERD.

13/11/2006

752

Hydroxy ethyl starch 10% Solution for infusion

For the treatment of imminent or manifest hypovolemia and shock.

18.07.09

753

Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg + Zinc Picolinate (26mg) eq. To elemental zinc 5.5mg syrup

For the treatment of Iron Deficiency Anaemia.

22.12.11

754

Methylcobalamin 1500mcg + Folic acid 0.7mg +Niacinamide 12mg injection

For the treatment of diabetic neuropathy in adults.

23.06.10

755

Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet

For mild to moderate hypertension.

15/10/2007

756

Sodium Hyaluronate injectable gel (Each 0.6ml, 1ml pre filled syringe contains; sodium Hyaluronate 20mg/ml, 22.5mg/ml)

Each 0.6ml, 1ml pre filled syringe contains; sodium Hyaluronate 20mg/ml, 22.5mg/ml

For intradermal implantation and facial soft tissue augmentation.

03.06.08

757

Temoporfin i.v injection

Each ml of i.v infusion contains; temoporfin-2mg

Oncologist only.

2005-May

758

Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension

For invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin B therapy.

03.06.08

759

Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet

For treatment of patients with both hypertension and hypercholesterolemia.

15/10/2007

760

Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength)

Antibiotic

14/11/2006

761

Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU (additional Strength)

Same as approved.

20.07.09

762

Levetiracetam (1000mg) tablet

Additional strength

2005-May

763

Methylcobalamin 1500mcg + Pyridoxine 100mg + Nicotinamide 100mg injection

For the treatment of diabetic neuropathy in adults.

23.06.10

764

Piroxicam sublingual tablet 20mg (Additional dosage form)

In the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervical spondylitis and other musculoskeletal disorder.

27.12.11

765

1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of Nevirapine 200mg combipack

For the treatment of HIV infection in adults.

23.06.10

766

Cefixime dispersible tablet 400mg (new dosage Form)

Antibiotic.

22/11/2006

767

Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules

For the treatment of Gastroeasophageal Reflux Disease (GERD) in patients not responding to dexrabeprazole alone.

09.06.08

768

Ofloxacin eye drops (3mg/ml)

3mg/ml

For addditional indication; for the topical treatment of external infection of eyes in adults & children above 1 year.

14/06/2005

769

Omeprazole(20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength)

As approved.

15/10/2007

770

Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules

For secondary prevention of coronoryheart disease/stroke in patients where use of such combination is appropriate.

21.07.09

771

Zoledronic acid 4mg/100ml ready to use (RTU) solution for i.v infusion (Additional dosage form)

Treatment of: 1. Hypercalcemia of malignancy. 2. Patient with myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

27.12.11

772

Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU

Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis.

28.07.09

773

Everolimus Tablet 5 mg/10 mg (additional Indication)

Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis.

27.12.11

774

Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg) per ml. (eye drops)

For inflammation after ocular surgery and where a risk of bacterial ocular infection exists.

16/10/2007

775

Temoporfin solution for injection

Each ml contains; temoporfin-4mg

For the palliative treatment of patients with advanced head & neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy surgery or systemic chemotherapy.

14/06/2005

776

Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets

For acute low back pain & other musculoskeletal painful and inflammatory condition in adults.

11.06.08

777

Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg /240mg/180mg

Anti hypertensive.

23/11/2006

778

Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mgÞ¡

For the treatment of vitamin deficiency states in adults.

23.06.10

779

Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication)

For the treatment of lower respiratory tract infection in children.

24.06.08

780

Ciclesonide 160mcg/320mcg cap. for inhalation

Anti asthmatic.

28/11/2006

781

Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate (200mg) tablet

For diabetic neuropathy.

16/10/2007

782

Oxaceprol capsules 200mg

For the relief of signs and symptoms of osteoarthritis in adult patients.

15.03.11

783

Ramipril MR capsule 10mg

For the treatment of hypertension/ cardiac failure and myocardial infarction.

30.07.09

784

Ramipril MR Capsules 2.5/5 mg (Additional Strength)

Same As Approved

03.07.10

785

Sodium hyaluronate eye drops (0.18 w/v)

Each ml contains; sodium hyaluronate-1.8mg

For the treatment sensation of ocular dryness, and other minor complaints of no pathological significance viz., burning & ocular fatigue induced for example by dust, smoke, dry atmosphere, air conditioning, extended computer screen use or contact lens weaÞ¡

21/06/2005

786

Alphachymotrypsin + ethyl nicotinate

Each 20g contains; alpha chymotrypsin-60mg, ethyl nicotinate-200mg

1971- September

787

Ambrisentan film coated Tablets 5 mg / 10mg

Each film coated tablet contains; ambrisentan-5mg, 10mg

For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.

28.05.10

788

Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial

Each vial contains; bendamustine Hcl-100mg

For the treatment of patients with chronic lymphocytic leukemia.

19.05.09

789

Benzoyl peroxide + Precipitated sulphur

Each 20 gm contains; Benzoyl peroxide-10%w/w, Precipitated sulphur-5% w/w

1975-August

790

Candur P. Parvovirus vaccine

Inactivated cannine parvovirus

Indicated in active immunization of dogs against parvovirus infection.

09/07/1992

791

Cefotaxime injection

Cefotaxime-0.25gm,0.5gm,1gm and 2gm

Antibiotic- Indicated in the treatment of patients with serious infections.

1987-June

792

Chlorpromazine + Trifluoperazine + Trihexy phenidyl

Each tablet contains; Chlorpromazine-50mg, Trifluoperazine-5mg, Trihexy phenidyl-2mg

Schedule C

1979-May

793

Ciprofloxacin infusion

Each 50ml bottle contains; ciprofloxacin lactate eq.to 100mg ciprofloxacin, Each 100ml bottle contains; ciprofloxacin lactate eq.to 200mg ciprofloxacin

1989-May

794

Clofazemine

50 & 100 mg

Anti-leprosy drug.

1969- September

795

Codeine phosphate 10mg + triprolidine hcl 1.25mg

Codeine phosphate-10mg, triprolidine hcl-1.25mg per 5/ml syrup

For symptomatic treatment of dry cough

18-02-2003

796

Cosumix plus

Each 100 gm cosumix plus powder contains; alpha chloropyridazine sodium-10g, methoprin-2gm

1990- May

797

Cumophos 50%

05/07/1993

798

Dexamethasone sodium metasulphobenzoate

Corticosteroid, anti-inflammatory.

1962- April

799

Doxorubicin injection

Each vial contains; doxorubicin hydrochloride-10mg

1986-July

800

Duloxetine HCl (60mg) tablet (additional strength)

28/02/2005

801

Ertapenem for injection 1gm/vial (additional indication)

For the prophylaxis of surgical site infections following elective colorectal surgery.

15.01.08

802

Esmolol hcl inj.

Each 10ml ampoule contains; 2.5gm of esmolol hcl, Each 10ml vial contains; 100mg of esmolol hcl

Supraventricular tachycardia for rapid control of ventricular rates patients with atrial fibrillation or artrial flutter in perioperative, post-operative circumstances where short term control of ventricular rate is desirable.

26/08/1994

803

Felodipine

Each ER film coated Tablet contains; felodipine-5mg,10mg.

Anti hypertensive- In the treatment of hypertension.

1991- May

804

Glutathione for Injection 600mg

Each vial contains; glutathione-600mg

For the treatment of alcoholic liver diseases like alcoholic fatty liver, alcoholic liver fibrosis, alcoholic liver cirrhosis, and hepatitis

14.09.11

805

Human placental Extract

1978-September

806

Isoxsuprine

10mg

Peripheral vasodilator.

1961- March

807

Lacidipine tablets

Each film coated tablet contains; lacidipine-2mg,4mg

Mild to moderate hypertension.

06-05-1997 to 05-05-1999

808

Ledipasvir (90mg) + Sofosbuvir (400mg) tablets

Each film coated tablet contains; ledipasvir-90mg, sofosbuvir-400mg

For the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.

08.12.15

809

Letrozole

2.5mg

For first line therapy in post menopausal women with Advanced Breast cancer

11/02/2002

810

Losartan potassium + Hydrochlorothiazide

Each film coated tab contains; Losartan potassium-50mg, Hydrochlorthiazide-12.5mg

08/06/1999

811

Magestrol acetate

4mg tab+0.05 ethionyl estradiol

Progestational

1964- April

812

Megaldrate tablets/Chewable/Suspension

Tablet (megaldrate-400mg), Chewable(megaldrate-400mg, simethicone-60mg), Suspension (megaldrate-400mg, simethicone-60mg per 5ml)

1982-November

813

Methophenazine

Tranquiliser (Major)

1965- April

814

Microgynen

1974- November

815

Minocycline tablets/capsules/oral suspension

Tablets/capsule-minocycline-100mg, oral suspension-minocycline-50mg

Antibiotic- Indicated in the treatment of UTI, respiratory, Skin & soft tissue, ENT infections, rockettsial, pneumonia, gonorrhea, uncomplicated urethral, endoservical or rectal infections, STD, anarobic infections meningitis.

1988-May

816

N-butyl cyano acrylate bioadhesive (liquid adhesive)

N-butyl cyanoacrylate-0.5ml

For treatment of smooth and fresh skin wounds and surgical incision.

06/06/1996

817

Nevirapine

Each tablet contains; nevirapine-200mg, Each 5ml of suspension contains; nevirapine-50mg

For HIV infection in combination with other anti retroviral agents.

06/03/2000

818

Paclitaxel Injection Concentrate for Nanodispersion 100mg and 300mg (Additional Dosage Form)

For the treatment of Breast cancer after failure of combination therapy metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

22.01.14

819

Palbociclib Capsules 75mg/100mg/125 mg

Each hard gelatin capsule contains; palbociclib 75mg, 100mg and 125mg

Palbociclib is a kinase inhibitor indicated in combination with Letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-Positive, human epidermal growth factor receptor 2 (HER2)-Negative advanced breast cancer as initial endocrine-Þ¡

11.08.16

820

Podophyllotoxin topical solution

Each 3-5ml contains; podophyllotoxin-0.5%

Anogenital warts, non genital warts only

05/05/1995

821

Povidone Iodine

i) Betadine solution containing-10% Povidone Iodine, ii)Betadine gargle containing-0.5% of Povidone iodine, iii)Betadine ointment containing-10% Povidone iodine.

1972- November

822

Prednisolone stearoylglycolate

Corticosteroid

1970- November

823

Prenylamine Lactate

Prenylamine Lactate-60mg

1973-June

824

Propofol inj.

Each ml contains; propofol 10mg in vehicle containing soybeen oil and purified egg lecithin and glycerol.

Induction and maintenance of general anaesthesia.

18/05/1998

825

PVP/VA Resin + Benzalkonium Chloride + Lignocaine Hcl + D-anthanol DAB-700R

Each aerosol pack of 85gm PVP/VA Resin-5%, Benzalkonium Chloride-0.10%, Lignocaine Hcl-0.25%, D-anthanol DAB-7DDR-2%

1977-September

826

Ranitidine tablets

Each tablet contains; ranitidine hcl eq.to 150 mg of ranitidine.

Anti ulcer- Indicated in the treatment of duodenal ulcer, benign gastric ulcer, post operative ulcer, reflux oesophagitis, zollinger ellison syndrome.

1985-August

827

Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional strength)

As approved

08.02.07

828

Sisomicin sulfate

Aminoglycoside antibiotic- Indicated in the treatment of the systemic and local infections of the kidney, genitourinary tract, lower respiratory tract infections, septicemia, soft tissue infections, gastrointestinal tract infections, infections of the CNSÞ¡

1981-April

829

Sodium hyaluronate solution

Sodium hyaluronate 5000 - 23mg/ml in disposable syringes.

By RMP- surgery in the anterior segment of the eye.

07/03/2001

830

Sulthiame

200 mg tabs

Anti-convulsant, in the treatment of partial seizure especially psycho-motor or temporal epilepsy, rhininencepholic and diencephalic seizures also well controlled

1967- June

831

Tadalafil Tablet 2.5mg/5mg

2.5mg, 5mg

1.For the treatment of erectile dysfunction. 2. For the treatment of erectile dysfunction with benign prostatic hyperplasia.

27.02.13

832

Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength)

For replacement therapy in males with Testosterone deficiency.

15/02/2006

833

Thiocolchicoside injection

Each 2ml ampoule contains; thiocolchicoside-4mg

RMP- as an adjuvant treatment in painful spasm associated with degenerative vertebral disorders and vertebral static problem, torticollis dorsal pain, low back pain, traumatological and neurological disorders.

25/03/2004

834

Tolvaptan Tablets 15/30mg

Each uncoated contains; tolvaptan-15mg, 30mg

For the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirhosÞ¡

06.09.2012

835

Trimethoprim + Sulphamethoxazole

Each 5mL ampule contains; Trimethoprim-80mg, Sulphamethoxazole-400mg

For hospitals

1976-October

836

Trypsin + chymotrypsin

Each mL contains; 10,000 Armour units of proteolytic activity of both Trypsin and chymotrypsin

1980-July

837

Abacavir Sulfate Tablet 60mg

For the treatment of HIV-1 infection in combination with other antiretroviral agents.

01.08.09

838

Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength)

Same as Approved.

24.06.08

839

Docetaxel injection (shelf life extension)

24 months from 18 months for 20mg/0.5ml, 36 months from 24 months for 80mg/2ml

2005

840

Oxaceprol Bulk

Bulk

15.03.11

841

Rabeprazole 20mg (EC) + Itopride SR 150mg

For GERD.

28/11/2006

842

Satranidazole (300mg) + Ofloxacin (200mg) Tablet

For diarrhoea of mixed infection in adults.

18/10/2007

843

Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication)

(i) Use of Sitagliptin Phosphate in combination with Metformin and a PPARÎ³ agonist as an adjunct to diet & exercise in adult patients with type-2 Diabetes mellitus who are inadequately controlled on combination therapy with Metformin and a PPARÎ³ agonist. Þ¡

03.07.10

844

Erlotinib HCl 25/100 mg Tablet (Additional Indication)

As monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum based first line chemotherapy.

03.07.10

845

Mecobalamin 0.5mg + Alpha Lipoic Acid 100mg + Benfotiamin100mg + Pyridoxine 50mg tablets

For the treatment of diabetic neuropathy.

03.07.08

846

Methylcobalamin 500mcg + beta carotine 10.33mg + alpha lipoic acid 100mg + B6 1.5mg + B1 2mg & Cr.polynicotinate

For adult patients with diabetic neuropathy.

18/10/2007

847

Metoprolol succinate 25mg /50mg ER + Hydrochlorthiazide 12.5mg

Anti hypertensive.

30/11/2006

848

Nadifloxacin (1%) powder

Each gm of powder contains; nadifloxacin-10mg

For superficial localised bacterial skin infection.

18/07/2005

849

Zoledronic Acid Solution for Infusion Addl. Indication

Prevention of clinical fractures after hip fracture in men and women.

01.08.09

850

Atorvastatin 5mg + Fenofibrate 160mg (additional strength)

As Approved.

01/12/2006

851

Calcium Pidolate equivalent to Calcium 500mg + Vit-D3250 IU

For osteoporosis and calcium deficiency state.

23/10/2007

852

Gemcitabine HCl injection 2gm/vial (Additional Strength)

Same As Approved

03.07.10

853

Ivabradine (Hcl.) 5mg/7.5mg Tablets

Each film coated tablet contains; ivabradine Hcl eq.to ivabradine-5mg, 7.5mg

For the treatment of chronic stable angina pectoris in patients with normal sinus rhythm who have a contraindication or intolerance for Beta-blockers.

03.07.08

854

Methylcobalamine 1500mcg oral tablets

Each ER tablet contains; mecobalamine JP-1500mcg

For peripheral neuropathies and megaloblastic anaemia caused by vitamin B12 deficiency.

21/07/2005

855

Sumatriptan 85 mg + Naproxen 500 mg Tablets

Additional Strength for the treatment of migraine.

03.08.09

856

Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets

For the treatment of acute inflammation conditions associated with spasm in adults only.

03.08.09

857

Aceclofenac Inj. 50mg/ml (additional strength)

As Approved.

01/12/2006

858

Budesonide enema

Each tablet for enema contains; budesonide-2.3mg

For the treatment of ulcerative colitis involving rectal & rectosigmoid diseases.

05/08/2005

859

Etizolam 0.25 mg tablet (Additional Strength)

Same As Approved

03.07.10

860

Etizolam Tablet (0.5mg/1mg)

Each film coated tablet contains; etizolam-0.5mg, 1mg

For generalised anxiety disorder associated with depression.

30.10.07

861

Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule

For the treatment of diabetic Neuropathy.

04.07.08

862

Aceclofenac(100mg) + Thiocolchicoside (4 mg) tablets (Additional strength)

For the treatment of acute inflammation conditions associated with spasm in adults only.

11.08.09

863

Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion)

Indicated to meet daily requirement of nitrogen (amino acids), energy (glucose) for patients needing parentral nutrition.

08.07.08

864

Amisulpride 400mg tablet (additional strength)

As Approved.

01/12/2006

865

Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg)

For the topical treatment of acute musculoskeletal pain.

06.07.10

866

Donepezil (for additional indication)

For symptomatic improvement of vascular dementia (with cardiovascular diseases).

10/08/2005

867

Oxaprozine Tablet (600mg)

Each film coated tablet contains; oxaprozin-600mg

For the management of pain and inflammation in adult patients with osteoarthritis & rheumatoid arthritis.

30/10/2007

868

Cefuroxime Sodium 750/1500mg + Sulbactam Sodium 375/750mg

For the treatment of mild to moderate lower respiratory tract infection.

06.07.10

869

Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication)

For cervical ripening, prevention of post partum haemorrhage & First trimester of aboration with mifepristone.

08/12/2006

870

Octreotide long acting release injection

Octreotide long acting release injection with needles & solvent in prefilled syringes each containing octreotide free peptide-10mg, 20mg, 30mg

2005-August

871

Oxcarbazepine 150/300/600mg Tablet (Addl. Indication)

Treatment of generalized tonicclonic seizures in adults and children.

13.08.09

872

Prulifloxacin (600mg) Tablet

For acute uncomplicated lower urinary tract infection (simple cystitis), complicated lower UTI, acute exacerbation of chronic bronchitis.

30/10/2007

873

Temoporfin 1mg/ml Injection (Additional Strength)

Same as Approved.

08.07.08

874

Atazanavir 150mg + Ritonavir 50mg capsules

Anti HIV.

12/12/2006

875

Cilostazole E.R Tablet (100mg/200mg)

For management intermittent claudication.

30/10/2007

876

HPMC 0.3% +Dextran 0.1% + Glycerin 0.2%

For the temporary relief of burning and irritation due to dryness of the eye and for use as a protection against further irritation. For the temporary relief of discomfort due to minorirritations of the eyes or to exposure to wind or sun.

06.07.10

877

Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion

for the treatment of diarrhoea of mixed infection in adult patients.

17.08.09

878

Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100ml

Each 100ml contains; pazufloxacin mesylate eq.to pazufloxacin-300mg or 500mg

For the treatment of respiratory tract infections, urinary tract infections and abdominal infections in adults.

09.07.08

879

Propofol (1% w/v) with medium chain triglycerides (MCT)

Advice to FDA for amendment of existing permission to include MCT (BP) as excepient with the condition of 2yrs PMS data to be submitted.

02/09/2005

880

Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength)

As Approved

30/10/2007

881

Budesonide controlled release capsule

Eacg CR capsule contains; budesonide-3mg

For the treatment of ulcerative colitis.

30/08/2005

882

Clozapine Tablet200mg (Addl. Strength)

Indicated in the management of Schizophrenic patients.

19.08.09

883

Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg

For Mineral & Vitamins deficiency states in adult patients.

06.07.10

884

Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet

For IBS.

12/12/2006

885

Metoprolol ER + Amlodipine tablets (Additional Indication)

For coronary artery disease/ischaemic heart disease.

16.07.08

886

Ampicillin 250mg + Dicloxacillin 250mg tablet

Antibiotic.

13/12/2006

887

Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets

18.07.08

888

Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w

For short term treatment of chronic wounds including stage III & IV pressure sores, leg ulcers.

06.07.10

889

Nimesulide injection

Additional indication; for short treatment of adult patients with inflammation & pain associated with arthritis, soft tissue, ENT condition, trauma, dental pain, musculo skeletal & gynaecology & obstretric painful condition.

20/09/2005

890

Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w

Is indicated for the relief of stuffy,running nose associated with colds and influenza, also post nasal drip, sinusitis.

19.08.09

891

Sitagliptin Tablet (25mg/50mg/100mg)

Each film-coated tablet contains; sitagliptin-25mg, 50mg, 100mg

As adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes.

31.10.2007

892

Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg

For the treatment of patients with co-morbid depression and axiety.

08.07.10

893

Enoxaparin Sodium Injection (Addl.Indication)

Treatment of acute ST-segment elevation myocardial infarction including patients to be managed medically or with subsequent percuaneous coronary intervention (PCI).

19.08.09

894

Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel

For acute Musculoskeletal pain.

14/12/2006

895

Miglitol (50mg) + Metformin HCl SR (500mg) tablet

For adult with Type-II diabetes mellitus where simple drug therapy, diet and exercise do not result in adequate glycemic control.

31/10/2007

896

Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg + 850mg + 1000mg tablets

For the treatment of type-II diabetes mellitus when single drug therapy along with diet, exercise do not result in adequate glycemic control.

21.07.08

897

Agomelatine Tablets 25mg

Each film coated tablet contains; agomelatine-25mg

For the treatment of major depression in adult patients aged 18 â?? 65 years only with normal liver functions.

10.09.2012

898

Alendronate sodium (earlier approved 10mg)

5mg

Based on expert comments

06/03/2000

899

Alprazolam tablets

Each tablet contains; alprazolam-0.25mg,0.5mg,1mg

Anxiolytic agent- Indicated in the treatment of anxiety associated with depression.

1988-June

900

Amiloride + Frusemide tablets

Each tablet contains; amiloride-5mg, frusemide-20mg,40mg

1989-June

901

Ascerbine

For burns.

1970- December

902

Azithromycin Tablet 250mg/500mg

For the treatment in uncomplicated multidrug resistant enteric fever only.

06.03.13

903

Cefetamet Pivoxil Hcl oral suspension 250mg/ml

Anti-biotic.

15/02/2006

904

Chlorthalidone

100mg to 200mg

A long acting oral diuretic.

1961- March

905

Ciprofibrate tab

Each tablet contains; ciprofibrate-100mg

Indicated in treatment of primary hyperlipidaemia resistant to appropriate dietary management including cholesterolaemia, hypertriglyceriaemia and hyperlipidaemia (Fredrickson types Iia, Iib, III and IV)

01/05/1998

906

Daclatasvir Dihydrochloride 30mg/60mg Tablet &bulk

Each film coated tablet contains; daclatasvir dihydrochloride eq.to daclatasvir-30mg, 60mg

For use with Sofosbuvir for the treatment of patient with chronic hepatitis C virus (HCV) genotype 3 infection.

14.12.15

907

Desloratadine (2.5mg) + Ambroxol (30mg) + Guiphenasine (50mg) + Menthol 1mg/5ml Syrup

For productive cough.

02/03/2005

908

Diclofenac diethyl ammonium plaster

Each plaster of 10cm x 15cm dimension contains diclofenac diethyl ammonium-174mg

21/05/1997

909

Diclofenac sodium injection

Each 3ml ampoule contains; diclofenac sodium-75mg

1987-June

910

Dimethothiazine

20 mg tabs

Anti-histamic drug.

1969- October

911

dl-norgestrel + Ethinyloestradiol

Each tablet contains; dl-norgestrel-300mcg, Ethinyloestradiol-30mcg

1976-October

912

Ferrous sulphate

Each show release tablet contain Ferrous sulphate- 160mg

1972- November

913

Heparin Sodium Topical Solution 1000 IU/ml (Additional Dosage Form)

For the management of post infusion superficial thrombophlebitis.

16.01.14

914

Hydrcortisone 17-butyrate cream/oitment

Hydrocortisone 17-butyrate-0.1%

Topical corticosteroid- Indicated in the treatment of conditions responsive to topical corticosteroids e.g, eczema, dermatitis, psoriasis, lichen simplex.

1985-August

915

Indapamide SR tab

Each SR coated tab contains; indapamide-1.5mg

12/06/1996

916

Intra uterine infusion

Each 100gm syringe contains; oxytetracycline hcl-500mg, furazolidone-500mg, clioquinol-500mg

05/07/1993

917

Irsogladine Maleate TabletÂ 2mg /4mg

Each uncoated tablet contains; irsogladine maleate-2mg, 4mg

For gastric ulcers, improvement of gastric mucosal lesion (erosion, hemorrhage, redness and edema) caused by acute gastritis and acute exacerbation stage of chronic gastritis.

10.05.10

918

Lidoflazine

Each tablet contains; Lidoflazine-60mg (1 tablet daily for 1st week, 2 tablets for 2nd week, 3 tablets for 3rd week)

Coronary Vasodilator- Indicated in the treatment as Ischaemic heart disease and prophylaxis after treatment of myocardial infarction.

1974- August

919

Lignocaine IP + Aluminium Hydroxide IP + Magnesium Hydrochloride IP + Activated Dimethicone-20 NF

Each tablet contains & each 5ml suspension contains; Lignocaine IP-50mg, Aluminium Hydroxide IP-300mg, Magnesium Hydrochloride IP-100mg, Activated Dimethicone-20, NF-50mg

1978-September

920

Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution

For steroid responsive inflammatory ocular condition.

14.02.07

921

Metronidazole + Furazolidone + Kaolin + Pectin

Each 5mL containS; Metronidazole-40mg, Furazolidone-30mg, Kaolin-1gm, Pectin-20mg

1977-October

922

Midodrine Hydrochloride 2.5 mg Tablet

Each film coated tablet contains; midodrine hydrochloride eq.to midodrine 2.5mg

For the treatment of symptomatic orthostatic hypotension.

02.09.16

923

Montelukast tabs

Each uncoated tablet contains; montelukast sodium eq.to montelukast-4mg, 5mg, Each film coated tablet montelukast sod.eq.to montelukast-10mg

RMP

13/02/2002

924

Morphazinamide Hcl.

0.5 g tabs

Anti T.B Drug, pulmonary tuberculosis.

1967- July

925

Mosapride

Each film coated tablet contains; mosapride citrate dihydrate eq.to mosapride citrate-2.5mg, 5mg.

RMP- gastroesophagal reflux diseases (GERD) and gastrointestinal symptoms (heartburn/vomiting) associated with chronic gastritis.

13-03-2001

926

Methylcobalamine 500mcg + folic acid 1.5mg + alpha lipoic acid 100mg + B6-3mg + Thiamine 10mg capsule

For diabetic neuropathy

29.11.07

927

Naloxone Hcl. Injection

Each ml contains; Naloxone hcl-0.02mg,0.4mg,1.0mg.

Indicated for the complete partial reversal of narcotic depression including respiratory depression, induced by opioids including natural and synthetic narcotics, propoxyphene methadone, and certain narcotic-antagonist analgesics, nalbuphine, pentazocin aÞ¡

28/07/1992

928

Niflumic acid

Each capsule contains; Niflumic acid-250mg

1979-May

929

N-N-decamethylene-N-N-decamethylene-bis-amino quinaldine

0.25mg-Loz, 0.4%- oint.

Anti-bacterial.

1962- May

930

Omeprazole inj.

Each vial contains; omeprazole sod. Eq.to omeprazole-40mg

06/09/1994

931

Oxytetracycline long acting injectable

Each ml contains; oxytetracycline dihydrate in 2-pyrrolidone vehicle system-200mg

In the treatment of anaplasmosis and their annulata infection.

1990- May

932

Phenyl propanolamine + isopropamide + diphenyl pyralline hcl

Each phenylpropanolamine hcl-50mg, isopropamide-2.5mg, diphenyl pyralline hcl-5mg

1971- September

933

Piroxicam capsules

Each capsule contains; piroxicam-10mg

Anti inflammatory agent- Indicated in the treatment of rheumatoid arthritis, ankylosing spondylitis and other musculoskeletal disorders.

1986-August

934

Ramipril

Each cap. Contains; ramipril-1.25 mg,2.5mg,5mg,10mg.

ACE inhibitor- Indicated in the treatment of hypertension, cardiac failure. And also for myocardial infarction (29-11-94).

1991- August

935

Rizatriptan tab & bulk locally

Each uncoated tab contains; rizatriptan benzoate eq.to rizatriptan-5mg,10mg

For acute treatment of headache phase of migraine with or without aura in adults only.

27-02-2003

936

Tenoxicam dispersible tabs

Each dispersible tab contains; tenoxicam-20mg

31/05/1995

937

Terbutaline sulphate

Each mL contains; Terbutaline Sulphate-0.5mg

1980-July

938

Terizidone

Anti T.B. Drug- Indicated in the treatment of tuberculosis.

1981-June

939

Tetramisole Hydrochloride

Tetramisale Hydrochloride-30%

1973-July

940

Topotecan injection concentrate

Each single dose vial contains; Topotecan hcl eq.to topotecan 4mg/vial

Metastatic ovarian cancer after failure of first line chemotherapy.

15-06-1999

941

Trimethoxazine

Tranquiliser (minor)

1965- April

942

Trospium Chloride film coated tablet 20mg

Each film coated tablet contains; trospium chloride BP- 20mg

For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frequency.

01.06.09

943

Udenafil Tablet 100mg/200mg

Each film coated tablet contains; udenafil-100mg, 200mg

For the treatment of erectile dysfunction

15.09.11

944

Urea

Each mL contains; Urea (30%)-300mg

Hospital supply

1975-August

945

Vildagliptin Tablets 50mg/100mg

Each tablet contains; vildagliptin-50mg, 100mg

As an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes mellitus.

25.07.08

946

Zidovudine + Lamivudine

Zidovudine-600mg, lamivudine-300mg

For treatment of HIV.

2004

947

Î²-pyridyl carbinol

New formulation but a new drug

Vasodilator delayed action tablets.

1964- July

948

Acetyl salicylic acid Injection

2005-October

949

Fluvoxamine Maleate100/150mg ER Tablets

For the treatment of obsessive compulsive disorder (OCD)and depression.

19.08.09

950

Imipenem 50mg + Clistatin 50mg

Treatment of infection caused by susceptible bacteria for the following indication as in neonates and infants (below 3 months of age) 1. Lower respiratory tract infections 2. Urinary tract infections 3. Intraabdominal infections 4. Bacterial septicemia 5.Þ¡

14.07.10

951

Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream

For atopic dermatitis.

31/10/2007

952

Racecadotril dispersible tablet (10mg/30mg) (new dosage Form)

For diarrhea.

15/12/2006

953

Testosterone Undecanoate 250mg/ml Injection

Each ml contains; testosterone undecanoate-250mg

For Testosterone replacement therapy of male hypogonadism when testosterone dificiency has been confirmed by clinical features or biochemical tests.

22.07.08

954

Abatacept powder for injection 250mg/vial

Each vial contains; abatacept-250mg

For the treatment of adult patients with severe active rheumatoid arthritis, who had an inadequate response to one more DMARDs such as methotrexate or TNF antagonists.

22.07.08

955

Gabapentin ER 450/600/900mg tablet

Each film coated E.R tablet contains; gabapentin-450mg, 600mg, 900mg

For the treatment of neuropathic pain and as adjunctive therapy in the treatment of partial seizures with or without secondary generalisation in adults.

15/12/2006

956

Imedeen branded capsule of fish extract + ascorbic acid + zinc.

08/11/2005

957

Lidocaine Lozenges 100mg (Additional Strength)

Same as Approved

15.07.10

958

Lidocaine Lozenges 200/300mg (Addl. Indication)

For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract.

19.08.09

959

Methyl cobalamine 500mcg + folic acid 1.5mg + B5-5mg + Zn.sulphate 25mg + Cr.Polynicotinate 200mcg + selenium 65mcg + inositol 1.5mg + alpha lipoic acid 100mg capsule

For Vitamins and mineral deficiency states.

31/10/2007

960

Aceclofenac dispersible tablet 100mg (new dosage form)

As Approved.

21/12/2006

961

Actarit 100mg Tablets

Each film coated tablet contains; actarit-100mg

For the treatment of rheumatoid arthritis patients.

22.07.08

962

Combipro (probiotic product)

Each sachet containing; saccharomyces boulardii-5 billion, L. sporogenous-60 million, L. acidophilus-60 million, bifido bacterium-10 million, bacillus mesentricus-10 million

24/10/2005

963

Methylcobalamine 500mcg + folic acid 1.5mg + alpha lipoic acid 300mg + Benfothiamine 50mg Capsule

For diabetic neuropathy.

13.11.07

964

Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg

For the treatment of essential hypertension.

16.07.10

965

Risperidone long acting injection (Addl. Indication)

Indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of Bipolar-1 disorder.

29.08.09

966

Cefprozil tablet & powder for oral suspension

i) Each film coated tablet contains; cefprozil USP-250mg, 500mg, ii) Each 5ml of recons.syrup contains; cefprozil-125mg

For the treatment of patients with mild to moderate upper respiratory tract infection, lower respiratory tract infection, skin & skin structure infection.

29/08/2006

967

Etodolac 300/300mg +Thiocolchicoside 4/8mg

For the treatment of patients with acute painful musculoskeletal conditions.

19.07.10

968

Exemestane 25mg Tablet (Addl. Indication)

Indicated for adjuvant treatment of Post Menopausal Women with estrogen receptor positive early breast cancer who have received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy.

29.08.09

969

Methyl prednisolone aceponate-1mg + salicylic acid-50mg ointment

For treatment of psoriasis.

19.11.07

970

Spironolactone tablets

Each tablet contains; spironolactone-50mg

For the management of primary hyperaldosteronism and edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema, nephrotic syndrome, essential hypertension and hypokalemia.

17/11/2005

971

Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets

For the treatment of HIV infection in adults.

23.07.08

972

Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets

For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups.

01.09.09

973

Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form)

Same as Approved.

23.07.08

974

Celecoxib 100/200mg +Diacerein 50/50mg

For the treatment of adult patients with osteoarthritis of knee and/or hip joints.

19.07.10

975

Cranio plastic (resinous material)

Each kit consists of 2 sets of powder & sterile liquid component. The quantity of powder & liquid in each unit is 30g powder/17ml. (A)-powder component (%w/w) methyl methacrylate polymer-79.6%, methyl methacrylate styrene copolymer-19.9%, benzoyl peroxideÞ¡

For cranial defects repairing.

17/11/2005

976

Doxofylline tablets & Syrup

i) Each tablet contains; doxofylline-200mg, 400mg ii) Each ml contains; doxofylline-20mg

For the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD).

31/08/2005

977

Propanol 50gm + povidone iodine-1gm in 100ml solution

For surgical & hygenic hand disinfection.

19.11.07

978

Cefixime + Ornidazole tablets

Regretted to give permission for mfg/mrk

05/12/2005

979

Combikit of artesunate, sulphadoxine and pyrimethamine tablets

Each combikit contains one tablet of; artesunate-150mg,200mg, sulphadoxine IP-500mg,750mg, pyrimethamine IP-25mg,37.5mg

For the treatment of p.falsiparum resistant malaria patients (age 9-14 yrs and above).

25/07/2006

980

Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets

For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function.

01.09.09

981

Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop

For reduction of part operative inflammatory condition of eyes.

24.07.08

982

Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg

For the treatment of essential hypertension.

19.07.10

983

Propanol-18 gm + Ethenol(100%)-45gm in 100ml solution

For surgical & hygenic hand disinfection.

19.11.07

984

1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg (Each Co-pack contains :- 1 capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir DisoÞ¡

For the treatment of HIV infections in adults.

19.07.10

985

Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cmÂ², 12.5cmÂ², and 25cmÂ²contains: Buprenorphineâ?¦5mg/10mg/20 mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days).

For the treatment of severe opioid responsive painconditions which are not adequately responding to non-opioid analgesics.For Hospital supply only.

03.09.09

986

Doxorubicin hydrochloride liposomal injection

Each ml of i.v liposomal encapsulated injectable contains; doxorubicin Hcl-2mg (in 10ml, 20ml glass vial for single use only).

For the treatment of metastatic ovarian carcinoma in patients who are refractory to paclitaxel & platinum based chemotherapy and also in AIDS related kaposi's sarcoma.

23/08/2006

987

Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops

For the reduction of post operative inflammatory conditions of the eye.

24.07.08

988

Methylcobalamine 500mg + Alpha lipoic acid 100mg

Communicated that no such FDC yet appr.by this dtc.

13/12/2005

989

Voglibose disp.tab.0.2mg/0.3mg

As Approved

20.11.07

990

Calcipotriol scalp solution and cream

i) Each ml of scalp solution contains; calcipotriol-50mcg (30ml total pack), ii) Each gm of cream contains; calcipotriol-5mcg

For the treatment of psoriasis vulgaris.

12/05/2005

991

Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup (Additional strength)

Same as Approved.

25.07.08

992

Ceftriaxone 2gm + Tazobactum 250mg for injection

As Approved

21.11.07

993

FDC of atorvastatin + fenofibrate

Each film coated tablet contains; atorvastatin calcium eq.to atorvastatin-10mg, fenofibrate-160mg

For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function.

01/08/2006

994

Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg

Additional strength

19.07.10

995

Trospium Chloride ER Capsules 60 mg

For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency.

04.09.09

996

Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication)

For the treatment of secondary hyperparathyroidism in patients with stage 3 or stage 4 chronic kidney disease.

05.08.08

997

FDC of Drospirenone + Ethinylestradiol

Each tablet contains; drospirenone-3.0mg, ethinylestradiol-0.03mg

For use as oral contraceptive for women.

16/05/2005

998

Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml

Indicated for ocular surface anaesthesia during ophthalmologic procedures.

30.07.10

999

Methylprednisolone aceponate-1mg + Mupirocin-20mg cream

For the treatment of atopic dermatitis.

21.11.07

1000

Metoclopramide (as HCl) 200mg/400mg per ml Intranasal Solution

For the treatment of nausea and vomiting.

09.09.09

1001

Rivastigmine capsules 1.5/3.0/4.5/6.0mg

Each capsule contains; 1.5mg, 3.0mg, 4.5mg, 6.0mg

For the treatment of mild to moderately severe dementia associated with Parkinson's disease.

17/04/2006

1002

Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength)

Same as Approved.

05.08.08

1003

Citicholine(as Sod.)-200mg/500mg /750mg granules per sachet

As Approved

26.11.07

1004

Isosorbibe 20 mg + Hydralazine 37.5 mg tablets

For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status.

18.09.09

1005

Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional Indication)

A) FDC is indicated as triple combination therapy with a PPARy agonist (i.e a thiazolidinedione) as an adjunct to diet and exercise in patients inadequtely controlled on their maximal tolerated dose of metfomin and a PPARy agonist. B) FDC is also indicateÞ¡

02.08.10

1006

Metoprolol Tartrate (Conventional) tablet

25mg/50mg/100mg

For addl. Indications; i) myocardial infarction, ii) cardiac arrhythmia, iii) functional heart disorder with palpitation, iv) migraine prophylaxis

30/06/2006

1007

Omalizumab Injection

Each vial contains; Omalizumab 75mg, 150mg (with adequate solvent solutions in ampoules)

For the treatment of adult patients with moderate to severe persistent allergic asthma whose symptoms are inadequately controlled with inhaled corticosteroids.

26.10.2005

1008

Acrivastine Capsules 8mg

Each capsule contains; acrivastine-8mg

For the symptomatic relief of allergic rhinitis.

26.09.11

1009

Almotriptan Tablet 6.25mg/12.5mg

Each film coated tablet contains; almotriptan malate eq.to almotriptan-6.25mg, 12.5mg

For acute treatment of migraine attacks with a history of migraine with or without aura in adults. Important limitation: -use only after a clear diagnosis of migraine has been established. -not intended for prophylactic therapy of migraine. -not indicatedÞ¡

05.10.12

1010

Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional strength)

As approved

14.02.07

1011

Arformoterol (as Tartrate) 15mcg/2ml Inhalation Solution

Each 2ml contains; arformoterol tartrate eq.to arformoterol-15mcg

For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

29.05.09

1012

Atorvastatin 10mg + Aspirin 75/150mg Capsules

For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease.

18.01.08

1013

Beclotiamine hydrochloride & Beclotiamine napadisylate

Treatment of coccidiosis in poultry.

1970- December

1014

Benazepril hcl + Hydrochlorthiazide tabs

Each tab contains; benazepril hcl-5mg,10mg,20mg, Hydrochlorthiazide-6.25mg,12.5mg,25mg

For the treatment of mild to moderate hypertension.

21/05/1998

1015

Betahistine Dihydrochloride SR Tablets 24mg/32mg/48mg

For the symptomatic treatment of peripheral vertigo.

14.03.13

1016

Cefuroxime axetil

Each tablet contains; cefuroxime (as cefurexime axetil)-125 mg,250mg,500mg

Antibiotic- Indicated for lower & upper respiratory tract infection,UTI, gynaecological infection, skin or soft tissue infection etc.

1990- May

1017

Cefuroxime injection

Each vial contains; cefuroxime-250mg,750mg,1.5gm

Antibiotic- Indicated in the treatment of respiratory tract infections, UTI, ENT soft tissue infections etc.

1988-June

1018

Cephalexin + Bromhexine cap

Each capsule contains; cephalexin-250mg,500mg, Bromhexine (as hcl)-4mg,8mg, Each 5ml of reconstituted suspension contains; cephalexin monohydrate eq.to cephalexin-125mg,250mg, bromhexine hcl eq.to bromhexine-2mg,4mg (appr 27-1-95)

RTI characterized by excessive or viscid mucous.

16/09/1994

1019

Cyclosporin 0.05% eye drops

Each ml contains; cyclosporin-0.5mg

For treatment of moderate to severe dry eye syndrome (keratoconjunctivitis sicca)

10/03/2003

1020

Diazepam rectal solution

Each ml contains; diazepam IP-2mg,4mg.

Emergency treatment of convulsions as well as chronic prophylaxis against febrile seizures.

17-06-1999

1021

Diltiazam tablets

Each tablet contains; diltiazam hcl eq.to 30mg,60mg of diltiazam.

Coronary vasodilator- Indicated in the treatment of andina pectoris and chronic stable angina only.

1987-July

1022

Donepezil hcl.

Each film coated tablet contains; donepezil hcl-5mg, 10mg

Indicated in the treatment of mild to moderately severe Alzheimer's dementia

22-03-2001

1023

Enzalutamide 40 mg soft Capsule

Each soft capsule contains; enzalutamide-40mg

"For the treatment of adults with metastatic castration resistant prostate cancer whose disease has progessed on or after Docetaxel therapy.

18.12.15

1024

Imipramine Pamoate

Each capsule contains; i)-Imipramine Pamoate eq to 75 mg of Imipramine, ii)-Imipramine Pamoate eq to 150 mg of Imipramine

1979-May

1025

Intralipids intravenous fat emulsion

1981-October

1026

Iron-sorbitol citric acid complex

2ml (50mgFe+++)

Haematinic-Parentral iron (Colloidal iron complex).

1962- May

1027

Iron sorbitol citric acid complex (Injection of colloidal iron)

1969- January

1028

Iso-dihydo-ethaverine chloride

Antispasmodic

1965- April

1029

Isoptin hydrochloride

Each 2mL contains; Isoptin Hydrochloride-5mg

1974- September

1030

Lacosamide film coated tablet 50mg /100mg /150mg /200mg

Each film coated tablet contains; lacosamide-50mg, 100mg, 150mg, 200mg

As an adjunctive treatment of partial onset seizures in patients > 17 years of age.

10.06.10

1031

Levofloxacin Ophthalmic Solution (0.5%)

Each ml ophthalmic solution contains; levofloxacin hemihydrate eq.to levofloxacin-5mg

For the treatment of susceptible bacterial conjunctivitis.

04/03/2005

1032

Lignocaine cream (10 & 25gm tube)

Lignocaine (base)-2%, silver sulphadiazine-1%, chlorhexidine glyconate-02%

Temporary pain relief & to prevent infection in cuts & burn, wounds, nick, scrapes, scratches, abrasion, herpes zoster, bed sores.

18/06/1996

1033

Lithium carbonate

Each capsule contains; Lithium Carbonate-250mg

1972- November

1034

Maduramicin 1% premix

Each kg of 1% premix contains; maduramicin amonium-10gm, maduramicin amonium-0.5%

As an acid for the prevention of coccidiosis in broiler chickens.

07/07/1993

1035

Mepenzolate methylbromite

25 mg

Anticholinergic

1961- March

1036

Mesalazine (5-Amino salicylic acid) tablets

Each enteric/resin coated tablet contains; mesalazine-250mg,400mg, 5-amino salicylic acid rectal suspension enema contains; 5-ASA-4gm/60ml

Ulcerative colitis.

1989-June

1037

Mexiletine capsule/injection

Each capsule contains; mexiletine hcl-50mg,150mg, Each ampoule of 10ml contains; mexiletine hcl-250mg

Anti arrhythmic agent- Indicated in the treatment of existing or anticipated ventricular arrhythmias and ectopic beats such as those found after myocardial infarction and in ischaemic heart disease for arrhythmias induced drugs and for idiopathic arrhythmÞ¡

1985-August

1038

Miconazole Nitrate

Each gm of powder contains; Miconazole Nitrate-20mg

1975-August

1039

Mifepristone

Each uncoated tablet contains; mifepristone-200mg

By gynaecologist only- for medical termination of intrauterine pregnancy through 49 days of inception.

13-02-2002

1040

Nicorid capsules

Each capsule contains; menthyl valerate-100mg, quinine anhydrous-15mg, camphor-10mg, oil of eucalyptus-10mg

Used as an anti smoking agent.

06/06/1997

1041

Nimorazole

Each tablet contains; Nimorazole-250mg

For trichomoniasis.

1977-October

1042

Oxyfedrine

Tablets; Oxyfedrine-8mg, Solution; oxyfedrine-10mg, Injection; Each mL oxyfedrine-2mg

Coronary Vasodilator- for Angina pectories, Myocardial infarction and Coronary insufficiency.

1973-July

1043

Phenylbutazone sodium

1963- August

1044

Phospholipids Fraction from Bovine Lung (surfactant) 50 mg/vial

Each vial contains; phospholipid fraction from bovine lung (surfactant)-50mg/vial

Preventive use in premature neonates with a high risk of respiratory distress syndrome.

12.09.16

1045

Povidone Iodine USP

Povidone Iodine USP-4% (Scrub), Povidone Iodine USP-5%(Solution & oitment)

1978-September

1046

Pyrazinamide

Anti-tuberculosis.

1964- September

1047

Quinapyramine Sulphate

Quinapyramine Sulphate/Chloride (bulk drug)

1980-August

1048

Rifampicin

Each capsule contains; rifampicin-150 mg & 300 mg

1971- September

1049

Roxithromycin ER Tablets

Each extended release tablet contains; roxithromycin-300mg

Additional indication-skin & soft tissue infection.

08/03/2004

1050

Selegiline hcl

Each uncoated tablet contains; selegiline hcl-5mg.

Parkinsonism- Indicated in the treatment of Parkinson's disease.

1991- August

1051

Silymarin tablets

Each sugar coated tab contains; silymarin-70mg, also 140mg (Aug-1995, Ranbaxy,Microlab)

For supportive treatment in chronic liver disease and cirrhosis.

22/06/1995

1052

Simethicone

5 ml Gel & Tabs.

Gastric hyper acidity, heart burn, over indulgence.

1967- July

1053

Simethicone Orally disintegrating strip 62.5mg

For the treatment of flatulance and as adjuvant in hyperacidity.

14.11.10

1054

Sulbactum sodium + Cefoperazone sodium

Each vial of im/iv inj.contains; sulbactum sod. eq.to sulbactum-500mg, cefoperazone sod.eq.to cefoperazone-500mg

For treatment of i)-RTI, ii)-UTI(lower & upper), iii)-Septicemia, iv)-maningitis, v)-skin & soft tissue infections, vi)-endometritis, vii)-other infections of genital tract, viii)-intra abdominal infections, bone & joint infections.

16-03-2000

1055

Tiamulin soluble granules

Tiamulin hydrogen fumarate-45%

Indicated in the prevention & treatment of mycoplasma induced diseases of the respiratory tract including complications due to secondry infections only.

1986-August

1056

Triclobendazole + Levamisol hcl suspension

Each 100ml of suspension contains; triclabendazole 5gm,12.0gm, levamisole-3.75gm,7.5gm.

Indicated in the treatment and control of mature and developing immature infections of haemonchus, ostertagia, trichostrongylus, cooperia, nematodinus, bunostomum, oesophagastomum and dictyocaulus and all forms of liver fluke infection (early immature, imÞ¡

24/07/1992

1057

Valethamate Bromide

1976-November

1058

Voriconazole Powder for oral soluion (40mg/ml)

Anti-fungal.

21/02/2006

1059

Bimatoprost Eye Drps 0.1mg/ml

For the treatment of hypotrichosis of the eye-lashes by increasing their growth including length, thickness & darkness.

05.08.10

1060

Butarphenol tartrate 10mg/ml nasal spray

For management of pain in patients using opioid analgesics.

26.11.07

1061

Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets

For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections.

22.09.09

1062

Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength)

Same as Approved.

05.08.08

1063

Erlotinib Hcl tablets (25mg/100mg/150mg)

25mg/100mg/150mg

Additional indication; Erlotinib Hcl tab in combination with gemcitabine is indicated for the first line treatment of patients with locally advance unresectable or metastatic pancreatic cancer.

05/07/2006

1064

Chlorthalidone Tablet 6.25mg

For the treatment of mild to moderate hypetension.

03.10.09

1065

Deferasirox 100mg dis.tablet(addl. strength)

As Approved

28.11.07

1066

Leuprolide Acetate powder for Injection (7.5mg/vial 1 month depot injection)

For children in central precocious puberty.

10/08/2006

1067

Olopatadine Nasal Spray (0.6%)

Each 100 micro litre spray delivers; olopatadine Hcl-665mcg

For the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

06.08.08

1068

S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/w

For the painful & inflammatory conditions associated with joint, tendons, ligaments and muscles.

05.08.10

1069

Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg

For the treatment of lower RI, Skin and soft tissue, bone and joint infections and ENT infections in adult patients prone to antibiotic induced diarrhoea.

06.08.10

1070

Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary)

Each pippette contains: (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin

For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats.

03.10.09

1071

Loxoprofen Sodium tablet (60mg)

Each tablet contains; loxoprofen sodium-60mg

For the symptomatic treatment of pain and inflammation condition in patients with osteoarthritis.

14.08.08

1072

Methyl cobalamine 500mcg + folic acid 1.5mg + B6-3mg + Zn.sulphate 61.8mg + Ca.Pantothenate 10mg + Niacinamide-50mg + chrimium-50mcg capsule

For Vitamins and mineral deficiency patients.

29.11.07

1073

Metoprolol tartrate solution for i.v injection

1mg/ml

Additional indication: For the treatment of myocardial infarction.

25/08/2006

1074

Bemiparin Sodium Solution for injection(2500/3500IU) Addl.strength

2500IU & 3500IU

Additional strength.

29/08/2006

1075

Calcipotriol Gel 0.005% (additional dosage form)

For the treatment of moderate plaque psoriasis in adults.

03.10.09

1076

Dexibuprofen Suspension 50mg/5ml

Each 5ml contains; dexibuprofen-50mg

For the treatment of mild to moderate pain, reduction of fever.

19.08.08

1077

Mecobalamin 0.5mg + Pyridoxine 50mg + Benfotiamine 100mg capsule

For the treatment of diabetic Neuropathy.

29.11.07

1078

Voglibose0.3 + Metformin (SR) 500mg

Additional higher strength

06.08.10

1079

Amoxycillin Oral Suspension 200/400 mg per 5ml

in the treatment of infections due to susceptible strains of the designated micro-organisms in the condition of E.N.T infection, skin & skin structure infection, lower respiratory tract infection, genitourinary tract infection, gonorrhea, acute uncomplicaÞ¡

09.08.10

1080

Bromfenac Sodium Eye Drop (0.09%)

Each ml contains; bromfenac sodium 1.035mg eq.to 0.9mg bromfenac free acid.

For the treatment of postoperative inflammation & reduction of postoperative ocular pain in patients who have undergone cataract extraction.

19.08.08

1081

Lamotrigine MR Tablets 150mg (Addl. Strength)

Same as approved.

03.10.09

1082

Desflurane liquid for inhalation (240mg/bottle)

For induction & maintenance of anaesthesia.

22/02/2006

1083

Ribavirin Caps (200mg)

200mg

Additional indication: 24 week treatment regimen in the subgroup of hepatitis-C (genotype-1) low viral load, patients, who are HCV RNA negative of 4 weeks treatment.

01/11/2006

1084

Ceftriaxone + Sulbactam injection (Additional Indication)

for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis.

18.08.08

1085

Doxophylline-400mg + Salbutamol(as sulphate)-2mg/4mg Tablets

For treatment of Bronchial asthma in adults.

29.11.07

1086

Metoprolol Tartrate ER Tablet 75mg (additional strength)

Same as approved.

03.10.09

1087

Olmesartan 40mg + Amlodipine 5mg (Additional Strength)

Additional indication: 1. For the treatmenmt of hypertension alone or with other antihypertensive agents 2. To use as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

09.08.10

1088

Ramipril (12.5mg/5mg/10mg/2.5mg) capsules

12.5mg/5mg/10mg/2.5mg

Additional indication: i) Prevention of MI, CV death or stroke in high risk CV patients. Ii) Prevention of MI CV death or stroke in high risk diabetes patients.

02/11/2006

1089

Citicoline Chewable tablet (500mg)

For the treatment of disturbance of consciousness as resulting from head injuries , brain operation and acute stage of cerebral infraction in adult only.

18.08.08

1090

Dexketoprofen Trometamol Gel 12.5mg/gm

For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle.

13.10.09

1091

Doripenem 500 mg powder for injection (Additional Indication)

Complicated intra-abdominal infections and complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia.

10.08.10

1092

Estradiol vaginal tablets

Each film coated tablet; estradiol USP 25mcg

For treatment of atrophic vaginitis due to estrogen deficiencies.

03/11/2006

1093

Gatifloxacin (as sequihydrate)-3mg + Flurbiprofen sod.-0.3mg/ml eye drops

For reduction of post-operative inflammatory conditions of eye, when bacterial infection exists.

29.11.07

1094

Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml)

For the treatment of productive cough.

18.08.08

1095

Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg

For the treatment of mild to moderate severe Alzheimer's Dementia.

15.10.09

1096

Nadolol tablet USP 20/40/80 mg

In the treatment of angina-pectoris, cardiac arrythmias & essential hypertension.

20.08.10

1097

Sertanidazole-300mg + Ofloxacin-200mg tablet

For treatment of diarrhoea of mixed infection in adults patients.

29.11.07

1098

Dexketoprofen Trometamol Injection 50mg/2ml

Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as postoperative pain, renal colic and low back pain.

22.10.09

1099

Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg)

For the treatment of iron deficiency anaemia.

18.08.08

1100

Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml)

For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy.

20.08.10

1101

Zoledronic acid 5mg/100ml solution for infusion (addl. indication)

Post-menopausal osteoporosis.

06.12.07

1102

Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication)

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

22.10.09

1103

Cyclobenzaprine 7.5mg tablets (Additional Strength)

Same as Approved.

18.08.08

1104

Metformin 500/500mg + Repaglinide 1/2mg

Indicated as an adjunct to diet and excersice to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide & metformin or who have inadequte glycemic control on a meglotinide alone or metformin.

20.08.10

1105

Olmesartan medoximil-20mg + Ramipril-5mg. Tablet

For treatment of essential hypertention.

12.6.07

1106

Adapalene 0.1% w/w

Each 15gm tube contains; adapalene-0.1% w/w

By RMP- for topical treatment of acne vulgaris.

15-03-2001

1107

Allergens

1978-September

1108

Amoxycillin

Each vial contains; Amoxycillin sodium eq to 250mg, 500mg & 1gm of Amoxycillin

1979-June

1109

Asiaticoside

For Expert only

1976-November

1110

Bumetinide

Each tablet contains; Bumetidine-1mg, Each mL contains; Bumetidine-0.25mg

Diuretic indicated in the treatment of oedema associated with congestive heart failure, coronary oedema, hepatic ascites and renal disease including nephrotic syndrome.

1980-August

1111

Chlordiazepoxide + Clidinium bromide

Each tablet contains; Chlordiazepoxide-5mg, Clidinium bromide-2.5mg

1973-July

1112

Clopidogrel for additional indication

Additional indication- in acute coronary syndrome.

10/03/2004

1113

Closantel 15% oral solution

Each 100ml contains; closantel-15.00gm

Mature and immature fasciola species, haemonchus species, strongyloides species, and also for external parasites like oestrus ovis boophilus microplus hyalomma a. Anatolicum in cattle and sheep.

03/10/1994

1114

Decitabine lyophilised powder for injection 50mg/20ml vial (additional indication)

For the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

09.04.14

1115

Deltamethrine

Each litre contains; delta methrine-12.5gm

1990-June

1116

Desoximetasone

Each 1 gm contains; Desoximetasone-2.5mg

Topical corticosteroid- Indicated in the management of various acute and chronic dermatoses viz eczema, nummular eczema, infantile eczema, atopical dermatitis.

1975-September

1117

Dextranomer soluidine complex

Dextranomer soluidine complex beads

1986-August

1118

Diodohydroxyquinoline + Berberine Hcl + Homatropine methyl bromide

Diodohydroxyquinoline-300mg+Berberine Hcl-40mg+ Homatropine methyl bromide-0.5mg

1970- January

1119

Docetaxel injection concentrate

Each single dose vial contains; docetaxel trihydrate eq.to anhydrous docetaxel-80mg (2ml/vial) and 20mg (0.5ml/vial) with docetaxel solvent 6ml & 1.5ml.

Indicated in the treatment of patients with locally advanced or metastatic breast cancer and small cell lung cancer.

20/06/1996

1120

Dolutegravir Tablet 50mg & Bulk

Each film coated tablet contains; dolutegravir sodium eq.to 50mg of dolutegravir

Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults weighing more than 40kg.

07.11.16

1121

Fenfluramine hcl SR caps.

Each SR capsule contains; fenfluramine hcl-60mg

09/07/1993

1122

Flupirtine Maleate Capsules 100mg

Each capsule contains; flupirtine maleate-100mg

For treatmentÂ of acute and chronic pain,Â i.e, for painful increased muscle tone of the posture and motor muscles, primary headache, tumor pain, dysmenorrhea and pain after traumatologic / orthopaedic operations and injuries.

15.06.10

1123

Glibenclamide 5mg + MetFormin SR 850mg tablet (additional strength)

As approved

15.02.07

1124

Glybenclamide

Each tablet contains; glybenclamide-5 mg

1971- September

1125

Idoxuridine

0.5% ophthalmic sol.

Simplex keratitis epithelial infection.

1967- July

1126

L-carnitine (tabs of l-carnitine 330mg was appr.in May-92)

Each single dose 5ml ampoule contains; levo-carnitine-1gm.

31-03-2000

1127

Levocetirizine ODS 2.5mg /5mg (Additional dosage form)

For allergic rhinitis and chronic urticaria.

14.01.15

1128

Mesna (Sodium-2-mercapto-ethane sulphonate)

Urotoxic agent- for prevention of urotoxic side effects associated with the treatment of malignant tumours by oxazaphosphorines.

1981-December

1129

Metformin Oral Solution (100mg/ml)

Each 1ml oral solution contains; metformin Hcl-100mg

As an adjunct to diet & excercise to improve the glycemic control in patients with type-II diabetes mellitus.

04/03/2005

1130

Metoprolol + Hydrochlorthiazide tablets

Each tablet contains; metoprolol-50mg, hydrchlorthiazide-12.5mg

1989-June

1131

Mosapride SR tab

Each uncoated SR tab contains; mosapride citrate dihydrate eq.to mosapride citrate anhd.-15mg

For treatment of gastroesophageal reflux diseases (GERD)

10/03/2003

1132

Nandrolone decanoate

Anabolic effect, depot effect.

1962- May

1133

Naproxen CR tablets

Each CR tab contains; naproxen-750mg

26/06/1995

1134

N-butanol + Citric acid + Physiological Sodium chloride

Each 5mL contain N-butanol-0.52gm, Citric acid-0.0025gm, Physiological Sodium chloride to mL

1972- November

1135

Nimodipine tablets/injection

Each tablet contains; nimodipine-30mg, Each 50mlcontains (injection); i.v infusion nimodipine-10mg, Each soft gelatin caps contains; nimodipine-30mg(cadila-1-2-93)

In the treatment and prevention of ischaemic neurological deficit occuring due to arterial spasm, following sub arachnoid haemorrhage.

31/08/1992

1136

Palonosetron Melt in Mouth Tablets 0.5mg

For prevention of chemotherapy induced nausea and vomiting.

19.03.13

1137

Pentazocine Lactate

Each mL containS; Pentazocine Lactate-30mg

1977-October

1138

Pilocarpine gel

Each gm contains; pilocarpine hcl-40mg

For the management of intraocular pressure in glaucoma

24-06-1999

1139

Pipenzolate methylbromide

5 mg

Anticholinergic

1961- March

1140

Piroxicam injection i.m

Each ml contains piroxicam USP-20mg

Indicated in the treatment of musculoskeletal disorders, acute gout, pain after operative intervention following acute trauma and in primary dysmenorrhoea (12 years age or older)

1991- August

1141

Primoxan tablets

Each tablet contains; metoclopramide-5mg, dimethylpolysiloxane-250mg

1985-August

1142

Pyrazinamide dispersible tabs

Each dispersible tab contains; pyrazinamide-250mg

Short course treatment of tuberculosis in the paediatric age group.

06/06/1997

1143

Salbutamol Sulphate

Each 5mL contains; Salbutamol Sulphate-2mg

1974- October

1144

Sertraline tab

Each film coated tab contains; sertraline hcl eq.to 50mg,100mg sertraline and also 25mg (30-11-99 for panic disorder, unichem)

Major depressive disorders, obsessive compulsion disorders (OCD), panic disorders.

09/06/1998

1145

Simethicone (methyl polysiloxane)

1964- October

1146

Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets

For the treatment of acute migraine.

22.01.08

1147

Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets

Additional strength

04.11.09

1148

Tacalcitol ointment 4mcg

Each gram contains; tacalcitol monohydrate-4.17mcg eq.to tacalcitol-4mcg

For the treatment of psoriasis vulgaris in adults only.

26.09.11

1149

Tertatolol tablets

Each tablet contains; tertatolol hcl-5mg

Anti hypertensive agent- Indicated in the treatment of hypertension.

1988-June

1150

Tetracycline hcl + Broxyquinoline + Brobenzoxaldine

Tetracycline hcl-250+Broxyquinoline-200mg+Brobenzoxaldine-40mg

1969- January

1151

Thymogen intranasal formulation

Each vial contains; thymogen-5mg/0.7ml

As an add on to conventional chemotherapy in breast cancer patients.

12/02/2002

1152

Trazadone tablets/capsules

Each tablet/capsule contains; trazadone-25mg,50mg,100mg

1987-July

1153

Trifluoperazine & Tranylcypromine

1 & 10 mg

Antianxiety & depression.

1963-August

1154

Urosulfon

Russian pharmacopoeia drugs

1965- April

1155

Vemurafenib Tablet. 240mg

Each film coated tablet contains; vemurafenib-240mg

For the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test. Vemurafenib is not recommended for use in patients with wild-type BRAF melanoma.

19.10.12

1156

ZolmitriptanÂ Nasal spray

Zolmitriptan-5.0% w/v, benzalkonium chloride NF-0.01% w/v (as preservative). Each spray delivers; zolmitriptan-5mg

For the acute treatment of migraine with or without aura in adults.

29.05.09

1157

Hydroxyzine Hydrochloride SR Tablets 25/50/75mg

For management of pruritus due to allergic conditions such as chronic urticaria and atopic contact dermatoses, and in histamine -mediated pruritus.

20.08.10

1158

Levosulpiride Tablet (50mg/100mg) (addl. strength for addl. indication)

For depression and schizophrenia in adults.

12.6.07

1159

Levosulpride ER Tablet 100/150/200mg

For the treatment of depression and schizophrenia in adults.

27.10.09

1160

S-Metoprolol Succinate Oral Solution (Each Ml contains: S-Metoprolol Succinate 9.5mg equal to S-Metoprolol Tartrate 10mg)

For the treatment of haemodynamically stably patients with definite or suspected acute Myocardial Infarction to reduce cardio-vascular mortality.

19.08.08

1161

Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup

Additional strength

27.10.09

1162

Combipack of 12 Artesunate-50mg tablets & 6 Mefloquin-250mg tablets

For drug resistant P.falciparum malaria infection.

12.6.07

1163

Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional Indication)

In combination with bortezumab for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

23.08.08

1164

Rosuvastatin 5/10/20mg + Fenofibrate 67/145/160mg

For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function.

23.08.10

1165

Fexofenadine 120mg + Montelukast 10mg

For treatment of allergic rhinitis in adults only.

31.08.10

1166

Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg)

As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental infections, and halitosis.

25.08.08

1167

Pregabalin-75mg/150mg + Methylcobalamine 500mcg cap

For the treatment of adult patients with peripheral neuropathy.

12.10.07

1168

Propofol 10 mg + Lignocaine 2.5 mg per ml injection

Additional strength

27.10.09

1169

Doxycycline-100mg + L.bacillus spores-5 billion

For adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea.

12.11.07

1170

Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets

For the treatment of diabetic neuropathy.

27.10.09

1171

Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml)

Same as Approved.

25.08.08

1172

Cefprozil 250mg/500mg+Clav. Acid-62.5mg /125mg. Tab

For the treatment of adult patients with upper&lower RTI, Skin & Skin structure infection.

12.11.07

1173

Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg)

For the treatment of oedema associated with congestive heart failure, cirrhosis and nephritic syndrome.

25.08.08

1174

Olmesartan (20/40mg ) + Atorvastatin 5/10/20mg film coated tablets

For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients.

27.10.09

1175

Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml Pourâ??On Solution

Ready to use pour-on for cattle, sheep and goats. 1. For use in Cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g. house flies, to kill lice and protection against blackflies. 2. For use in sheep and goats for coÞ¡

29.10.09

1176

Dextrometharpahan HBr-10mg + Chlorphenaramine maleate-2mg /5ml syrup

For the temporary relief of cough due to throat irritation, sneezing & ruunning nose.

12.11.07

1177

Tretinoin Microsphere Gel (0.1% W/V)

For topical treatment of acne vulgaris.

26.08.08

1178

Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets

For the treatment of adult patients with osteoarthritis of knee and/or hip joints.

03.11.09

1179

Lornoxicam 8mg /2ml inj

For Short-term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery)

12.11.07

1180

Misoprostol 50Mcg tablet (Additional Strength)

Same as Approved.

26.08.08

1181

Apomorphine HCL-2mg/3mg Sublingual tablet

For erectile dysfunction in adult men.

12.11.07

1182

Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form)

Same as Approved.

27.08.08

1183

Escitlopram (as oxalate)10mg + Clonazepam-0.5mg tablet (addl. Strength)

For comobid depression and anxiety disorder.

12.12.07

1184

Guaiphenesin ER Tablet (600mg)

Each extended release tablet contains; guaiphenesin IP-600mg

For the treatment of productive cough accompanied by phlegm.

28.08.08

1185

Propofol 1% for injection (Additional Indication)

1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care.

05.11.09

1186

Clopidogrel 300mg Tablet (addl. Strength)

As approved.

02.09.08

1187

Doxophylline injection-10mg /ml

For bronchial asthama & COPD in adult patients, when oral therapy is in approriate.

31.12.07

1188

Rupatadine 10 mg + Montelukast 10 mg Tablets

For the management of seasonal allergic rhinitis (SAR).

10.11.09

1189

Acebutolol hcl + Hydrochlorthiazide tablets

Acebutolol hcl-200mg, hydrochlorthiazide-12.5mg

1986-August

1190

Aceclofenac 200mg (S.R) tablet

NSAID

22/02/2006

1191

Aceclofenac injection (150mg/3ml)

For short term treatment of pain due to post operative and post traumatic cases.

19.02.07

1192

Adenosine injections

Each 2ml ampoule contains; adenosine-6mg

Conversion to sinus rhythm of paroxysmal supraventricular tachycardia, including that associated with accessory by pass tracts (wolf-parkinson-white syndrome) when clinically advisable appropriate vagal maneuvers should be attempted prior to adenosine admÞ¡

08-07-1997 to 08-07-1999

1193

Alcaftadine eye drops 0.25% w/v & Bulk

Each ml contains; alcaftadine 2.5mg, benzalkonium chloride IP 0.005% w/v (as preservative), sterile aqueous vehicle q.s

For the prevention of itching associated with allergic conjunctivitis in patients between the age group 10 to 60 years.

21.11.16

1194

Alclometasone dipropionate cream/ointment

Alclometasone dipropionate-0.05%

Topical corticosteroid- Indicated for the relief of the inflammatory & pruritic manifestations of corticosteroid responsive dermatosis.

1987-July

1195

Ambroxol hcl + salbutamol + guaiphenesin + menthol

Each 5ml contains; Ambroxol hcl-15mg, salbutamol-1mg, guaiphenesin-50mg, menthol-1mg

Cough expectorant

16-06-1999

1196

Ammoidin & Ammidin

In treatment of leucoderm and depigment action.

1967- July

1197

Amoxycillin sodium + Sulbactum sodium inj. (i.m/i.v)

Each vial contains; sterile amoxycillin sodium eq.to amoxycillin-500gm,1gm & sterile sulbactum sodium eq.to sulbactum-250mg,500mg.

21/06/1996

1198

Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet

Each film coated tablet contains; arterolane maleate eq.to arterolone-150mg, piperaquine phophate-750mg

Treatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults.

19.10.11

1199

Atenolol tablets

Each tablet contains; atenolol-50mg,100mg

Anti arrhythmic agent- Indicated in the treatment of hypertension, angina pectoris, cardiac arrhythmias.

1985-September

1200

Biomycin (of tetracycline)

Russian pharmacopoeia drugs

1965- April

1201

Bupivacaine Hydrochloride

Each mL contains; Bupivacaine hydrochloride-10mg

1974- December

1202

Captopril + Hydrochlorthiazide tablets

Each tablet contains; captopril-25mg,50mg, hydrochlorthiazide-15mg,25mg

1989-July

1203

Ceftazidime pentahydrate injection

Each vial contains; ceftazidime-250mg,500mg,1gm,2gm

Antibiotic- Indicated for UTI, respiratory, skin soft tissue, G.I infections, meningitis etc.

1988-June

1204

Chlorthalidone

Diuretic

1963- September

1205

Choline Fenofibrate DR Capsule 45mg/135mg & DR Tablet 45mg/135mg.

Each hard gelatin capsule contains; choline fenofibrate eq.to fenofibric acid-45mg, 135mg

For treatment of mixed lipidemia in combination with statins, severe hypertriglyceridemia.

01.11.12

1206

Clidinium bromide

2.5mg to 10mg

Anti-cholinergic

1962- May

1207

Cyproterone acetate + ethinyl estradiol tab

Each 28 days pack contains; cyproterone acetate-2mg tab 28 no., ethinyl estradiol-0.035mg tab (7 nos)

Androgen dependent disease such as acne, alopecia & mild of hirsutism.

20-02-2003

1208

Decitabine Injection 30mg/vial (Additional pack size)

13.02.15

1209

Dexmedetomidine (as HCl) 100mcg/ml Injection

Each ml contains; dexmedetomidine Hcl eq.to dexmedetomidine-100mcg

For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting.

29.05.09

1210

Diacerin capsules

Each capsule contains; diacerin-50mg

By RMP

2004

1211

Diclofenac potassium

25mg, 50mg

For additional indication of migraine attack.

27-03-2001

1212

Diclofenac sodium inj.

Each ml contains; diclofenac sodium-25mg

14/07/1993

1213

dl-norgestrel + ethinyl oestradiol

Each tablet contains; dl-norgestrel-0.25mg, ethinyl oestradiol-0.05mg

Oral contraceptive

1971- October

1214

Fenfluramine Hcl

Each tablet contain; Fenfluramine Hcl -20mg

1972-December

1215

Fenpipramide Methobromide and p-Piperidinoethoxy o-carbomethoxy benzophenone Hydrochloride

Bulk drug

1980-October

1216

Feracrylum gel & solution (3%)

i)-Each gm contains; feracrylum 30mg soln, ii)-Each gm contains; 30ml of feracrylum in gel.

Additional indication & strength-for management of post-operative wounds, cuts, abrasions, as an haemostatic agent cum antiseptic.

13-02-2002

1217

Folic acid + Ferrous sulphate

Folic acid-0.5mg, Ferrous sulphate-150 mg

1969- January

1218

Furaltadone

Furaltadone-20%w/w

Poultry disease only

1973-August

1219

Ganciclovir sodium

Each capsule contains; ganciclovir-250mg, Each vial contains; ganciclovir-500mg.

For the prevention & treatment of cytomegalo virus disease in immuno compromised individuals and for the prevention of CMV disease in transplant receipients.

05/04/2000

1220

Ginko biloba

Each film coated tablet contains; dried extract of ginko biloba-40 mg(containing 9.6mg of ginko flavone gylycosides)

Herbal extract- In treatment of disorders in the functioning of the brain (reduced intellectual ability and alertness), giddiness buzzing in the ears, headache, poor memory, weakening of the voice resulting from anxiety.

08/09/1992

1221

Glycopyrronium bromide inhalation powder hard capsule with inhaler

Each capsule contains 63mcg Glycopyrronium bromide eq. to Glycopyrronium 50 mcg.

Indicated as a once daily maintenance bronchodilator treatment to relieve symptoms of patients with Chronic Obstructive Pulmonary Disease (COPD).

01.04.14

1222

Iobitridol Solution for Injection Each 100mg solution contain 65.81 g Iobitridol corressponding mass of Iodine 30gm

By intracavity route for Arthrography and Hysterosalpingography.

19.03.13

1223

Isoprenaline sulphate

Each ml contains; isoprenaline sulpahte-2mg

1970- January

1224

Loperamide

1978-October

1225

Losartan potassium tablets

Each film coated tab contains; losartan potassium-25mg,50mg,100mg

Mild to moderate hypertension.

16/06/1998

1226

Malathion

Malathion-0.5%

For treatment of pediculosis only.

1975-September

1227

Medicated dressing wash proof

Each perforated fresh coloured self adhesive plaster strip contains; medicated pad with cetylpyridinium chloride-0.3% w/w

06/10/1994

1228

Metoclopromide Monohydrochloride

Each tablet contains; Metoclopromide Monohydrochloride-10mg, Each 2mL contains; Metoclopromide Monohydrochloride-10mg

Anti-emetic.

1976-December

1229

Nilotinib Capsules 200mg

Each capsule contains; nilotinib-200mg

For the treatment of chronic and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib.

14.07.10

1230

Perindopril

Each tablet contains perindopril-2mg,4mg.

Anti hypertensive- Indicated in the treatment of hypertension.

1991- September

1231

Piperidolate hydrochloride

50 mg

Anticholinergic

1961- March

1232

Prazosin hydrochloride

Each tablet contains; prazosin hcl eq.to 1mg,2mg,5mg, (0.5mg for sun pharma-14-11-90)

All grades of essential primary hypertension and all grades of hypertension.

1990-June

1233

Prenylamine lactate

Coronary vasodilator.

1964- October

1234

Sodium valproate

Anti-epileptic drug- indicated in the treatment of all forms of epilepsis.

1981-October

1235

Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C.R. Tablet (Additional Strength)

Same as Approved

24.01.08

1236

Synthetic Diosmin

Each tablet/capsule contains; Synthetic Diosmin-150mg

Haemorhoids- indicated in the treatment of haemorrhoids.

1979-June

1237

Tetanum & Diptheria Immunoglobin (Human)

Anti-tetanus activity-500IU, Anti-diptheria activity-1000IU

Anti-tetanium activity -500IU, Anti-Diptheria activity 1000IU

1977-October

1238

Tinidazole + Norfloxacin tabs

Each tab contains; tinidazole-600mg, norfloxacin-400mg

09/05/1995

1239

Tirofiban (0.25mg/ml injection) (additional strength)

Tirofiban Hcl- (0.25mg/ml) in 25ml & 50ml pack sizes.

In combination with heparin for the treatment of acute coronary syndrome including patients undergoing PTCA or atherectomy.

09/03/2005

1240

Capecitabine 150/500mg Tablets (addl. Indication)

For the treatment of patients with metastatic colorectal cancer.

02.09.08

1241

Eperisone 50 mg + Paracetamol 500 mg Tablets

For improvement of mytonic conditions caused by neck shoulder arm syndrome, scapulhumeral periarthritis and low back pain in adult patients only.

10.11.09

1242

FDC of dipyridamole + acetylsalicylic acid

Each capsule contains; dipyridamole BP-200mg(MR), acetylsalicylic acid-25mg

To reduce the risk of stroke in patients who had transient ischaemia of the brain or completed ischaemic stroke due to thrombosis.

09.01.07

1243

FDC of S-amlodipine and valsartan

Each capsule contains; s-amlodipine besilate eq.to s-amlodipine-2.5mg, valsartan-80mg

For the treatment of mild to moderate hypertension in adult patients.

12.01.07

1244

Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength)

For the treatment of patients with HIV infection.

08.09.08

1245

Tadalafil tablet 20 mg (Additional Indication)

For the treatment of pulmonary arterial hypertension.

14.11.09

1246

Flurbiprofen Sodium 0.03% Ophthalmic solution USP

For the reduction of post-operative inflammatory condition.

14.11.09

1247

Ixabepilone lyophilized powder inj. 15mg/45mg per vial

Each vial contains; ixabepilone-15mg, 45mg

In combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is cÞ¡

15.09.08

1248

Zanamivir inhalation powder in capsule

Each capsule contains; zanamivir-5mg

For the treatment of both influenza A 7 B in adults and adolescent (â?¥ 12 years) who present with symptoms typical of influenza when influenza is circulating in the community.

24.01.07

1249

Dexmedetomidine HCl Injection (Additional Indication)

Sedation of non-intubated patients prior to and/or during surgical and other procedure.

14.11.09

1250

First Aid Dressing

Each first aid dressing strip (length 72mm x width 19mm) contains; absorbent wound pad with top layer containing polyethylene net with metalic silver coating.

As a first aid dressing for covering minor cuts, abrasion and lacerisation.

31.01.07

1251

Halometasone (as monohydrate ) 0.05% Cream

Each gram contains; halometasone monohydrate-0.5mg

For the relief of inflammatory and pruritic manifestation of non-infected corticosteroid responsive dermatoses like eczema.

11.09.08

1252

Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml)

For the treatment of metastatic colorectal cancer.

31.08.10

1253

Calcium and Magnesium 24% (Veterinary) injectable solution

Each ml of injectable solution contains; calcium gluconate-190mg, calcium glucoheptone-45mg, butaphosphan-4.0mg, magnesium chloride hexahydrate-60mg

For the treatment of milk fever, hypocalcaemia tetanies and disorders of calcium metabolism in dairy cattle.

16.09.08

1254

Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet

Additional strength

31.08.10

1255

Omega 3 fatty acid emulsion

Each ml contains; refined fish oil-100mg (containing EPA-12.5-28.2mg, DHA-14.4-30.9mg), egg lecithin-12mg, glycerol IP-25, Di-alpha tocopherol USP-0.223mg, water for inj.IP-q.s

For parentral nutrition supplement with long chain omega-3 fatty acid, when oral or enteral nutrition is impossible, insufficient or contraindicated.

04.01.07

1256

Paliperidone ER tablet 12 mg (Additional Strength)

Same as approved

14.11.09

1257

Euphorbia Prostrata Dry Extract :100mg tablet (addl. Indication)

For the treatment of 3Â° and 4Â° haemorrhoids (Addl. Indication)

14.11.09

1258

Memantine HCl ER Tablet 28mg

In the treatment of moderate to severe Alzheimer's disease

06.09.10

1259

Nabumetone USP 1000mg Tablet

Each film coated tablet contains; nabumetone USP-1000mg

For acute and chronic treatment of signs & symptoms of osteoarthritis & rheumatoid arthritis.

04.01.07

1260

Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength)

For the treatment of essential hypertension.

15.09.08

1261

Drotaverine + Aceclofenac (80mg + 100mg) Tablets

For the treatment of adult patients with muscular pain associated with spasm.

15.09.08

1262

Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules

For the treatment of acute diarrhoea in children.

04.11.09

1263

Pancreatin minimicrospheres 400mg capsule

Each capsule contains; enteric coated granules of pancreatin IP 400mg eq.to; 25000 F.I.P units amylase, 40000 F.I.P units lypase, 1600 F.I.P units ptrotease.

For the treatment of pancreatic exocrine insufficiency

04.01.07

1264

Buserelin Acetate injection 1mg/ml (Additional Indication)

indicated for the palliative (initial & maintenance treatment) of patients with hormone-dependent advanced carcinoma of the Prostate gland (Stage D).

08.09.10

1265

Lactulose oral powder 10gm

Each dose contains; lactulose BP-10gm

For the treatment of constipation, hepatic encephalopathy.

08.02.07

1266

Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets

For the treatment of mild to moderate hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy.

15.09.08

1267

Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution

For the local application in relieving pain in acute low backache, tendonitis, tenosinovitis and sprains.

17.11.09

1268

Aceclofenac 100mg Tablet

Each tablet contains; aceclofenac-100mg

For the treatment of pain & inflammation in patients with osteoporosis, rheumatoid arthritis and ankylosing spondylitis.

05.04.07

1269

Diacerein Modified Release Capsule 100mg

Symptomatic treatment of osteoarthritis of knee & hip.

20.11.09

1270

Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet

Additional higher strength

09.09.10

1271

Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength)

For the treatment of essential hypertension.

15.09.08

1272

Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets

For the treatment of essential hypertension.

24.11.09

1273

Disinfectant (D-125) solution

Each bottle contains; n-Alkyl dimethyl benzyl ammonium chloride-2.37% and n-Alkyl dimethyl ethyl benzyl ammonium chloride-2.37%, inert ingredients-95.26%

To disinfect hard , non-porous surfaces against micro-organisms like E.coli, Staphylococcus and Klebseilla.

03.05.07

1274

Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion

For the treatment of seborrhoeic dermatitis.

15.09.08

1275

Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable Tablet and Montelukast Sodium Oral Granules (Additional Indication)

For The relief of perennial allergic rhinitis in adults & pediatrics patients 6 months of age and older.

11.09.10

1276

2-Pyrrolidone acetamide

Each capsule contains; 2-Pyrrolidone acetamide-400mg, Each mL contains; 2-Pyrrolidone acetamide-200mg

To be used by physicians and in hospitals only

1978

1277

Albendazole tablets/suspension

Suspension-200mg/5ml, Tablet-200mg, 400mg

Anthelmintic

1986-February

1278

Amoxycillin

Capsule-Each capsule contains; 250& 500mg, Syrup-Each 5mL contains 125mg & 250mg of amoxycillin, Paediatric suspension-Each 1.25mL contains 125mg of amoxycillin

1979-January

1279

Aprotinin

i)Each 5mL ampoule contains; Aprotinin-100,000 KIU, ii)Each 10mL ampoule contains; Aprotinin-200,000 KIU

1974

1280

Atenolol (25mg, 50mg) + Hydrochlorthiazid (12.5mg)

Anti-Hypertensive

13-01-2005

1281

Bedaquiline Tablet 100 mg

Each uncoated tablet contains; bedaquiline fumarate eq.to-100mg bedaquiline

In adults (â?¥ 18 years), as part of combination therapy of pulmonary tuberculosis due to multi-drug resistant Mycobacterium tuberculosis when an effective treatment regimen cannot otherwise be provided.

14.01.15

1282

Bumetanide + Potassium chloride tablets

Each tablet contains; bumetanide-0.5mg, potassium chloride- 523mg

1983-February

1283

Caffeine + Ergotamine tartarate + Analgin + Trifluperazine Hcl

Each capsule contains; Caffeine-100mg, Ergotamine tartarate-1mg , Analgin-250mg, Trifluperazine Hcl-1mg

Poison E,H & Z drug

1976-March

1284

Candesartan cilexetil & hydrochlorothiazide tab

Each tab contains; candesartan cilexetil-16mg, hydrochlorthiazide-12.5mg

Essential hypertension (not for initial therapy)

03/01/2002

1285

Cefprozil tab & suspension & bulk (locally)

Each film coated tab contains; cefprozil USP-250mg,500mg, Each 5ml of reconstituted syrup contains; cefprozil USP-125mg

For treatment of patients with mild to moderate upper respiratory tract infection, lower respiratory tract infection, skin & skin structure infection.

10/01/2003

1286

Cinacalet (as HCl) Tablet 30/60/90mg

Each film coated tablet contains; cinacalcet hydrochloride-30mg, 60mg, 90mg

For the treatment of secondary hyperparathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma.

16.01.09

1287

Cisatracurium Besylate Bulk & 2mg/ml injection

Each single dose vial of 5ml contains; cisatracurium besylate eq.to 2mg/ml, Each multi dose vial of 10ml contains; cisatracurium besylate eq.to-2mg/ml

As an adjunct to general anaesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery.

14.03.16

1288

Clomipramine hcl tablet/capsule

Each tablet contains; clomipramine hcl-10mg,25mg,50mg, Capsule contains; clomipramine hcl-50mg.

Anti depressant- Obsessive compulsive disorders, phobic states and depression (when sedation is required).

1992- February

1289

Clopidogrel bisulphate

Each film coated tab contains; clopidogrel bisulphate eq.to clopidogrel-150mg

14/01/2004

1290

Cyclandelate

Each tablet contains; cyclandelate -200mg

1973-February

1291

Dabigatran Etexilate Mesilate eq to Dabigatran Etexilate 75mg/110mg/150mg

For the prevention of venous thromboembolic events in patients who have undergone orthopaedic surgery.

11.02.13

1292

Danazol bulk substances

1982-january

1293

Diclofenac gel

100gm of diclofenac diethlammonium gel contains-1.116g of diclofenac diethylammonium eq.to 1gm of diclofenac sodium.

1991- March

1294

Diclofenac sodium ophthalmic solution

Sterile solution contains; diclofenac sodium-0.1% (1mg/ml)

Indicated in post operative inflammation in patients who have undergone cataract operation.

27/01/1995

1295

Diclofenac sodium sustained release tablets

Each sustained release tablet contains; diclofenac sodium-100mg, 75mg(15-1-93 systopic)

1988-January

1296

Elemental Iron + Iron Polymaltose + Vitamin B5 + Vitamin B12

Each tablet contains; 40mg of Elemental iron in a complex of iron polymaltose, Vitamin B5-2mg, Vitamin B12-40 mcg, Drops-Each mL contains; 50mg of elemental iron in a complex of iron polymaltose, Syrup-50mg of elemental iron in a complex of Iron polymaltÞ¡

1977-February

1297

Ephedrine rosonate

50 mg

Samw as ephedrine, longer duration of action.

1961 January

1298

Ethionamide

0.25-1 g

Anti-Tuberculosis drug, in cases resistant to other drugs.

1962- February

1299

Ethynodiol diacetate 1 mg, Ethinyloestradiol 0.05 mg

Oral contraceptive

1970- February

1300

Ethynodiol diacetate + mestranol

Each tablet contains; ethynodiol diacetate-1mg, mestranol-0.05mg

Oral contraceptive

1971- January

1301

Fluconazole eye drops

Each ml contains; fluconazole-0.3% w/v

For fungal corneal, ulcers/keratitis only.

04/02/1998

1302

Frusemide + Spironolactone

Each capsule/tablet contains; frusemide-20mg, spironolactone-50mg,100mg

1984-September

1303

Hydrocortisone Aceponate 0.584mg/ml cutaneous spray solution

Each ml contains; Hydrocortisone Aceponate (HCA) 0.584mg/ml, Excipients-q.s

For symptomatic treatment of inflammatory and pruritic dermatosis in dogs.

06.01.17

1304

Etoricoxib roll on Topical Solution 1% v/v

For the treatment of pain, swelling & inflammatory conditions due to arthritis.

16.09.08

1305

Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg

Each uncoated tablet contains; iloperidone-1mg,2mg,4mg,6mg,8mg,10mg,12mg

For the acute treatment of adults with schizophrenia.

18.02.11

1306

Isapterl-II

Prepared from granulated Plantago ovata(Isapgol) seed husk (IP) and effervescent powder

1981-March

1307

Leprosy immunomodulator vaccine (based on Mw)

09/02/1999

1308

Levobetaxolol HCl Opthalmic Suspension 0.5%

Each ml contains; levobetaxolol hydrochloride 5.6mg eq.to levobetaxolol-5.0mg (free base)

For lowering of intraoccular pressure in patients with chronic open-angle glaucoma or occular hypertension.

19.01.10

1309

Linagliptin film coated Tablet 5mg

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important limitations of use: 1. Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 2. Has not been stÞ¡

23.01.12

1310

Lipoproteins extracted from human placenta

Lipoproteins extracted from human placenta-50%

1989-January

1311

Nebivolol (as HCl) 5mg + Valsartan 80mg Capsule

Each capsule contains; Nebivolol Hcl eq. to Nebivolol 5mg, Valsartan 80mg

For the treatment of essential hypertension in adults.

25/01/2006

1312

Nifedipine SR + Atenolo capsules

Each capsule contains; Atenolol BP-50mg, Nifedipine (SR)-20mg

1990- January

1313

Oestradiol phenyl propionate

Hormone

1964- January

1314

Ondansetron tablet and injection

i)-Each film coated tablet contains; ondansetron-4mg,8mg (as ondansetron hcl dihydrate), ii)-Each 2ml ampoule contains ondansetron-4mg as ondansetron hcl dihydrate, iii)-Each 4ml ampoule contains; ondansetron-8mg (as ondansetron hcl dihydrate)

In the treatment and management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.

12/02/1994

1315

Ornidazole tablet/infusion/bulk

i-Each tab contains; ornidazole-500mg, ii-ornidazole infusion-5mg/ml (100ml infusion bottle)

In the treatment of susceptible protozoal infections and anaerobic bacterial infections only.

13/01/1997

1316

Pentazocine (Lactate)

1 ml ampl.

Non-narcotic analgesic.

1969- January

1317

Phenylbutazone + Propyphenazone

Each tablet contains; Phenylbutazone-125mg, Propyphenazone-125mg

1980-February

1318

Pralidoxime chloride

Antidote for poisoning.

1966- March

1319

Propafenone tablets/injection

Tablets-propafenone-150mg,300mg, injection-each 20ml ampoule contains; propafenone-70mg

1987-January

1320

Proternol

1965- January

1321

Sildenafil citrate

Each film coated tablet contains; sildenafil citrate-25mg, 50mg, 100mg

By urologist, psychiatrist, endocrinologist-for treatment of erectile dysfunction in men.

08/01/2001

1322

Sumatriptan tablets

i)-Each film coated tab contains; sumatriptan (as succinate)-100mg,50mg,25mg, ii)-Sumatriptan injection contains; sumatriptan as succinate-6mg/0.5ml

Acute migraine attacks with or without aura, only where there is a clear diagnosis.

06/02/1996

1323

Testolactone

Each tablet contains; testolactone-50 mg

1972- March

1324

Testolactone

Testolactone-10mg/mL

1975-March

1325

Thiethylperazine

10 mg tabs., & 10mg/ml amp.

Antiemetic, antinausea and antivertigo action.

1968- January

1326

Ticlopidine hcl tablets

Each tablet contains; ticlopidine hcl-250mg

Antiplatelet agent- for the prevention of cerebro and cardio vascular accidents in patients suffering from asterial insufficiency in the legs and cerebral vessels and correction of platelet disorders induced by extra corporeal circuits during surgery withÞ¡

11/02/1993

1327

Timolol maleate ophthalmic solution

i)-Each 1 ml contains; timolol maleate eq.to 2.5mg of timolol, ii)-Timolol maleate eq.to 5mg of timolol.

Indicated in the treatment of chronic open angle glaucoma, ocular hypertension, ophthalmic glaucoma, intraocular pressure.

1985-July

1328

Timozolamide

Each capsule contains; timozolamide-5mg,20mg,100mg,250mg

For the treatment of adult patients with recurrent malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma.

17-01-2000

1329

Torsemide 10mg + Amiloride 5mg tablets

Each tablet contains; torsemide-10mg, amiloride-5mg

For the treatment of oedema associated with congestive heart failure & hypertension.

17.01.07

1330

Trifluoperazine dihydrochloride

Psychotic & psychoneurotics.

1967- February

1331

Tulobuterol Transdermal Patch 0.5 mg/ 1.0 mg / 2.0 mg.

Each transdermal patch contains; tulobuterol-0.5mg, 1.0mg, 2.0mg

For treatment of patients with Asthma and COPD without co-morbidity.

24.04.14

1332

Voglibose 0.2mg/0.3mg tablet (Mouth dissolving)

For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic drug or insulin preparation in addition to diet and or exercise do not result in adequate glycemic control.

28.12.07

1333

Zinc glucoheptonate

Mineral supplement.

1963- February

1334

Azelastine nasal spray

Each vial (10ml) contains; azelastine hcl-0.01gm/10ml

Allergic rhinitis and perennial rhinitis.

15-07-1997 to 15-07-1999

1335

Bromocriptine tablets

Each tablet contains; bromocriptine (as mesylate)-2.5mg,5mg,10mg

Gynaecological disorders- Indicated in the treatment of prolactin dependent menstrual cycle disorders, female infertility, pre-menstrual syndrome, hyper prelactinaemia in men.

1987-July

1336

Carteolol hcl tabs and ophthalmic solution

i)-Each film coated tab contains; carteolol hcl-5mg, ii)-sterile ophthalmic solution-2% w/v

In the management of hypertension and also in the prophylactic management of patients with angina pectoris. Ophthalmic silution is indicated in ocular hypertension, chronic open angle glaucoma and some secondry glaucomas.

09/07/1996

1337

Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 1000/500/250mg per vial of injection

For serious CRTI, uncomplicated and complicated UTI, Uncomplicated skin & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection.

24.01.08

1338

Clindamycin

Antibiotic- indicated in the treatment of gram +ve organism pathogens, stephylococcus & streptococci pneumococci.

1981-October

1339

Diazepam + Paracetamol

Each tablet contains; Diazepam-5mg, Paracetamol-500mg

1977-October

1340

Doxycycline Hcl

Each capsule contains; Doxycycline Hcl eq.to Doxycycline base - 100mg

1972-December

1341

Ethamsylate injection

Each two ml ampoule contains ethamsylate-250mg

Indicated in the Treatment of small vessel haemorrhage, menorrhagia, prophylaxis of periventricular haemorrhage in neonates.

1991- September

1342

Everolimus 2.5mg/5mg/10mg Tablets

1. For the treatment of tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery. 2. For the treatment of postmenopausal women with hormone receptor positive advanced breast cancer in combination with an aromatase inhÞ¡

21.03.13

1343

Flurbiprofen SR cap.

Each SR cap. Contains flurbiprofen-200mg

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

1990-June

1344

Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml)

i) Each 1ml vial contains; glatiramer acetate-20mg, ii) Each 1ml pre-filled syringe contains; glatiramer acetate-20mg

For the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.

03.06.09

1345

Glimepiride + pioglitazone tab

Each uncoated tab contains; pioglitazone hcl eq.to pioglitazone-30mg, glimepiride-1mg,2mg

Additional strength

13-03-2003

1346

Glybenclamide

Each tablet contains; glybenclamide-5 mg

1970-August

1347

Gramicidin

Russian pharmacopoeia drugs

1965- April

1348

Gynera tablets

Each tablet contains; gestoden-75mcg, ethinyloestradiol-30mcg

1988-July

1349

Hamycin hair cream

Each gm contains; hamycin 0.1% (eq.to hamycin 20,000 units)

1992- September

1350

Isopropamide iodide

5mg to 10mg

Anticholinergic

1961- March

1351

Ketoconazole tablets/suspension

Tablets-200mg each, suspension-20mg/ml

Oral anti fungal agent- Indicated in the treatment of systemic fungal infections, candidiasis, chronic mucocutaneous candidiasis, vaginal candidiasis, oral rush candiduria etc.

1986-October

1352

Levodopa & carbidopa CR tablet

Each CR tablet contains; carbidopa (anhydrous)-50mg, levodopa-200mg

19/10/1994

1353

Lomefloxacin eye drops

Each ml contains; lomefloxacin hcl-3mg

Bacterial infection of the eye.

22/07/1998

1354

Mebeverine hcl

Each tablet contains; mebeverine hcl-100 mg

Musculo tropic spasmolytic

1971- October

1355

Meloxicam ODT 7.5mg/15mg (Additional dosage form)

Non-steroidal anti-inflammatory.

23.02.15

1356

Melphalan

Anti-cancer drug.

1964- October

1357

Methandienone + Benzylalcohol

Each ml contains; Methandienone B.P-25mg, Benzylalcohol in sterile oily sol.-9% w/v

1970- January

1358

Methoxyflurane

Inhalation anaesthetic.

1963- October

1359

Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet (For additional indication)

Angina pectoris in adults.

20.02.07

1360

Metronidazole (skin ointment) gel

Metronidazole-1% w/w

19/07/1993

1361

Micafungin sodium for injection 100mg/vial (Additional Strength)

Treatement of patient with candidemia,acute Disseminated Candidiasis, Candida Peritonitis and abscesses.Treatment of patients with Esophageal Candidiasis,Prohylaxis of Candidia and Aspergillus Infections in patients undergoing Hemopoeitic stem cell transpÞ¡

02.05.14

1362

Miconazole eye drops/ophthalmic suspension/ointment

Miconazole-1%

For fungal infection of eye.

1989-July

1363

Naftopidil Tablets 25/50/75mg

Each uncoated tablet contains; naftopidil-25mg, 50mg, 75mg

For the treatment of dysuria associated with benign prostratic hyperplasia.

09.08.10

1364

Nevirapine oral suspension

Each 5ml suspension contains; nevirapine-10mg

Additional strength & indication-HIV infection in combination with other retroviral agents in neonates.

12/02/2002

1365

Nitrofurazone + Urea

Each bolus contains; Nitrofurazone-0.06gm, Urea-6.21gm

1973-August

1366

Levetiracetam Oral Solution (100mg/ml).

Anti-epileptic.

24/02/2006

1367

Norgestrel + hydroxy progesterone + norethisterone + acetoxy progesterone

dl-norgesterol, 17-alfa-hydroxy progesterone caproate, norethisterone acetate, 17-alfa-acetoxy progesterone.

1969- January

1368

Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsule

For GERD not responding to Omeprazole.

10/03/2005

1369

Perampanel 2mg/4mg/6mg/10mg/12mg Tablet

Each film coated tablet contains; perampanel 2mg/4mg/6mg/8mg/10mg/12mg

The adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.

02.12.16

1370

Phenyl-dimethyl isopropyl Pyrazolone + Diethyl-dioxotetrahydro pyridine + Paracetamol + Caffeine

Phenyl-dimethyl isopropyl Pyrazolone-150mg, Diethyl-dioxotetrahydro pyridine-50mg, Paracetamol-250mg, Caffeine(Anhydrous)-46.75mg

1980-November

1371

Pimozide

Each tablet contains; Pimozide-1mg, Pimozide- 4mg (forte tablet)

1974- December

1372

Policresulen + Cinchocaine ointment

Each gm of ointment contains; policresulen-50mg, cinchocaine-10mg

07/07/1995

1373

Propyl docetrizoate

Contrast medium in bronchography

1962- May

1374

Rofecoxib

Each tablet contains; rofecoxib-50mg

By RMP- same indication as approved earlier.

30-03-2001

1375

Sodium chloride + Hypertonic saline

Sodium chloride-20%, Hypertonic saline

For intra amniotic use

1975-September

1376

Sodium hyaluronate + chondroitin sulphate

Each ml of solution contains; sodium hyaluronate-30mg, sodium chondroitin sulphate-40mg

As a surgical aid in anterior & segment procedure including cataract extractran and inta ocular lens implantation.

04/04/2000

1377

Sodium Nitroprusside

Each vial contains; Sodium Nitroprusside USP-50mg

To be supplied for use in hospitals /medical institutions/ clinics only

1979-July

1378

Sodium valporate injection

Each vial contains; sodium valporate freeze dried powder-400mg/ml

In treatment of generalised epilepsy as well as for partial epilepsy in patients for whom oral therapy is temporarily not possible.

20-07-1999

1379

Tafluprost Eye Drops 0.0015% w/v

Each ml contains; tafluprost-0.015mcg

For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.

21.10.11

1380

Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet

Each film-coated tablet contains; emtricitabine-200mg, tenofovir disoproxil fumarate-300mg

For the treatment of HIV-1 infection in adults.

07/08/2006

1381

Tetracycline

Each capsule contains; Lymecycline eq. to 300mg of Tetracycline

1978-October

1382

Tetramisole Hcl

Each 5mL contain Tetramisole Hcl eq to 50mg of Tetramisole

1976-December

1383

Tobramycin injection

Each ml contains; tobramycin-10mg,40mg

Antibiotic- Indicated in the treatment of serious bacterial infections such as septicaemia, lower respiratory tract infections, serious central nervous system infections, intra-abdominal infections, complicated & recurrent urinary tract infections, skin &Þ¡

1985-September

1384

Trimethoxysilyl Quaternary Ammonium Chloride solution for spray inanimate surfaces for disinfection 0.71%.

Trimethoxysilyl quaternary ammonium chloride-0.71%

Surface protectant and disinfectant for persistent disinfection of all inanimate surfaces. Effective upto 14 days.

16.11.12

1385

Trolamine cutaneous emilsion

Topical emulsion containg; trolamine-0.67% w/w.

By dermatologists- for secondry erythema due to radiation therapies first, second degree burns and other non infected cutaneous wounds.

25/03/2004

1386

Verapamil Hcl.

5 ampl of 2.2 ml

Coronary vasodilation, coronary insufficiency heart, senile heart.

1967- July

1387

Acyclovir SR Tablet 1200 mg

For the treatment of uncomplicated Herbis Zoster in immunocompetent patients.

11.09.10

1388

Citicoline CR Tab 1000mg

For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia.

16.09.08

1389

Ranolazine ER 500mg Tablet

Each film coated ER tablet contains; ranolazine-500mg

For the treatment of chronic angina.

04.06.07

1390

S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets

For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

25.11.09

1391

Edaravone injection

Each ml contains; edaravone-1.5mg

For the improvement of neurological symptoms, disorder of activities of daily living, and functional disorder associated with acute ischaemic stroke.

27.07.07

1392

Lornoxicam 4mg + Eperisone 50mg tablet

For the improvement of myotonic conditions caused by neck shoulder arm syndrome, scapulumeral periarthiritis and low back pain in adult patients only.

13.09.10

1393

Montelukast Suspension 5mg/5ml

1) For the treatment of Prophylaxis & chronic treatment of Asthma in Pediatrics patients 12 months of age & older. 2) For relieving symptoms of seasonal allergic rhinitis in Pediatric patients 2 years of age & older & perennial allergic rhinitis in PediatÞ¡

16.09.08

1394

Tacrolimus Granules for oral suspension 0.2/1 mg per sachet

Prophylaxis of transplant rejection in kidney, liver or heart allograft recipient.

26.11.09

1395

Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate IP 0.5% w/w cream

Additional lower strenth

15.09.10

1396

Palonosetron Hcl injection

Each 5ml vial contains; palonosetron hydrochloride eq.to palonosetron-0.25mg

For the prevention of nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.

27.07.07

1397

Rifaximin Dispersible Tablet 200mg

For infections diarrhoea in adults.

26.11.09

1398

Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet

Additional strength

21.09.10

1399

Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg

Indicating for condition required Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction.

26.11.09

1400

Risedronate Sodium 150mg Tablet (Additional Strength)

As already approved.

16.09.08

1401

Sevelamer hydrochloride tablet

Each film coated tablet contains; sevelamer hydrochloride eq.to sevelamer-800mg

For the control of serum phosphorus in patients with chronic kidney disease on hemodialysis.

10.07.07

1402

Alprazolam SR 0.5mg tablet

Each SR tablet contains; alprazolam-0.5mg

Short-term treatment of anxiety disorder, anxiety associated with depression and panic disorders.

01.08.07

1403

Cinitapride Hydrogen Tartrate ER Tablet 3mg

For the treatment of gastroesophageal reflux disease (GERD) and functional inconveniences of the gastrointestinal motility.

26.11.09

1404

Levosulpiride Inj. 25mg/ml, 2ml

For the treatment of depression and schizophrenia in adults when oral therapy is not possible.

26.09.08

1405

Paracetamol 500mg/500mg + Thioclchicoside 4mg/8mg tablet

For the treatment of acute inflammation conditions associated with spasm in adults only.

21.09.10

1406

Ketorolac Tromethamine 0.4% w/v + Moxifloxacin 0.5% w/v Opthalmic solution

Additional lower strenth

21.09.10

1407

Metoprolol succinate ER 12.5mg/25mg/50mg tablet

Each ER film coated tablet contains; s(-) metoprolol succinate eq.to s(-) metoprolol tartrate-12.5mg, 25mg, 50mg

For the treatment of essential hypertension in adults.

01.08.07

1408

Paliperidone ER Tablet 3mg / 6mg / 9mg

Each film coated ER tablet contains; paliperidone-3mg, 6mg, 9mg

For the acute and maintenance treatment of schizophrenia.

29.09.08

1409

Sevelamer Carbonate (Additional Indication)

For control of serum phosphorus in patients with chronic kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl.

26.11.09

1410

Ceftiofur Crystalline free acid Suspension equi to Ceftiofur ---- 200 mg(veterinary)

Each ml suspension contains; ceftiofur crystalline free acid eq.to ceftiofur-200mg

For treatment of bovine respiratory disease (BRD, Shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle.

01.10.08

1411

Gliclazide modified release tablet

Each un-coated MR tablet contains; gliclazide-30mg, 60mg

For the treatment of type-II diabetes mellitus.

14.08.07

1412

Nilotinib Capsules 150 mg.

Treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase.

29.09.10

1413

Oxcarbazepine Tablets (Additional Indication)150/300/600 mg

Monotherapy in the treatment of partial seizures in children ages 4-16.

26.11.09

1414

Ceftiofur HCl Suspension (as HCl salt) ----500mg (veterinary)

Each 10ml syringe contains; ceftiofur eq.to (as the hydrochloride salt)-500mg

For treatment of sub clinical mastitis in dairy cattle at the time of dry off asssociated with staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.

01.10.08

1415

Etodolac 400mg + Paracetamol IP 500mg tablet

Additional higher strength

01.10.10

1416

Ketoprofen plaster 30 mg (7cm X 10 cm)

For the relief of musculoskeletal pain & inflammation.

11.12.09

1417

Orlistat 120mg capsule

Each capsule contains; orlistat-120mg

By specialist only- for obesity management including weight loss maintenance when used in conjunction with a reduced caloric diet in obese patients with an initial BMI > 30kg/m2 or â?¥27 kg/m2 in presence of other risk factors (viz.hypertension, diabetes, dÞ¡

22.08.07

1418

Amisulpiride SR Tablet 100 mg

Same as approved

27.11.09

1419

Ceftiofur HCl Suspension (as HCl salt) ----125mg (veterinary)

Each 10ml syringe contains; ceftiofur eq.to (as the hydrochloride salt)-125mg

For treatment of clinical mastitis in lactating dairy cattle asssociated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli.

01.10.08

1420

Deferasirox dispersible tablet 125mg/250mg/500mg

Each uncoated dispersible tablet contains; deferasirox-125mg, 250mg, 500mg

For the treatment of chronic iron overload due to blood transfusion (transfusional haemosiderosis) in patients aged 2years and above.

20.08.07

1421

Dried Aluminium Hydroxide Gel IP 600mg + Magnesium Hydroxide IP 300mg + Simethicone IP 25mg + Oxetacaine BP 10mg per 5ml syrup

For the treatment of symptoms of functional gastrointestinal disorders like irritable bowel syndrome, functional dyspepsia, peptic ulcer, gasteroesophagal reflux disease which include smooth muscle spasms, flatulence, abdominal distension, hyperacidity, gÞ¡

05.10.10

1422

Clostridium botulinum toxin type-A

Each vial contains; clostridium botulinum toxin type-A-100 units

For the treatment of benign essential blepharospasm in patients 18 years of age and above.

27.09.07

1423

Mycophenolate Sodium Enteric coated tablet 540 mg (Additional Strength)

Same as approved

29.10.09

1424

Mefanamic acid

Analgesic with Anti inflammatory properties- indicated in the treatment of acute & chronic pain post operative and postpartum pain, headaches, traumatic pain, muscular pain.

1976-January

1425

Nitrofurantoin SR Tab. 100mg

Each film coated sustained release tablet contains; nitrofurantoin BP-100mg

For the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.

01.10.08

1426

S(-) Metoprolol Succinate ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tablet

For the treatment of essential hypertension who need antiplatelet therapy especially for prophylaxis of atherombotic event.

07.10.10

1427

3-Methyl Pyrantel tartrate

100ml of the oral solution contains; 4gm of pyrantel tartrate (4%).

1970- May

1428

Acetyl salicylic acid + calcium carbonate + anhydrous citric acid

Each tablet contains; ASA-100mg,CC-30mg,ACA-10mg

1991- September

1429

Ademetionine enteric coated Tablets ..200mg/400mg

Each enteric coated tablet contains; ademetionine-1,4-butanedisulfonate eq.to ademetionine-200mg, 400mg

For the management of intrahepatic cholestasis and liver disease.

01.09.10

1430

Alphachymotrypsin

Each vial contains; Alphachymotrypsin-5mg

for use of eye specialists only

1973-August

1431

Amitryptylline Hcl

Each tablet contains; Amitryptylline Hcl-25mg

1978-October

1432

Apixaban tablets 2.5mg/5mg (Additional Strength & Additional Indication)

Prevention of stroke and systemic embolism in adult patients with non-valvular artrial fibrillation (NVAF), including those with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); ageâ?¥75 years; hypertension; diabetes mellitÞ¡

16.05.14

1433

Azatadine Maleate

Each tablet contains; Azatadine maleate-1mg

Anti-allergic- indicated for the symptomatic relief of allergic conditions such as hay fever, vasomotor rhinitis, urticaria, pruritus of allergic origin.

1980-November

1434

Cabazitaxel Injection 60mg / 1.5ml

Each 1.5ml contains; cabazitaxel-60mg, Diluent-5.7ml of 13% (w/w) ethanol in water for injection.

In combination with prednisone for treatment of patients with hormone-refractory metastatic prostrate cancer previously treated with a docetaxel-containing treatment regimen.

16.11.11

1435

Chlosal Butamide

Antifungal

1963- October

1436

Clofibrate

250 mg capsules

Coronary heart disease.

1967- July

1437

Clomipramine SR tablet

Each SR tablet contains; clomipramine hcl-75mg

19/10/1994

1438

Coumarin tabs

1995

1439

Dibazole

Russian pharmacopoeia drugs

1965- April

1440

Each sustained release tablet contains: Thiocolchicoside IP 8/16mg + Lornoxicam 8/16mg (Additional Strength)

For the treatment of patients with acute painful musculoskeletal conditions.

08.04.13

1441

Estradiol transdermal spray

Each spray delivers; 17-beta-estradiol-2mg

Signs & symptoms of estrogen deficiency due to menopause whether natural or surgically induced.

06/02/2002

1442

Ethacridine Lactate

Each mL contains Ethacridine lactate-1mg

1977-October

1443

Ethylestrenol

2 mg tabs

Anabolic agent (oral).

1962- June

1444

Fluorometholone 0.1% and fluorometholone forte liquifilm 0.25% ophthalmic suspension

Fluorometholone-ophthalmic suspension-0.1%, fluorometholone forte liquifilm suspension-0.25%

Of non infected/infected inflammatory ocular condition.

26/07/1996

1445

Fluorouracil

Cytotoxic

1964- December

1446

Flurbiprofen eye drops

Flurbiprofen-0.03%

1989-July

1447

Gemfibrozil capsules

Each capsule contains; gemfibrozil-300mg, (900mg-19-8-97)

Lipid lowering agent- Indicated for the treatment of adult patients with very high triglyceryl levels (type IV-hyperlipidemia).

1988-August

1448

Halcinonide + Neomycin Sulphate

Each gm contains; Halcinonide 1mg, Neomycin Sulphate eq to 2.5mg of Neomycin base

1979-July

1449

Ipratropium bromide + salbutamol sulphate

Each 2.5ml contains; ipratropium bromide-500mcg, salbutamol sulphate eq.to salbutamol-2.5mg

By RMP- for bronchospasm in patients suffering from chronic pulmonary disorders.

03/04/2001

1450

Isopropyl thioimidazolidine

Each tablet contains; Isopropyl thioimidazolidine- 5mg

1972-December

1451

Itraconazole capsules

Each capsule contains; itraconazole-100mg

Systemic aspergillosis and candidas cryptococcosis, sporotrichosis, paracoccidioidomycosis, blastomycosis and other rarely occuring systemic or tropical mycoses.

20/07/1993

1452

Ketotifen fumerate

Each ml contains; ketotifen fumerate eq.to ketotifen-0.25mg

For temporary prevention of itching of the eyes due to allergic conjuctivitis.

05/05/2000

1453

L-carnitine capsule/tab/oral solution

Each L-carnitine capsule contains; levo carnitine-330mg, tablets-250mg, oral solution-10ml of oral liquid contains l-carnitinr-1gm

Carnitine deficiency.

1990-June

1454

Lenvatinib hard gelatin capsule 4mg/10mg

Each capsule contains; i)lenvatinib mesylate 4.90mg eq.to lenvatinib 4mg, excipients q.s ii)lenvatinib mesylate 12.25mg eq.to lenvatinib 10mg, excipients q.s

For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer.

02.12.16

1455

Metrizamide

X-ray contrast medium- indicaed in lumber thoracic, cervical & total colummner myelography direct ventriculography etc.

1981-October

1456

Monensin sodium premix

Monensin sodium eq.to 100gm,200gm of monensin activity per kg.

Coccidiosis- In the treatment of coccidiosis in chicken and hens.

1985-September

1457

Nitazoxanide oral tablet, oral suspension

Each film coated tablet contains; nitazoxanide-500mg

17/03/2004

1458

Oxybutynin chloride

i)-Each uncoated tablet contains; oxybutynin chloride-2.5mg,5mg, ii)-Each 5ml syrup contains; oxybutynin chloride-2.5mg

For urinary incontinence, urgency and frequency in the unstable bladder, whether due to neurogenic bladder disorders or idiopathic detrusor instability and nocturnal enuresis.

03/09/1998

1459

Oxymetholone

5mg to 15mg

Anabolic agent

1961- March

1460

Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication)

Ovarian cancer, non-small cell lung cancer and AIDS related Kaposis Sarcoma.

22.01.08

1461

p-aminomethyl benzoic acid

Each 5ml ampoule contains; p-aminomethyl benzoic acid-50 mg

1971- October

1462

Pimozide Active Substance

1974- December

1463

Pseudoephedrine hcl + Ibuprofen tablet

Each tablet contains; ibuprofen-200mg,400mg, pseudoephedrine hcl-30mg,60mg.

For the relief of nasal congestion, headache, fever, bodyache and pains associated with sinusitis, flu and common cold.

28/09/1992

1464

Ramipril 10mg + HCTZ 12.5mg tablet (additional strength)

As approved.

20.02.07

1465

Ruxolitinib Tablet 5mg/15mg/20mg (Additional indication)

Treatment of patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.

23.02.15

1466

S(-) amlodipine + lisinopril tab

Each tab contains; S(-) amlodipine-2.5mg, lisinopril-5mg

For treatment of mild to moderate hypertension.

12/03/2003

1467

Seratrodast tablets 40mg/80mg

Each tablet contains; seratrodast-40mg, 80mg

As add-on therapy in bronchial asthma.

30.11.12

1468

Stanozolol inj.

Stanozolol-50mg/ml

1987-September

1469

Stavudine caps

Each cap contains; stavudine-15mg,20mg,30mg,40mg

Of adult patients with advanced HIV infection who are intoleratent of approved therapies.

21-07-1997 to 12-07-1999

1470

Stavudine powder for suspension

For HIV-1 infusion.

11/03/2005

1471

Sucralfate tablets

Each tablet contains; sucralfate-1gm

Anti ulcer- Indicated in the treatment of gastric duodenal & benign ulcer.

1986-November

1472

Triamterene + Hydrochlorthiazide

Each tablet contains; Triamterene-50mg, Hydrochlorthiazide-25mg

1975-September

1473

Trimipramine

Trimipramine maleate-10mg, 25mg

1969- January

1474

Yttrium-90 Microspheres InjectionÂ (Yttrium-90...3GBq (at the time of calibration) per vial)

Each vial contains; yttrium 90-3GBq (at the time of calibration)

For the treatment of unresectable metastatic liver tumors from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

05.06.09

1475

Zuclopenthixol (acetate/decanoate) injection

Each ml of inj.contains; zuclopenthixol acetate-50mg & 200mg, Each film coated tab contains zuclopenthixol-25mg(appr. 31/3/2000)

By psychiatrist only- treatment of acute psychosis including mania & excerbation of chronic psychosis acute & chronic schizophrenia.

29-07-1999

1476

Exenatide Injection (Additional indication)

Exenatide is a glucagon like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.

09.10.10

1477

Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension

For the treatement of post operative steriod responsive inflammatory ocular infections or risk of bacterial ocular infections exists.

01.12.09

1478

Moxifloxacin ophthalmic solution

Each ml contains; moxifloxacin hydrochloride eq.to moxifloxacin-5mg

For the treatment of bacterial conjuctivitis caused by susceptible organism.

19.10.07

1479

Tolperisone HCl Tablet 50 / 100 / 150mg

Each film coated tablet contains; tolperisone Hcl-50mg, 100mg, 150mg

For the relief of painful muscle spasms of the skeletal musculature.

01.10.08

1480

Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength)

Same as approved.

09.10.10

1481

Butorphanol tartrate nasal spray

Each ml of solution contains; butorphanol tartrate B.P-10mg, Each actuation delivers; butorphanol tartrate USP-1mg

For the management of pain when the use opioid analgesic is appropriate.

26.11.07

1482

Etoricoxib + Paracetamol (60mg + 500mg) Tablets

For the short term use in acute painful and inflammatory condition.

30.09.08

1483

Ropinirole ER tablet 2/4/8mg

for the treatment of signs & symptoms of idiopathic Parkinson's disease.

03.12.09

1484

Citicoline Oral Drops

For the treatment of disturbance of consciousness resulting from head injuries, brain operation & acute stage of cerebral infraction in adult.

30.09.08

1485

Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional Strength)

Same as approved

04.12.09

1486

Drosperinone + Ethinylestradiol tablets Same as approved

For the treatment of moderate acne vulgaris in adult females, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for Þ¡

09.10.10

1487

Erysimiine

Russian pharmacopoeia drugs

1965- April

1488

Levofloxacin oral Solution

Each 240ml bottle contains; levofloxacin hemihydrate eq.to levofloxacin-25mg/ml

For the treatment of adult patients (â?¥18 years of age) with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, complicated and uncomplicated UTI, skin and soft tissue infections, chronic bacterial prostatiÞ¡

22.11.07

1489

Etodolac USP 400mg + Tolperisone HCL 150mg tablet

For the treatment of acute inflammation conditions associated with spasm in adults only.

11.10.10

1490

Lornoxicam ER Tablet 8 mg (Additional Strength)

Same as approved

11.12.09

1491

Lornoxicam injection

Each 2ml vial contains; lornoxicam-8mg

For short term treatment of mild to moderate pain when oral administration is inappropriate (e.g. Afetr dental surgery).

10.12.07

1492

Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) Injection

Indicated for the treatment of mastitis, metritis, pneumonia, pleuritis, fever and relieving of acute pain in musculoskeletal disorders in animals.

30.09.08

1493

Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets

For the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing Children)

30.09.08

1494

Citicoline 500mg + Piracetam 400mg per 5 ml syrup

Additional dosage form

11.10.10

1495

Divalproex sodium sprinkle capsule

Each sprinkle capsule contains; divalproex sodium eq.to valproic acid-125mg, 250mg

As monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizure.

06.12.07

1496

Flurbiprofen plaster 20 mg (7cm X 10cm)

for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder.

11.12.09

1497

Apomorphine HCL-2mg Sublingual tablet

Each sublingual tablet contains; apomorphine hydrochloride-2mg

For the treatment of erectile dysfunction in adult men.

11.12.07

1498

Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup

For the treatment of chloroquine resistant/multidrug resitant on complicated malaria.

30.09.08

1499

Carvedilol Phosphate ER tablet 10/20/40/80mg

1. Mild to severe chronic heart failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension.

11.12.09

1500

Thiocolchicoside 0.25% + Methyl salicylate IP 100mg + Menthol IP 50mg + Absolute alchol IP 50mg per gm gel

For the topical treatment of painful muscles spasms of skeletal musculature.

11.10.10

1501

Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet

For the treatment of essential hypertension.

12.10.10

1502

Cabergoline 1mg Tablets (Additional indication)

For the treatment of hyperprolactinemia and inhibition of lactation.

01.10.08

1503

Doxophylline syrup

Each ml contains; doxophylline-20mg

For the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD).

13.12.07

1504

Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w cream

For the treatment of acute and chronic infected eczematous dermatitis.

15.12.09

1505

Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets

For the treatment of type II diabetes mellitus associated with dyslipidemia.

17.12.09

1506

L-Lysine hydrochloride cream

Each gm contains; L-Lysine HCl USP-150mg

For the treatment of wounds of various etiology.

03.12.07

1507

Pemetrexed disodium 500mg/100mg powder for sol. (Addl.indication )

In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

08.10.08

1508

Pregabalin 150mg/75mg + Methylcobalamin 750mcg + Alpha lipoic acid 100mg + Pyridoxine 3mg + Folic acid 1.5mg capsule

For the treatment of painful diabetic neuropathy in adults only.

12.10.10

1509

Betahistine Di hydrochloride CR capsule 24/32/48mg

Indicated in the treatment of Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss.

17.12.09

1510

Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule.

For Vitamin and mineral deficiency

13.10.10

1511

Glucosamine sulphate SR Tablet

Each SR tablet contains; glucosamine sulphate-750mg

For the treatment of osteoarthritis.

05.04.07

1512

Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary)

Each sachet contains; tylvalosin (as tartrate)-62.5% w/w.

For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment of diseases due to clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and tÞ¡

13.10.08

1513

Bortezomib inj.3.5mg/vial (Additional Indication)

Treatment of patients with multiple myeloma.

09.10.08

1514

Combipack of 21 tablets of FDC of Ethinylestradiol IP 0.03 mg + Levonorgestrel IP 0.15 mg and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron)

As contraceptive pill for women

13.10.10

1515

Gefitinib tab 250mg (Additional Indication)

Indicated for the first line treatment of patients with locally advanced or metastatic non small cell lung cancer (NSLC) who have activating mutationof the EGFRTK".

18.12.09

1516

Octreotide for injection

Each vial contains; octreotide acetate eq.to octreotide base 10mg, 20mg, 30mg

Acromegaly, gastro-entero pancreatic endocrine tumours, carcinoid syndrome, VIPomas, glucagonomas, Zollinger-Ellison syndrome, insulinomas for pre-operative control of hypoglycaemia.

18.05.2007

1517

Glatiramer Acetate injection (20mg/ml)

Multiple sclerosis.

21.02.07

1518

5-Fluorouracil

Each capsule contains; 5-Fluorourail-250mg

1977-November

1519

Acyclovir tablets/cream/ointment/ophthalmic ointment/suspension

Tablets-200mg, cream/ointment-5%, ophthalmic ointment-3%, suspension-400mg/5ml (30-7-91)

Anti viral agent- Indicated in the treatment of Herpes simplex virus infections of the skin including initial & recurrence genital herpes, herpes labiales, herpes simplex keratites.

1987-October

1520

Aloe Ext.

Russian pharmacopoeia drugs

1965- April

1521

Amitraz emulsifiable concentrate

Each ml emulsifiable concentrate contains; amitraz BP-50mg,125mg

06/08/1996

1522

Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet

Essential hypertension.

21.02.07

1523

Astemizole suspension

Astemizole-5mg/5ml

1988-August

1524

Atomoxetine 60mg capsule (Addl. Strength)

For ADHD

27/02/2006

1525

Azilsartan 40mg/80mg Tablet

Each uncoated tablet contains; azilsartan kamedoxil eq. To azilsartan medoxomil 40mg/80mg

Indicated for the treatment hypertension in adults patients, either alone or in combination with other antihypertensive agents.

16.12.16

1526

Candur-R (purified chick emryo cell rabies vaccine)

13/08/1993

1527

Carbenicillin Disodium

Each vial contains; Carbenicillin Disodium-1gm

Antibiotic

1973-August

1528

Catalin

Anti-cataract Preparation- indicated in the treatment of cataract.

1976-January

1529

Cefazoline sodium injection

Each vial contains; cefazolin sodium-0.5gm,1gm,250mg

Cephalosporin antibiotic- Indicated in the treatment of serious infections due to susceptible organisms-respiratory tract infections, urinary tract infections, skin billiary tract infections, septicaemia.

1985-September

1530

Cephapirin benzathine intramammary infusion

Each 10ml disposable syringe contains; 300mg of cephapirin benzathine activity in a stable peanut-oil gel

For the treatment of mastitis in dairy cattle during the dry period.

25.09.12

1531

Clobetasone 17-butyrate cream/ointment

Clobetasone 17-butyrate-0.05%

Topical corticosteroid- Indicated in the treatment of mild eczema, seborrhoic dermatitis and other steroid responsive disorders.

1986-December

1532

Combination of Lactic Acid Bacteria (VSL#3) Sachet

For mild to moderately active ulcerative colitis as an adjunctive therapy subject to condition that it should not be used in patients who are on steroids or immunocompromised.

08.04.13

1533

Desoximetasone 0.05% oitment

Desoximetasone-0.05%

1979-July

1534

Dihydroxyacetone + alcohol

Dihydroxyacetone-15% w/v, alcohol (95%)-40% v/v. Purified water-q.s

On prescription of a skin specialist only.

1971- October

1535

Doxepin cream

Doxepin hcl IP-5% w/w (eq.to doxepin-4.4%)

26-07-1997 to 26-07-1999

1536

Econazole Nitrate

Cream-Econazole Nitrate-1%, Vaginal tablet-Each tablet contains; Econazole Nitrate-150mg

Topical antifungal & antibacetrial agent, All fungal skin infections due to dermatophytes once vaginal candidiases

1980-December

1537

Enalapril maleate + Hydrochlorthiazide tablet

Each tablet contains; enalapril maleate-10mg,20mg, hydrochlorthiazide-25mg,12.5mg.

Hypertension in patients for whom combination therapy is appropiate.

08/10/1992

1538

Erdosteine (150mg/300mg) Capsules

Each capsule contains; erdosteine-150mg, 300mg

For chronic obstructive bronchitis.

11/03/2005

1539

Fexofenadine hcl tablets

Each tablet contains; fexofenadine hcl-120mg,180mg

In the treatment of relief of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria in adults only.

16/09/1998

1540

Fluprednylidene Acetate + Gentamicin Sulphate + 5-Chloro-8-hydroxyquinoline

Fluprednylidene Acetate-0.1%, Gentamicin Sulphate-0.1%, 5-Chloro-8-hydroxyquinoline-0.5%

1978-October

1541

Gadopentetic acid dimeglumine salt injection 469mg/1ml (0.5mmol) (Additional indication)

1ml solution for injection or infusion contains Gadopentetic acid, dimeglumine salt 469mg (0.5 mmol)

For use in MRI in adult patients to facilitate visualization of lesions with abnormal vascularity in the body (excluding heart).

23.02.15

1542

Guanethidine (as sulphate)

25mg to 50mg

Antihytensive

1961- April

1543

Hand wash liquid soap/hand lotion

Hand wash liquid soap/hand lotion contains; nonoxynol-9-2%w/v, chlorometaxylenol-0.5%w/v.

26/07/1995

1544

Ibuprofen

Ibuprofen-5% w/w, 10% w/w-cream, 10%-gel

In painful conditions.

1990- July

1545

Ifosfamide & Mesna (combipack)

Ifosfamide-1gm/vial, mesna-100mg/ml

NOC granted to the firm as it was earlier licenced by SLA (Maharashtra)

30-07-1999

1546

Ketoprofen controlled release capsules

Each cotrolled release capsule contains; ketoprofen BP-100mg

1989-July

1547

Lenograstim 263 mcg/vial (HAS free)

263mcg/vial

This product without (HAS free) was approved vide file of even no. dated 7-05-1997

29-03-2001

1548

Lincomycin hcl.

Lincomycin hcl eq.to lincomycin base-2% w/w

For acne vulgaris

11/05/2000

1549

Lithium carbonate

Each capsule contains; lithium carbonate-300mg

1970- June

1550

Luliconazole Cream 1%

Each gram contains; luliconazole-10mg

For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris.

03.06.09

1551

Mebendazole Active Substance

1974- December

1552

Methenolone

1mg and 5 mg tab., Injection

Anabolic agent

1962- June

1553

Methyldopa + Hydrochlorothiazide

Methyl dopa-250 mg, Hydrochlorthiazide-15 mg

1969- Februaryy

1554

Metronidazole tab

Removal of warning of carcinogenicity in rodents.

07/02/2002

1555

Mometasone furoate nasal spray 50 mcg/actuation (Additional Indication)

For the treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older.

21.05.14

1556

Norethisterone acetate + Ethinyl oestradiol

21 active-Each tablet contains; Norethisterone acetate-1mg, Ethinyl oestradiol-30mcg, 7 haematinic tablets-Each contains; Ferrous Fumarate-60mg

1975-September

1557

Paracetamol + D-propoxyphene Hcl

Each tablet contains; Paracetamol-300mg, D-propoxyphene Hcl-25 mg

1972-December

1558

Pilocarpine hcl tab

Each film coated tab contains; pilocarpine hcl BP-5mg

For treatment of radiation induced xerostomia in patients undergoing radiotherapy of head & neck cancer and in patients with sjogren's syndrome.

13-03-2003

1559

Pirfenidone film coated tablet ...200mg

Each film coated tablet contains; pirfenidone-200mg

For the treatment of idiopathic pulmonary fibrosis.

14.09.10

1560

Propranalol Hcl.

10 & 40 mg tablets & 5mg/5ml, 1mg/ml amp.

Cardiac drug indicated in angina pectoris, cardiac arrhythmia, pheochromacytoma and hypertrophic obstructive cardiac myopathy.

1967- August

1561

Sorafenib tablets 200mg (Additional Indication)

For hepatocellular Carcenoma.

22.01.08

1562

Sulbactum sodium + ampicillin

Each vial contains; sulbactum sod-0.5gm, (6-5-92)-250mg,1gm, ampicillin sod-1.0g, (6-5-92)-500mg,2gm

1991- September

1563

Sulphadimethoxypyrimidine

1963- October

1564

Tamsulosin + Finasteride

Each hard gelatin capsule contains; finasteride, tamsulosin-0.04mg (as modified release pellets)

For the treatment of sign & symptoms of benign prostate hyperplasia.

19/03/2004

1565

Trace metal additive infusion (TMA infusion)

Each ml contains; ZnSO4-0.660mg (heptahydrate eq.to elemental zinc 0.15mg), CuSO4-0.236mg (pentahydrate eq.to elemental copper 0.06mg), chronic chloride-1.83mg (anhydrous eq.to elemental chromium 0.6mg), MnSO4-0.047mg (monohydrate eq.to elemental magnaeseÞ¡

08/10/1994

1566

Triclofos

Hypnotic

1964- December

1567

Trifluridine Eye Drops 1% w/v

For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2.

08.12.11

1568

Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream.

For the treatment of patients suffering from neuralgia.

13.10.10

1569

Midazolam Hcl Syrup 2mg/ml

For selection,anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedure or before induction of anesthesia.

18.12.09

1570

Sertaconazole Nitrate Vaginal Tab.500mg

Each vaginal tablet contains; sertaconazole nitrate-500mg

For the treatment of vulvovaginal candidiasis in women.

13.10.08

1571

Fosfomycin Tromethamine Sachet 3gms

Each sachet contains; fosfomycin tromethamine eq.to fosfomycin-3gm

For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcus faecalis.

13.10.08

1572

Guaiphenasin Syrup 133mg/5ml

For the treatment of productive cough accompanied by phlegm.

18.12.09

1573

Paracetamol IP 500mg + Phenylephrine HCL IP 5mg + Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet.

For the treatment of fever associated with cold, nasal congestion in adults.

13.10.10

1574

Ixabepilone lyophilized powder (additional Indication)

As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to cytotoxic chemotherapy. Previous therapy should have included as anthracycline, a taxane, and capecitabine.

09.10.08

1575

Levocetirizine dihydrochloride 2.5mg + Montelukast 5mg dispersible tablet

Additional strength

13.10.10

1576

Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray

For symptomatic treatment of nasal congestion with running nose (rhinorrhea).

23.12.09

1577

Calcium citrate maleate Eq. to elemental calcium 250mg + Vitamin D3 IP 200 IU tablet

For the treatment of calcium and Vitamin D deficiency states

13.10.10

1578

Doxofylline 400 mg + Ambroxol 30 mg Tablets

For the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate.

23.12.09

1579

Eprosartan Mesylate 400 mg / 600mg Tablets

For the treatment of essential hypertension.

11.10.08

1580

Levonorgesterel 100mcg + Ethniyl estradiol IP 20mcg tablet

(Additional indication) For the treatment of moderate acne vulgaris in women more than 18 years of age who have no therapy contraindications to oral contraceptive therapy, desire contraceptiopn, and have achieved menarche.

13.10.10

1581

Ribavirin Capsules 200mg (Addl. Strength)

Indicated in combination with peg interferon alpha-2b for the treatment of naÃ¯ve adult patients with chronic hepatitis C with clinically stable HIV co-infection.

24.12.09

1582

Tretinoine Gel as Micro Sphere 0.04% % 0.1%

For topical treatment of Acne vulgaris.

14.10.08

1583

Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream

For the treatment of mild to moderate inflammed cutaneous mycoses.

13.10.10

1584

Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder Inhalation

For the treatment of patients with bronchial asthma and COPD, where the use of combination is found appropriate.

30.12.09

1585

Hydroxychloroquine Sulphate (Additional indication)

For the treatment of systemic lupus erythematosus.

17.10.08

1586

Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication)

Indicated in the regular treatment of patients with moderate to severe COPD with frequent symptoms and a history of exacerbations.

17.10.08

1587

Chlorohexidine Gluconate Gel 0.2%

For the prevention of Plaque and treatment of gengivitis.

30.12.09

1588

Tolperisone HCL 150mg + Paracetamol IP 500mg tablet

For the treatment of patients with acute painful musculoskeletal conditions.

21.10.10

1589

Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops

For post operative steroid responsive inflammatory ocular condition when bacterial ocular infections or a risk of bacterial ocular infections exists.

21.10.08

1590

Chlorohexidine Gluconate Mouth wash 0.1%

For the prevention of Plaque and treatment of gengivitis.

30.12.09

1591

Hyoscine Butylbromide 20 mg tablet (Additional Strength)

Same as Approved.

04.11.10

1592

Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules

For the treatment of acute inflammation conditions associated with spasm in adults only.

21.10.08

1593

Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup

For the treatment of non-productive cough.

06.07.09

1594

Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Form)

Same as Approved.

04.11.10

1595

Adapalene 0.1% + Benzoyl Peroxide 2.5% gel

Each gram contains; hydrous benzoyl peroxide eq.to anhydrous benzoyl peroxide-25mg + adapalene-1.0mg

For the treatment of acne vulgaris.

31.10.08

1596

Oxybutynin Gel 100 mg

For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency.

04.11.10

1597

B-Hydroxytheophylline

1969- Februaryy

1598

Bosentan (as monohydrate) Tablets 62.5mg/125mg

Each film coated tablet contains; bosentan monohydrate eq.to bosentan-62.5mg, 125mg

For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve excercise ability and decrease the rate of clinical worsening.

23.06.09

1599

Carvedilol tablets & bulk

Each tab contains; carvedilol-12.5mg,25mg

Essential hypertension only.

16/10/1998

1600

Cephalexin + Carbocisteine caps.

Each capsule contains; cephalexin monohydrate eq.to cephalexin-500mg,250mg, carbocisteine-150mg, Oral suspension each 5ml contains; cephalexin anhydrous-250mg, carbocisteine-150mg

30/10/1994

1601

Cephradine

Antibiotic- indicated in the treatment of infection of G.I., genito-utrinary, respiratory tract and soft tissue.

1976-January

1602

Clindamycin phosphate topical gel

Each gm contains; clindamycin phophate eq.to 1% of clindamycin.

Indicated in treatment of acne vulgaris.

1992- October

1603

Clobetasol propionate + Ammonium lactate gel

Clobetasol propionate-0.05% w/w, ammonium lactate-12% w/w

Dry hyper keratotoic steroid responsive dermatoses inflammatory manifestation of psoriasis (or eluding wide spread plague psoriasis).

07/08/1996

1604

Cloxacillin benzathine intramammary infusion

Each disposible plastic syringe contains; cloxacillin benzathine eq.to 500mg of cloxacillin

1987-October

1605

Colistin

50000 U/kg/day-inj,

Anabolic.

1962- June

1606

Dabigatran Etexilate (as Mesilate) hard gelatin Capsules 75mg/110mg/150mg

Each hard gelatin capsule contains; dabigatran etexilate mesilate eq.to dabigatran etexilate-75mg, 110mg, 150mg

For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation.

12.12.11

1607

Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg.

For OA & RA.

28/02/2006

1608

Diclofenac sodium tablets

Each tablet contains; diclofenac sodium USP-25mg,50mg

Anti inflammatory agent- Indicated in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, painful post operative, pain following dental surgery etc.

1985-September

1609

Diltiazam modified release tablets

Each MR tablet contains; diltiazam hcl-30mg, 60mg

1989-july

1610

Diltiazam sustained release tablets

Each SR tablet contains; diltiazam hcl-90mg,120mg

1989-july

1611

Dopamine Hydrochloride

Each 5mL contains; Dopamine-200mg

Sympathomemetic agent- Indicated for the correction of haemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma endotoxic septicenia, open heart surgery, renal failure.

1980-January

1612

Droperidol

Each ml contains; 2.5 mg droperidol

By RMP- to produce tranquilization and to reduce the incidence of nausea & vomiting in surgical & diagnostic procedures for premedication indication and as an adjunct in maintenance of general anaesthesia.

29-03-2001

1613

Epicillin

Capsules-250mg & 500mg of Epicillin, Injection-250mg & 500mg of Epicillin, Oral suspension-Each 5mL contains; 125mg & 250mg

1979-August

1614

Ergometrine + Oxytocin injection i.m

Each 1ml ampoule contains; ergometrine maleate-500 mcg, oxytocin-5 units

28/07/1995

1615

Glucomannan sachets (herbal medicine)

Each sachet containing glucomannan-0.75gm,1.0gm,1.3gm

For reduction of blood glucose level reduction serum lipid level.

06/09/1993

1616

Indomethacin suppositories

Each suppository contains; Indomethacin-50mg, 100mg

1970- July

1617

Iopromide

Each ml contains; iopromide-0.499 g, 0.623 g, 0.769 g

Used as a contrast medium for angiography.

1990- July

1618

Levocloperastine (as Fendizoate) Suspension eq. to Levocloperastine HclÂ 20mg / 5ml.

Each 5ml of suspension contains; levocloperastine fendizoate 35.4mg eq.to levocloperastine Hcl-20mg

For the treatment of non productive cough in adult patients

29.09.10

1619

Levofloxacin tabs and infusion

Each film coated tab 250mg,500mg. Infusion 5mg/ml (in 50ml & 100ml)

In treatment of acute mailliary sinusitis, acute bacterial excerbation, chronic bronchitis, community acquired pneumoniae, skin & soft tissue infection, complicated urinary tract infection or acute pyelonephritis.

23-07-1999

1620

Lincomycin Hydrochloride

Each capsule contains; Lincomycin hydrochloride-500mg

1972-December

1621

Mebendazole

Each tablet contains; Mebendazole-100mg

Broad spectrum anthelmentic- For the treatment of enterobiasis as carriasis, trichuriasis ancyclostomiasis, strongylodiasis (pin warm, large round warm, whip warm, hooks warm and thread warm.

1974- December

1622

Mecobalamine

Each ml ampoule contains; mecobalamine-500mcg

Treatment of peripheral neuropathies & megaloblastic anemia caused by vit.B12 deficiency.

14-02-2002

1623

Micronised Purified Flavonoid 1000mg (MPFF)

. "Each film coated tablet contains diosmin 900mg and flavonoids expressed as Hesperidine 100 mg of Micronised Purified Flavonoid fraction of Rutaceae 1000mg (MPFF)"

Acute hemorrhoid piles

28.11.14

1624

Mupirocin topical ointment

Mupirocin-2% w/w

For bacterial skin infection.

1991- September

1625

Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w Ointment

For the prevention and treatment of surgical wound infections in adult patients undergoing surgery.

03.01.12

1626

Orphenedrine citrate USNF + Paracetamol BP

Each tablet contains; Orphenedrine citrate USNF-35mg, Paracetamol BP-450mg, Each 2mL ampoule conatins; Orphenedrine citrate-60mg

1977-November

1627

Oxymetazoline Hcl

Oxymetazoline Hcl-0.25%

Paediatric

1978-October

1628

Pazopanib Tablet 200mg/400mg (additional indication)

For the treatment of patients with advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy.

23.02.15

1629

Pentazocine

Each tablet contains; Pentazocine base-50mg (as Hcl)

1973-August

1630

Pentoxifylline

Each dragee contains; Pentoxifylline-100mg, Each 5mL ampoule contains; pentoxifylline-100mg

Vasodialator- indicated in the treatment of arterial and arteriovenous circulatory disorders.

1975-November

1631

Prednicarbate cream

Each gram of cream contains; prednicarbate-2.5mg

Skin diseases where treatment with topical corticosteroid is appropriate.

06-08-1997 to 06-08-1999

1632

Psoralen + copper sulphate

Each tablet contains; Psoralen-10mg, copper sulphate-2mg

1971- October

1633

Residronate sodium (35mg) once weekly

35mg

19/03/2004

1634

Salicylazosulphapyridine

0.5 mg tablets

Ulcerative colotis, regional enteritis, non-secific colitis.

1967- August

1635

Sulpha-dimethoxy pyrimidine

Chemotherapeutic, long acting.

1961- April

1636

Tazarotene (1mg) + Mometasone Furoate (1mg) per gram cream

For plaque psoriasis.

01/04/2005

1637

Tiaprofenic acid tablets

Each tablet contains; tiaprofenic acid-200mg,300mg

Anti inflammatory agent- Indicated in the treatment of post-operative period, sprains, fractures, various conditions.

1986-December

1638

Tolperisone HCl 450mg + Diclofenac Sodium IP100mg SR tablets (Additional Strength)

For the treament of Patients with acute muscle/musculo skeletal spasm in adul.

12.04.13

1639

Trapidil

Each capsule contains; trapidil-100mg,200mg, Each ml of inj.contains; trapidil-50mg

For prevention of restenosis after percutaneous transluminai coronary angioplasty (PTCA) in patients of athero sclerosis arterial disease.

11/05/2000

1640

Triclabendazole bolus and suspension

Bolus-250mg,900mg, suspension-5%,10%w/v.

Broad spectrum flubicide- Indicated in the treatment of chronic fasciola gigantica, F.hepatica in sheep, goats, cattle and buffaloes.

1988-September

1641

Valsartan + hydrochlorthiazide tab

Each tab contains; valsartan-80mg,160mg+hydrochlorthiazide-12.5mg, Valsartan 160mg+hydrochlorthiazide-25mg

For treatment of mild to moderate hypertension.

18-03-2003

1642

Zanamavir inhalation powder 5mg/blister (Additional Indication)

For prophylaxes and treatment of both influenza A & B in adults and children (greater than or equal to 5 years)

22.01.08

1643

Aceclofenac Roll - On 1%

For the treatment of acute musculoskeletal pain in patients.

24.10.08

1644

Ondansetron Rapid Film Oral Strip 4/8 mg

For chemotherapeutic induced nausea and vomiting.

16.11.10

1645

Acebrophylline SR Tablet 200 mg

For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.

23.11.10

1646

Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet

For hypertension.

24/04/2006

1647

Citicoline Troches 200/500mg

For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerative damages and chronic cerebral vascular injuries in senile dementia.

31.10.08

1648

Amisulpride S.R.Bilayered tablet 200/400mg

For acute and chronic schizophrenic disorders, in which positive symptoms and or negative symptoms are prominent, including patients characterised by predominant negative symptoms.

03.11.08

1649

Ammonium Lactate Cream 12% w/w

Indicated For the treatment of Dry,scaly skin(xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these condition.

03.12.10

1650

Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules

For the treatment of hypocalcaemia and/or osteoporosis.

04.11.08

1651

Rabeprazole Sodium Powder oral suspension (sachet of 20 mg) (Additional dasage form)

Same as approved

03.12.10

1652

Acetyl Cysteine Eye Drops 5% w/v

Indicated the relief of Dry eye symptoms associated with defecient tear secretion, impaired or abnormal mucus Production.

14.12.10

1653

Atazanavir + Ritonavir(300mg + 100mg) FC Tablets

For the treatment of patients with HIV infection.

04.11.08

1654

Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml

Indicated for the Prophylaxis against alpha-hemolytic(viridans group) sreptococci before dental, oral and upper respiratory tract surgery.

14.12.10

1655

Timolol Maleate SR Eye Drops 5.0mg/ml

For the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma.

08.11.08

1656

Deferasirox Tablet for Oral Suspension (Additional Sosage Form)

Same as approved

14.12.10

1657

Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. Indication)

1) As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 2)As an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C tÞ¡

08.11.08

1658

Memantine ER Tablet 7mg/14mg/21mg. (Additional Strength)

Same as approved

17.12.10

1659

Paclitaxel inj.30/100/300mg vial (Addl. Indication)

For the treatment of advanced gastric carcinoma.

08.11.08

1660

Montelucast + Desloratidine(10mg + 5mg) FC Tablets

For the treatment of allergic rhinitis in adults only.

10.11.08

1661

Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before reconstitution: â?¢ 1000ml of electrolyte solution in Compartment A contains: Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm Lactic Þ¡

For treatment of acute kidney disease (renal failure), as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis.

23.12.10

1662

Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets

Additional Lower Strength.

10.11.08

1663

Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet

For Mineral & Vitamins deficiency states in adult patients.

23.12.10

1664

Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. (New Dosage Form)

For the treatment of acute inflammation conditions associated with spasm in adults only.

04.01.12

1665

Aspirin delayed release tablets

Each (aspirin) delayed release tablet contains; aspirin-325mg,500mg

06/09/1993

1666

Baclofen ER (GRS) Capsule 45mg/60mg (additional strength)

As approved.

22.02.07

1667

Beclomethasone Dipropionate

Each metered dose contains; Beclomethasone Dipropionate-50mcg

1975-December

1668

Bisacodyl

Laxative.

1962- June

1669

Bleomycin

Bleomycin-5mg

Cancer specialists

1978-October

1670

Bupropion hcl

Each SR tablet contains; bupropion hcl-150mg

Indicated as an aid to smoking cissation treatment.

10/04/2001

1671

Celiprolol hydrochloride tablets and Bulk

Each film coated tablet contains; celiprolol hydrochloride-100mg, 200mg, 400mg.

Mild to moderate hypertension, angina pectoris.

01/12/1994

1672

Centbutindole bulk

Neuroleptic agent

1986-December

1673

Centpropazine caps

Each cap contains; centpropazine-20mg

In the treatment of depression.

16/08/1996

1674

Cetrizine + Pseudoephedrine tabs

Each film coated tab contains; cetrizine dihydrochloride-5mg(immediate release), pseudoephedrine hcl-120mg (SR)

09/09/1997

1675

Clobetasol propionate cream/ointment

Clobetasol propionate-0.05%

Topical corticosteroid.

1987-October

1676

Danofloxacin mesylate injection

Each ml contains; danofloxacin mesylate eq.to 25mg of danofloxacin.

Bovine respiratory disease in beef cattle; non lactating dairy cattle calves caused by pasteurella haemolytica, p. Multocida & enteric infection caused by E.coli/salmonella

12/08/1995

1677

Desogestrel + ethinyl estradiol

Each pack of 22 tabs consists of 7 blue tabs of desogestrel-0.025mg, EE-0.04mg, 15 white tabs of desogestrel-0.125mg, EE-0.03mg

For oral contraceptive in women only

29-05-2000

1678

Desvenlafaxine (as Succinate) ER TabletsÂ 50mg/100mg

Each uncoated ER tablet contains; desvenlafaxine succinate eq.to desvenlafaxine-50mg, 100mg

For the treatment of major depressive disorder (MDD).

20.07.09

1679

Dexamethasone + indomethacin

Each capsule contains; Dexamethasone-0.125 mg, indomethacin-25 mg

1971- November

1680

Dextrochlorpheniramine maleate

tablet-2mg, syrup-each 5 ml=2mg

1969- Februaryy

1681

Enalapril maleate tablets

Each tablet contains; enalapril maleate-2.5mg,5mg,10mg,20mg

All grades of hypertension.

1989-August

1682

Eribulin mesylate solution for injection 0.88mg in 2ml vial (Add. Indication)

For the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvantÞ¡

18.02.15

1683

Fluconazole tablets

400mg

Additional strength

2004-April

1684

Fluorescein Sodium Solution for Injection (100mg/ml)

Ophthalmological diagnostic agent.

02/03/2006

1685

Fosaprepitant (as Dimeglumine) for Injection 150mg.

Each vial contains; fosaprepitant dimeglumine eq.to fosaprepitant-150mg

1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. 2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

16.12.11

1686

Gemcitabine HCl injection ready to use infusion bags (Approved as infusion bags)

Gemcitabine HCL equivalent to Gemcitabine 10mg per mL (100,120,130,140,150,160,170,180,190 and 200mL)

Ovarian cancer-Gemcitabine injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has replaced at least 6 months after completion of platinum based therapy. Breast Cancer-Gemcitabine injectioÞ¡

17.06.14

1687

Glydiazinamide

Oral hypoglycemic acid- indicated in the treatment of diabetes.

1976-February

1688

Iodamide

300/350

300-intravenous urography, 350-angiocardiography.

1967- October

1689

Itrolan 190, 240, 300 injection.

Itrolan 190-1ml contains; 0.406g of itrolan, Itrolan 240-1ml contains; 0.513g of itrolan, Itrolan 300-1ml contains; 0.641g of itrolan.

Contrast media

23/10/1992

1690

Levetiracetam (250mg,500mg,750mg) tablets

Each film coated tablet contains; levetiracetam-250mg, 500mg, 750mg

By neurologists- As adjunctive therapy in treatment of partial onset of seizures in adults with epilepsy.

05/04/2005

1691

Lincomycin + Spectinomycin sterile solution

Each ml contains; Lincomycin hcl-50mg, spectinomycin sulphate-100mg

1988-October

1692

Marantel Tartrate

1973-August

1693

Melitracen + Flupenthixol tablets

Each sugar coated tab contains; flupenthixol dihydrochloride eq.to flupenthixol-0.5mg, meltracen hcl eq.to melitracen-10mg

Psychogenic depression, depressive neurosis, marked depression and psychosomatic affections accompanied by anxiety and apathy.

28/10/1998

1694

Menadione sodium bisulphate

1mg/0.5ml

06/08/1999

1695

Methaqualone hydrochloride

150 mg

A new non-barbiturate Hypnotic.

1961- April

1696

Miconazole Active Substance

Topical antifungal and anti bacterial agent- for the treatment of onychomycosis, dermatophytosis and vulvovaginitis.

1974- December

1697

Mitomycin-C

Each vial contains; Mitomycin-C-2mg

1972-December

1698

Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional Indication)

For the prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplantation.

23.01.08

1699

Nadolol tablets

Each tablet contains; nadolol-40mg,80mg

Anti hypertensive agent- Indicated in the treatment of angina pectoris, cardiac arrhythmias and essential hypertension.

1985-September

1700

Neomycin + Bacitracin + Polymixin B Sulphate

1977-November

1701

Prenoxdiazine hcl.

Each tab contains; prenoxdiazine hcl-100mg

Anti tussive agent- Indicated in relief of cough of bronchial origin.

1990- July

1702

Propanidid

Each 10ml contains; 0.5gm propanidid

1970- July

1703

r-follinotropin beta soln for inj.in cartridges

Each cartridge contains; r-follinotropin beta-300Iu,600IU

Additional strength.

21-02-2002

1704

Rowachol capsules

Each cap. Contains; pinene-17mg,camphene-5mg,cineol-2mg,methone-6mg,menthol-32mg,borneol-5mg,olive oil-33mg

For hepato-billiary disorders.

1991- September

1705

S(-) amlodipine + atenolol tab

Each tab contains; atenolol-50mg, S(-) amlodipine-2.5mg

For treatment of essential hypertension & angina pectoris.

25-03-2003

1706

Sarcolysin

Russian pharmacopoeia drugs

1965- April

1707

Telmisartan IP 80mg + Hydrochlorothiazide IP 25mg uncoated bilayered tablet (Additional Strength)

For the treatment of hypertension as second line therapy.

14.05.13

1708

Tetracycline Hcl

Each Sustained release capsule contains; Tetracycline Hcl-250mg

1979-August

1709

Tylosin Tartrate

Antimicrobial- Aid in the treatment of chronic respiratory disease in chicken and for maintaining weight gain and feed efficiency in Turkey.

1980-May

1710

Zileuton uncoated bilayered extended release tablet ...600mg

Each uncoated bilayered extended release tablet contains; zileuton-600mg

For the prophylaxis and chronic treatment of asthma in adults.

30.09.10

1711

Losartan + Hydrochlorthiazide (100 mg + 25 mg) Tablets

Additional Strength.

10.11.08

1712

Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet

Additional strength

29.12.10

1713

Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v Solution

Surgical hand scrub & healthcare personnel hand wash.

29.12.10

1714

Phenyramidol HCl tablet 400mg

Each film coated tablet contains; phenyramidol Hcl-400mg

For the treatment of lumbago, integumental pain, musculoskeletal pain.

18.11.08

1715

Salicylic Acid + Coal Tar (3% + 1%) Solution

For scaling of seborrhea, seborrheic dermatitis, psoriasis of scalp.

17.11.08

1716

Streptococcus faecalis T-110 JPC 30 million + Clostridium butyricum TOA 2 million + Bacillus mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules

For restoration of intestinal microflora.

15.03.10

1717

Amisulpride 50/100/200 and 400mg Tablets

Each tablet contains; amisulpride-50mg, 100mg, 200mg and 400mg

For acute and chronic schizophrenic disorders, in which positive and negative symptoms are prominent, including patients characterised by predominant negative symptoms, schizophrenic disorder.

12.03.10

1718

Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment

For the treatment of psoriasis and fungal skin infection.

17.11.08

1719

Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets

For the acute treatment of inflammatory musculoskeletal disorders associated with painful muscle spasm in adults.

17.11.08

1720

Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) Capsules

Additional Lower Strength.

17.11.08

1721

Calcium Hypochlorite 4gm Sachet (Calcium Hypochlorite 0.542% Other Ingredients: 99.458%)

Each 4g sachet contains; calcium hypochlorite-0.542%, other ingredients-99.458%

For purification of contaminated ground water sources.

20.11.08

1722

Sumatriptan + Naproxen (50mg + 275mg) Tablets

Additional Lower Strength.

24.11.08

1723

Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC Tablets

For the treatment and management of patients with community acquired pneumonia or acute bacterial sinusitis due to beta lactamase producing pathogens.

25.11.08

1724

Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets

Additional Lower Strength.

02.12.08

1725

1,2-dimethyl-3 hydroxypyrid-4-one caps

Each capsule contains; 1,2-dimethyl-3 hydroxypyrid-4-one-250mg, 500mg.

07/12/1994

1726

5-Fluorouracil

5-Fluorouracil-250mg

1977-December

1727

Abiraterone acetate Tablet 250 mg (Additional Indication)

For the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated, with prednisone or prednisolonÞ¡

27.03.15

1728

Abiraterone Acetate Tablets 250mg

Each tablet contains; abiraterone acetate-250mg

In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel.

16.12.11

1729

Alprazolam SR tab (1.5mg)

SR tablets-1.5mg

Short term symptomatic treatment of anxiety including anxious patients with symptoms of depressions.

1997

1730

Amlodipine (As besylate) 5mg/10mg + Perindopril 4mg tablet

For hypertension.

23.02.07

1731

Atricurium dibesylate injection

Muscle relaxant- Indicated for use in anaesthesia to relax muscle during surgical procedures and to facilitate controlled ventillation.

1986-January

1732

Benidipine hcl tabs

Each film coated tab contains; benidipine hcl-4mg,8mg

Hypertension and long term prophylactic management of angina pectoris.

12/08/1996

1733

Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Indication)

In the regular treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with frequent symptoms and a history of exacerbations.

04.01.12

1734

Carboxy Methyl Cellulose Sodium Lubricant Eye Drops 0.5% w/v (Unit dose pack without preservative)

For temporary relief from burning irritation and discomfort due to dryness of the eye or due to exposure to wind or sun. May also be used as a protectant against further irritation.

27.05.13

1735

Cefditeron (as pivoxil) 200mg tablet

Anti-biotic

03/03/2006

1736

Cephalexin ER tabs

Each ER film coated tablet contains; cephalexin IP eq.to cephalexin anhydrous-375mg,750mg

17/11/1998

1737

Cephalexin tablets

1 gm cephalexin

1988-October

1738

Chlophedianol hydrochloride

Antitussive

1961- April

1739

Cimetidine

tablet-200mg, injection 100mg/mL and syrup-200mg/5mL

Anti-ulcer, indicated for treatment of benign gastric , duodenal, recurrent and stomal ulceration, reflex oesophagitis only

1980-May

1740

Clobetasol propionate bulk

1987-October

1741

Clopidol

Coccodiosis

1972-January

1742

Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IU.

For the treatment of osteoporosis in post-menopausal women.

23.01.08

1743

combikit of pioglitazone & metformin tab

Each combikit contains; one tab of pioglitazone hcl eq.to pioglitazone-15mg, two tab of metformin hcl-500mg

Patients with type-II diabetes mellitus when diet, exercise & the single agent do not result in adequate glycemic control.

18/02/2002

1744

Dicloxocillin Sodium

Dicloxocillin Sodium eq to 125mg & 250mg of Dicloxocillin

1979-August

1745

Loperamide

Anti diarrhoeal agent- indicated in the treatment of acute diarrhoea due to food poisoning, viral infections.

1976-December

1746

Esomeprazole Sodium For injection

Each vial contains; esomeprazole sodium eq.to esomeprazole-40mg

For GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral in take is not appropriate.

05/04/2005

1747

Extraxt of mycobacterium vaccal

Each injection contains; extract of mycobacterium vaccal eq.to 100mg/ml proteins

Indicated in the sterilization castration of male animals (dogs,cattle,buffalo, bulls).

1990- August

1748

Ferrous sulphate + Folic acid CR tablets

Each CR tablet contains; ferrous sulphate CR-100mg (eq.to elemental iron), Folic acid-0.5mg.

For the prophylaxis of iron and folic acid deficiencies during pregnancy.

03/11/1992

1749

Fluconazole

Each 5ml contains; fluconazole-50mg

For systemic candidiasis, mucosal candidiasis, cryptocosis, prevention of fungal infection in patients with malignancy.

29-05-2000

1750

Fluocortolon Trimethyl acetate + Fluocortolone caproate + Clenizole undecyclate + Cinchocaine Hcl

Ointment-Each gm contains; Fluocortolon Trimethyl acetate-0.92mg, Fluocortolone caproate-0.95mg, Clemizole undecylate-10mg, Cinchocaine Hcl-5mg, Suppositories-Fluocortolon Trimethyl acetate-0.612mg, Fluocortolone caproate-0.630mg, Clemizole undecylate-5mgÞ¡

1978-October

1751

Haemmacel

500 ml bottles

Blood plasma substitute

1965- May

1752

Halcinonide

Topical cream- indicated in the treatment of various common dermatosis.

1976-July

1753

Hydrocortisone (10%) enema form

10% w/w

For adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients of ulcerative colitis & proctosigmoditis.

09/08/1999

1754

Hydroxyurea tablets

1000mg

2004-April

1755

Isocarboxacid

Tabs 10 mg

Anti-depressant.

1962- June

1756

Isosorbide dinitrate

10mg & 5 mg

Coronary vasodilators.

1967- October

1757

Lisinopril

Each tablet contains; lisinopril dihydrate eq. to 10mg,20mg of lisinopril, 2.5mg,5mg approved vide letter dated 22.11.91

Essential hypertension and inpatients with congestive heart failure.

1991- November

1758

Lubiprostone soft gelatin capsules 8mcg / 24 mcg

Each soft gelatin capsule contains; lubiprostone-8mcg, 24mcg

1. For the treatment of chronic constopation in adults. 2. For the treatment of irritable bowel syndrome with constipation (IBS-C) in women > 18 years old.

19.10.10

1759

Lynestrenol + Ethinyloestradiol

Each tablet contains; Lynestrenol-1mg, Ethinyloestradiol-50mcg

Oral contraceptive.

1973-September

1760

Meloxicam gel (1% w/w)

Each gm contains; meloxicam-10mg

For acute painful/inflammatory musculoskeletal painful conditions.

09/04/2001

1761

Methenolone acetate

i)-Tablet-each contains; metenolone acetate-5mg, ii)-Depot-each 1ml of solution contains; metenolone enanthate-100mg

1970- July

1762

Metolazone tab USP

Each uncoated tab contains; metolazone USP-2.5mg,5mg,10mg

For treatment of hypertension & oedema accompaying CHF & renal failure.

23-04-2003

1763

Miconazole Cream

1974- December

1764

Nitrendipine + Atenolol tabs

Each tab contains; nitrendipine-10mg,20mg, atenolol-30mg

Mild to moderate hypertension not responding to monotherapy with either of the drug.

19/09/1995

1765

Pheniramine maleate

Each retard tablet contains; pheniramine maleate.

1971- November

1766

Piperacillin sodium injection

Each vial contains; piperacillin (as sodium salt)-1gm,2gm, (19-2-90)-3gm,4gm

Antibiotic- Indicated in the treatment of systemic and local infections, peri-operative infections, prophylaxis & obstructive and gynae infections, UTI, neonatal and life threatening paediatric infections.

1989-August

1767

Piribedil SR Tablets

Each SR coated tablet contains; piribedil-50mg

Of imapired attentiveness and/or memory or feelings of giddiness in elderly, painfull symptoms of arterial disease, idiopathic parkinson disease.

27/09/1993

1768

Posaconazole Oral Suspension 40mg/ml

For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.Â For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk Þ¡

18.07.09

1769

Tadalafil Orally Disintegrating Strip 10mg & 20mg (Additional dosage form)

For erectile dysfunction.

30.07.14

1770

Testosterone undecanoate capsules

Each capsule contains; testosterone undecanoate-40mg

Oral androgen- Indicated for replacement therapy in cases of hypergonadism and male climacteric in the treatment of gynaecomastia.

1985-September

1771

Thiethylperazine dimalate

Tablet-10.28mg of thiethylperazine dimalate, ampoule- Each ml contains; 10.86mg thiethylperazine dimalate

1969- Februaryy

1772

Virginiamycin obtained from streptomyces virginiae

Antibiotic- Indicated for growth propotion in poultry pigs and for prevention & treatment of swine dysentry.

1975-February

1773

Atorvastatin + Metformin(10mg + 500mg SR) Tablets

As adjunctive therapy to diet and exercise in patients with diabetic dyslipidemia.

04.12.08

1774

Pemetrexed disodium 500mg / 100mg powder for sol. (Addl. Indication)

As monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

04.12.08

1775

Meglumine iocarmate

X-ray contrast media.

1974-February

1776

Magnesuim Valproate Tablet 200mg/400mg

Each enteric coated tablet contains; magnesium valproate-200mg, 400mg

05.12.08

1777

Ursodeoxycholic Acid 300/600 SR Tablets (Additional Strength)

For the dissolution of Radiolucent collestral goll stone, chronic cholestatic liver disease in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cyatic fibrosis.

08.12.08

1778

Rifampicin + Isoniazid + Piperine (200mg + 300mg + 10mg ) Capsules

For the treatment of adult patients with pulmonary tuberculosis.

11.12.08

1779

Rifampicin + Piperine (200mg + 10mg ) Capsules

For the treatment of adult patients with pulmonary tuberculosis.

11.12.08

1780

Amphotericin B Lipid suspension 50mg/ vial (Addl. Strength)

Additional Strength.

12.12.08

1781

Desmopressin Acetate tablet 0.1/0.2 mg

For the treatment of cranial diabetes insipidus , primary noctumal enuresis in patients.

12.12.08

1782

Mifepristone + Misoprostol (1 tab of mifepristone 200mg and 4 tab of misoprostol 200mcg) Combipack

For the medical termination of intrauterine pregnancy (MTP) of up to 63 days gestation based on the first day of the last menstrual period.

16.12.08

1783

Lamotrigine MR Tablets 50/100mg

For the treatment of bipolar I disorder. (addl. Indication).

17.12.08

1784

3,5 - Dinitro-O-toluamide

1972-January

1785

Aceclofenac injection 150mg/ml

For short term treatment of pain due to post operative and post traumatic cases.

23.01.08

1786

Ambodryl + Aspirin + Phenacitin + Caffeine + Phenylephrine hcl + Aluminium hydroxide

Ambodryl-10mg, Aspirin-190mg, Phenacitin-65mg, Caffeine-15mg, Phenylephrine hcl-10mg, Aluminium hydroxide gel-100mg

Upper respiratory tract infections

1970- November

1787

Amitriptyline hydrochloride

tabs 10 & 25 mg, inj. 10mg/cc

Anti-depressant.

1962- August

1788

Amoxycillin 3H2O dispersible tablets

Each dispersible tablet contains; 200mg,400mg

26-05-2000

1789

Baclofen tablets

Each tab contains; baclofen USP-10mg, 25mg.

29/09/1995

1790

Carbonyl iron (MR) + folic acid + Vitamin B12

Each film coated tablet contains; elemental iron (as carbonyl modified release)-45mg, folic acid-1.5mg, vitamin B12-15mcg

By RMP- for the treatment of nutritional iron deficiency anemia in adults only

19/04/2004

1791

Celecoxib cap

For additional indication of management of acute pain in adults & primary dysmenorrhea.

15-02-2002

1792

Cohorton ointment

1965- May

1793

Combipack

i)-Omeprazole-20mg cap + Clarithromycin-250mg tab + Tinidazole-500mg tab, ii)-Omeprazole-20mg cap + Amoxycillin-750mg tab + Tinidazole-500mg tab

For eradication of H.pylori associated with peptic ulcer.

09/09/1997

1794

Crizotinib hard gelatin Capsules 200mg/250mg

Each hard gelatin capsule contains; crizotinib-200mg, 250mg

For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) â?? positive as detected by an FDA-approved test.

16.12.11

1795

Dextranomer bulk

1985-September

1796

Diazepam

Each mL contains; Diazepam-5mg

1977-December

1797

Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard Gelatin Capsules. (New Dosage Form)

For the treatment of Patients with acute musculoskeletal spasm associated with low back pain.

06.01.12

1798

Dioctyl Sodium Sulfosuccinate

Dioctyl Sodium Sulfosuccinate USP-5%

1979-September

1799

Eicosapentaenoic acid + Docosahexaenoic acid capsules

Each capsule contains; Eicosapentaenoic acid-180mg, Docosahexaenoic acid-120mg

1989-September

1800

Extract of Centella Asiatica

Indicated in the treatment as ulcers, burns, skin grafts, keloids, bed sore etc.

1975-February

1801

Finasteride

1mg

Additional indication- in treatment of male pattern hair loss in men only.

23-04-2001

1802

Gliclazide tablets

Each tablet contains; gliclazide-80mg

Anti diabetic- Indicated in the treatment of all types of maturity onset diabetes, diabetes without or with obesity in adults.

1988-November

1803

Hydroxychloroquine Sulphate USP 400 mg tablets (Additional Indication)

As an adjunct to diet and exercise to improve glycemic control of patients on metformine, sulfonylurea combination in patients with Type II Diabetes.

28.07.14

1804

Hyper immune rabies serum

Potency 1.20 I.U/ml

1969- March

1805

Indomethacin Injection 1mg/vial (additional Dosage form)

To close a hemodynamically significant patent ductus arteriosus (PDA) in premature infants weighing between 500g and 1750g when after 48 hrs. usual medical management (e.g. fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffectiveÞ¡

30.04.15

1806

Lansoprazole capsules

Each capsule contains; lansoprazole-30mg(as enteric coated granule), lansoprazole(as enteric coated granule)-15mg(31-7-96)

For the treatment of duodenal ulcer, gastric ulcer, reflux oesophagitis, zollinger-ellison syndrome.

16/12/1994

1807

Levamisole + Oxyclozanide suspension

Levamisole-1.5%, oxyclozanide-3.0%

29/09/1993

1808

Haloperidol

1969- March

1809

Montelukast sod.+ bambuterol hcl tab

Each film coated tab contains; montelukast sod.eq.to montelukast-10mg, bambuterol hcl BP-10mg,20mg, montelukast-5mg+bambuterol-5mg, montelukast-5mg+bambuterol-10mg

For treatment of chronic asthma.

10/04/2003

1810

N-acetyl-sulphamethoxy pyridiazine

Long acting sulpha drug similar to Lederkyn. It is tasteless and more acceptable to children.

1961- April

1811

Naratriptan (as HCl)Â Tablets 1/ 2.5mg

Each film coated tablet contains; naratriptan hydrochloride USP eq.to naratriptan-1mg, 2.5mg

For the acute treatment of migraine with or without aura in adults.

21.07.09

1812

Nitrazepam

Each tablet contains; Nitrazepam-5mg

1973-September

1813

Ofloxacin eye drops

Each ml contains; ofloxacin-3mg.

In tropical treatment of external infections of the eye and its adnexa caused by susceptible bacteria.

1991- December

1814

Olopatadine Hcl. Tablet 2.5mg/5mg

Allergic nasal inflammation hives, itching with skin diseases.

26.02.07

1815

Pazopanib (as Hydrochloride) film coated Tabletsâ?¦200mg / 400mg

Each film coated tablet contains; pazopanib hydrochloride 216.7mg, 433.4mg eq.to pazopanib-200mg, 400mg

For the treatment of patients with advanced renal cell carcinoma.

19.10.10

1816

Pipecuronium bromide inj.

Each vial contains; freeze dried pipecuronium bromide-4mg.

Non depolarising muscle relaxing agent- In the treatment of as an adjunct to general anesthesia to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgical procedure of medium and large duration.

03/11/1992

1817

Prochlorperazine maleate

Each buccal tab contains; active drug-3 mg.

For treatment of nausea, vomiting, post operative emesis & migrains.

09/08/1999

1818

Propoxyphene napsylate BP + Paracetamol IP

Propoxyphene napsylate BP-100mg, Paracetamol IP-650mg

1978-November

1819

Reproterol tablet/elixir

Tablet-reproterol hcl-20mg, Elixir-reproterol hcl-10mg/5ml

1987-October

1820

Rupatadine (10mg) tablet

Each tablet contains; rupatadine fumerate eq.to rupatadine-10mg

For the symptomatic treatment of seasonal perinial allergic rhinitis.

05/04/2005

1821

Sildenafil Citrate Orally Disintegrating Strips. 25mg/50mg (Additional Dosage Form)

For the treatment of erectile dysfunction.

05.07.13

1822

Sodium Hyaluronate Cream 0.2%

For leg ulcer, diabetic ulcer etc.

16/03/2006

1823

Sulprostone injection

Abortificient- For second trimester abortion only.

1986-January

1824

Tamoxifen citrate

Breast cancer in pre & post menopausal women.

1980-June

1825

Terfenadine

Each tablet contains; terfenadine-30mg,60mg,120mg, suspension-30mg/5ml

Anti histamine- Allergic rhinitis, allergic dermatological conditions and other histamine mediated disorders.

1990- September

1826

Vernase

Acid-stable digestive multienzyme.

1967- November

1827

Yeast-Tannic acid + iodochloro hydroxy quinoline + benzal bronium chloride

Each tablet contains; Yeast-Tannic acid compound (Eldoform)-250 mg, iodochloro hydroxy quinoline-150mg, benzal bronium chloride-10mg

Anti-diarrhoeal agent.

1971- November

1828

Zidovudine tab

300mg

Additional strength for HIV.

18/12/1998

1829

Zopiclone

Each tab contains; zopiclone BP-7.5mg

Short term treatment of insomnia, transient, situational or chronic insomnia and insomnia secondry to psychiatric disorders where it is desilitating or severe.

16/08/1996

1830

Levosulpride Injection 25mg/2ml (Additional Strength)

For the treatment of different Gastro intestinal problems like functional dyspepsia, nausea, vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults.

17.12.08

1831

Cyclobenzaprine HCl ER Capsule 15/30mg

As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions.

17.12.08

1832

Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml (Additional Indication)

In combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

17.12.08

1833

Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion

For the treatment of scaly dermatoses.

18.12.08

1834

Azathioprine 25mg Tablets

Additional Strength.

19.12.08

1835

Paracetamol solution for infusion 10mg/ml

Each 100ml contains; paracetamol-10mg/ml

For short term treatment of moderate pain, especially following surgery and for the short term treatment of fever, when administration by i.v route is clinically justified.

24.12.08

1836

Gemifloxacin + Ambroxol (320mg + 75mg SR) FC Tablets

Indicated for the treatment of lower respiratory tract infections in adult patients.

24.12.08

1837

Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection

1. For LRTI infections, 2. for UTI - Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic infections including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. fÞ¡

24.12.08

1838

Paracetamol + Phenylephrine Hydrochloride (Each 6gm Sachet contains: 500mg + 10mg) Sachet

For the treatment of fever associated with cold, nasal congestion in adults.

24.12.08

1839

Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrup

For symptomatic treatment of cough.

24.12.08

1840

3-Methyl pyrantel tartrate

Anthelmintic

1970-April

1841

Acesulfame Potassium

As sweetener in pharmaceutical preparation.

05/04/2005

1842

Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication)

For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions.

25.01.08

1843

Botulinum toxin type-A i.m injection

Each vial contains; clostridium botulinum toxin type A-hemagglutinin complex 100 units, human serum albumin-0.5mg, NaCl-0.9mg

For the treatment of blepharospasm hemifacial spasm associated focal dystonias.

13/01/1994

1844

Cefovecin (as sodium) 80mg/ml Lyophilised powder for injectionÂ (Veterinary)

Each ml contains; cefovecin sodium eq.to 80.0mg cefovecin

For the treatment of skin bacterial infections in dogs and cats.

07.10.09

1845

Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension per 10 gm Intramammary Suspension

For the treatment of clinical mastitis in lactating dairy cows for bacteria susceptible to the combination of cephalexin and kanamycin such as Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus uberis and Escheria coli.

07.03.12

1846

Chlormezanone

Tabs-100 mg

Muscle relaxant & tranquiliser.

1962- August

1847

Cisapride tablets

Each tablet contains; cisapride-5mg,10mg,20mg-(24-8-94), Each 1ml suspension contains; cisapride-1mg.

Gastro intestinal disorders- Oesophagitis and gasto oesophageal reflux disorders, chronic functional and non ulcer dyspepsia, gastroparesis intestinal pseudo obstruction and constipation.

06/11/1992

1848

Clomiphene Citrate B.P

50mg (1 tablet) daily for 5-days on or about 5 day of the cycle.

Fertility drug- induction of ovulation in patients with persistant ovulatory dysfunction who desire pregnancy.

1974-February

1849

Clonidine + Chlorthalidone

Each tablet contains; Clonidine hcl BNF-0.1mg, 0.2mg, Chlorthalidone IP-15mg

1977-December

1850

Clonidine Hcl

Antihypertensive agent- indicated in the treatment of hypertension.

1975-February

1851

Cytarabine

Anticancer indicated in the treatment of acue myeloid leukaemia

1980-June

1852

Dextranomer sachet

Each sachet contains; dextranomer-4gm,60gm

Ulcer & burn- In cleansing secreting wounds like venous stasis ulcers, decubitus ulcers, infected traumatic ulcers & infected burns.

1985-September

1853

Dextromethorphan Hydrobromide Extended Release suspension 30mg/5ml (Additional Dosage Form)

For the relief of persistent dry irritating cough in adults patients only.

01.08.13

1854

Diclofenac dispersible tablets

Each dispersible tablet contains-46.5mg of diclofenac free acid eq.to 50mg of diclofenac sodium.

30/09/1993

1855

Divalproex sodium tablets

For additional prescription condition to be sold under Neurologist & Psychiatrist only.

21/04/2004

1856

DPT Acthi B Vaccine

1998-January

1857

Eltrombopag (as Olamine) Tablets ...25mg / 50mg

Each film coated tablet contains; eltrombopag olamine eq.to eltrombopag as free acid-25mg, 50mg

For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (It should be used only in patients with ITP whose degreÞ¡

19.10.10

1858

Enalapril maleate bulk

1989-September

1859

FDC of rosiglitazone + metformin

Each tab contains; rosiglitazone-4mg, metformin-500mg

Additional strength.

21-02-2002

1860

Fibrinolysin (human)

50000-100000 Units

To promote the dissolution of intravenous thrombi.

1961- April

1861

Fluphenazine Decanoate

Each mL contains; Fluphenazine Decanoate-2mg

1973-September

1862

Injection of iron sorbitol citric acid complex

1967- November

1863

Ketorolac ODS 10mg (Additional Dosage form)

For the treatment of short-term management of post-operative pain and musco-skeletal pain.

29.04.15

1864

Lovastatin

Each tab contains; lovastatin-10mg,20mg,40mg.

Reduction of total LDL cholestrol in patients of primary hypercholesterolemia (type-IIa & IIb hyperlipoproleinemia)

05/10/1995

1865

Loxapine

Each capsule contains; loxapine succinate-5mg,10mg,20mg,50mg of base, loxapine oral concentration solution eq.to 25mg/ml.

Anti depressant- For the management of the manifestation of psychotic disorders.

1990-September

1866

Marek's disease vaccine T.H.U Living

1972-April

1867

Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg

Essential hypertension.

26.02.07

1868

Metronidazole

Each mL contains; Metronidazole IP-2mg

1978-November

1869

Nevirapine Extented release tablet 400mg

Each uncoated extended release tablet contains; Nevirapine IP 400mg

For use in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults.

01.07.14

1870

Norlestrin tab

1965- May

1871

Horse anti human lymphocyte globulin

For aplastic anaemia.

1991- May

1872

Omega-3 acid ethyl ester capsules (Bulk)

Each capsule contains; omega-3 acid ethyl esters (90%) 1000mg comprising [eicosapentaenoic acid (EPA) ethyl ester-460mg + docosahexaenoic acid (DHA) ethyl ester-380mg]

16.03.11

1873

Omniclean

Alkyl dimethyl benzyl ammonium chloride-5%, nonyl phenol ethoxide-6%, inert ingredient-89%

Disinfectant preclean.

23-08-1999

1874

Pantoprazole

Each vial contains; pantoprazole sod. Eq.to pantoprazole-40mg

Deodenal ulcer, gastric ulcer, moderate and severe reflux oesophagitis.

07/06/2000

1875

Paracetamol SR tabs

Each SR tab contains; paracetamol-650mg

1996

1876

Praziquantel tablets

Neurocysticercosis- In the treatment of infections brought about the larvas of the pork tapeworm in the central nervous system.

1986-February

1877

Propranalol Hcl.

Each tablet contains; proppranolol hcl-10mg, Each ml contains; propranolol hcl-1ml

1971- November

1878

Quinidine phenylethyl barbiturate

0.1 g

1969- March

1879

Rabbit anti human thymocyte immunoglobulin

1991- May

1880

Reproterol respirator solution/aerosol/injection

Respirator solution-10mg/ml, Aerosol-each metered dose-0.50mg, Injection-0.09mg/ml (Reproterol hcl)

1987-October

1881

Salinomycin premix

Salinomycin sodium-6%

Prevention of coccidiosis.

1988-December

1882

Saquinavir (500mg) tablet (addl. Strength)

Anti-AIDS

20/03/2006

1883

Serenoa repens caps.

Each soft gelatin cap contains; 160mg lipid extract of serenoa repens.

For BPH.

12-09-1997 to 12-09-1999

1884

Silver Sulphadiazine

Silver Sulphadiazine-1%w/w

Antibacterial agent- indicated in the treatment of burn & wound infections.

1979-September

1885

Tranexamic acid tablets/inj.

Additional indication-abnormal bleeding in which local hyperfibrinolysis is considered to be involved (pulmonary, haemorrhage, epistaxis, renal bleeding abnormal bleeding during or after prostate surgery).

06/06/2003

1886

Ursodeoxycholic acid

Each tablet contains; 300mg

Earlier strength approved was 150 mg.

12/04/2001

1887

Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules

Additional Lower Strength.

24.12.08

1888

Budesonide

Each CR capsule contains; budesonide (CR)- 3mg

For the treatment of ulcerative colitis.

17.06.08

1889

Faropenem

Each film coated tablet contains; faropenem sodium eq.to faropenem-200mg

For the treatment of upper and lower respiratory tract infection, urinary tract infection and skin & skin structure infection.

16.04.08

1890

Paclitaxel albumin bound particles for injectable suspension

Each vial contains; paclitaxel-100mg, Human serum albumin-q.s

For the treatment of breast cancer afetr failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

18.08.08

1891

Amino acid injection

As parenteral nutrition, when oral, enteral nutrition is impossible, insufficient or contraindicated.

18.08.08

1892

Hyaluronic acid sodium salt injection

1) Each vial contains; hyaluronic acid sodium salt-20mg/2ml, 2) Each 2ml pre-filled syringe contains; hyaluronic acid sodium salt-20mg

For relief of pain in patients with osteoarthritis of the joint who have failed to respond adequately to convetional therapy.

01.10.08

1893

Moxifloxacin eye ointment

Each gram contains; moxifloxacin hydrochloride eq.to moxifloxacin base-5mg

For the treatment of bacterial conjunctivitis caused by susceptible organisms.

01.10.08

1894

Tacrolimus lipid suspension for injection

Each vial contains; tacrolimus monohydrate eq.to tacrolimus-5mg

For prophylaxis of transplant rejection in liver, pancreas, lung, heart and kidney allograft recipients. And treatment of allograft rejection resistant to treatment with other immuno suppressive medicinal products.

15.10.08

1895

Hyaluronic acid pre-filled syringe

1) Each 0.6ml preifilled syringe contains; hyaluronic acid sodium salt-11mg, 2) Each 1ml pre-filled syringe contains; hyaluronic acid sodium salt-20mg

For cutaneous rejuvenation and for providing medium lasting correction of cutaneous contour deficiencies.

13.10.08

1896

Hyaluronic acid pre-filled syringe

Each 1ml pre-filled syringe contains; auto across linked hyaluronic acid-20mg

For a medium lasting corrective action on minor soft tissue defects such as facial fine lines.

13.10.08

1897

Aclarubicin hydrochloride injection

Anti cancer- Indicated in the treatment of acute leukaemia, malignant lymphoma, stomach, lung cancer etc.

1988-March

1898

Amylase + cellulose + protinase + pancreatic enzyme + lipase

Each capsule contains; Amylase, cellulose, protinase, pancreatic enzyme, lipase

1971- December

1899

Bethanidine sulphate

10 & 50 mg tablets

1969- March

1900

Bromhexine Hcl

Each tablet contains; Bromhexine Hcl 8mg, Elixir-Each 5mL contain Bromhexine Hcl 4mg

Mucolytic agent- indicated in the treatment of brochitis and other conditions where sputum is troublesome.

1979-September

1901

Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet

For opioid dependence.

06/04/2005

1902

Buspirone hcl

Each tablet contains; 5mg,10mg of base

Anxiolytic- Indicated in the treatment of anxiety and tension states.

1990- October

1903

Calcium dobesilate caps

Each cap contains; calcium dobesilate-500mg

Chronic venous insufficiency of lower limbs only.

22-09-1997 to 22-09-1999

1904

Cerebrolysin solution for injection.

Each ml contains: Porcine brain derived peptide preparation (Cerebrolysine concentrate) 215.2mg

For amelioration of cranial injury, cerebrovascular pathological sequelae and aprosexia in dementia.

25.07.14

1905

Chloramphenicol palmitoyl glycolate

1961- May

1906

Chlordantoin

1970-August

1907

Clemastine tablet/Elixir

Each tablet contains; clemustine (as the hydrogen fumerate)-1mg, Each 5ml contains(Elixir); clemastine (as the hydrogen fumerate)-0.5mg

1985-September

1908

Desogestrel

Oral contraceptive- To be used in combination with ethinyloestradiol for contraception indicated in the treatment of gastric & duodenal ulcers.

1989-January

1909

Dobutamine hcl inj. (infusion concentrate)

Each ml contains; dobutamine hcl eq.to dobutamine-50mg

Indicated when parentral therapy is necessary for inotropic support in the short term treatment of cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical pocedures.

04/10/1993

1910

Domperidone tablets/suspension/oral drops/rectal suppositories

Tablets-10mg, suspension-1mg/ml, oral drops-10mg/ml, rectal suppositories-30mg

Anti emetic- Indicated in the treatment of gastric motality disorder etc.

1987-November

1911

Eflornithine HCl Cream (139mg/gm)

For reduction of unwanted facial hair in women.

22/03/2006

1912

Epsilon Amino caproic acid

Anti-hemorrhage

1967- November

1913

Ferric sodium citrate

1972-April

1914

Fusafungine

4 times a day for 5-10day

Fungal antibiotic- indicated in the treatment of sinusitis, pharyngitis, sore throat, laryngitis bronchitis, prevention of respitratory complication.

1977-January

1915

Gabapentin

Gabapentin-600mg,800mg

Additional strength by RMP

06/06/2003

1916

Halofuginone (derivative of an alkaloid isolated from plant Dichora Febrifuga Lour)

Poultry feed additive- for prvention & treatment of poultry Coccidiosis.

1980-July

1917

Hepatitis A Vaccine

Each 0.5ml dose contains; hepatitis A (GBM strain) virus-160 antigen unit.

For active immunization agaist infection caused by hepatitis A virus

05/02/1998

1918

Hyoscine-N-butyl bromide suppositories

Each suppositories contain hyoscine-N-butyl bromide-7.5mg,10mg

In treatment of gastrointestinal tract spasm, spasm & dyskinesia of the billiary system genito urinary tract spasm.

23-08-1999

1919

Indapamide Hemihydrate

Each tablet contains; Indapamide Hemihydrate-2.5mg

Antihypertensive- for mild to moderate hypertension.

1978-November

1920

Infectious bursal disease vaccine inactivated

Bursal disease vaccine- In the treatment of infectious bursal disease in poultry.

1986-March

1921

Isoflupredone AcetateSuspension for Injection (2mg per ml) ( For Veterinary)

For the glucocorticoid, anti-inflammatory or supportive therapy to cattle suffering from conditions such as: (1) Overwhelming infections with severe toxicity.Â (2) Bovine ketosis. (3) Musculoskeletal conditions. (4) Shock. (5) Parturient paresis (supportivÞ¡

03.10.09

1922

Isopregnenone, dydrogestrone

5 mg tabs

Oral progesterone agent.

1962- August

1923

Lactic acid with lactoserum (for topical use)

Lactic acid-0.1% w/v=1.00% w/v, lactoserum-0.9% w/v

06/11/1995

1924

Mesna oral tablets

Each film coated tab contains; mesna-400mg,600mg

By oncologist- for the prevention of urothelical toxicity including haemorrhagic cyctitis, microhaematuria and macrohaematuria in patients with ifosfamide and cyclophosphamide in doses considered to be urotoxic.

05/05/2004

1925

Niflumic acid

Anti-inflammatory drug- indicate in the treatment of rheumatoid arthritis, osteoarthritis.

1975-February

1926

Nitroxazepine Hydrochloride

Each 2mL contains; Sitamil-25mg(Nitroxazepine Hydrochloride), Each tablet contains; Sitamil-25mg(Nitroxazepine Hydrochloride)

Developed in India.

1973-September/ October

1927

Ondansetron Hydrochloride Mouth Melting Strips 4mg

For chemotherapeutic induced nausea and vomiting.

29.03.12

1928

Oxaceprol

Each capsule contains; oxaceprol-200mg

For the relief of signs and symptoms of osteoarthritis in adult patients.

15.03.11

1929

Oxcarbazepine suspension

Each 5ml contains; oxcarbazepine-300mg

Adjuntive therapy in the treatment of partial seizures in children in the age group of 4-16 years with epilepsy.

25-02-2002

1930

Pirarubicin hcl inj.

Anti cancer.

1991- May

1931

Proresid

1965- June

1932

Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer

For Duodenal ulcer, G.U, Z.E.S. & GERD.

26.02.07

1933

Raloxifene hcl

Each film coated tab contains; raloxifene hcl-60mg

For the treatment and prevention of post menopausal osteoporosis in women.

04/05/2001

1934

Cimetidine injection

Each ml contains; cimetidine hydrochloride eq.to 100mg of cimetidine

1985-September

1935

Sodium dichloro isocyanurate

Each tablet contains; active ingredient-35mg,350mg, 1.75g, 3.5g

For chlorination of drinking water

12/06/2000

1936

Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate- 750mg CR tablet (Additional Strength)

Same as Approved.

24.01.08

1937

Taurolidine 2% or 0.5%

i)-Each 100ml contains (2%); taurolidine-2g, povidone-5g, ii)-Each 500ml contains (0.5%); taurolidine-2.5g, povidone-6.25g

13/01/1994

1938

Tetrachlorodecaoxide solution

Each 100ml contains; tetrachlorodecaoxide-1.037mg.

Immuno modulator (tissue repair) of wounds with impaired healing such as infected wound, delayed post traumatic and post operative wound healing and delayed healing after operation.

06/11/1992

1939

Tiamulin hydrogen fumarate solution for injection 162 mg/ml (additional Dosage form)

For treatment and prevention of swine dysentery caused by Branchyspira hydodysenteriae. The product is not appropriate for use for the prevention of disease at the level of herd treatment but should only be used for prevention of swine dysentery in indiviÞ¡

17.04.15

1940

Tibolone tablets

Each tab contains; tibolone-2.5mg

In the treatment of complaints resulting from the natural or surgical menopause.

16/10/1996

1941

Tinidazole

150 mg t.i.d for 5days

Trichomonial agent- for the treatment of trichomoniasis & intestinal amoebiasis.

1974-February

1942

Tramadol HCL 200mg Controlled Release tablet (Additional Dosage Form)

For use in in-patients under hospital settings for severe acute pain for a period not exceeding 5 days.

12.09.13

1943

Zaltoprofen film coated tablet â?¦80mg JP

Each film tablet contains; zaltoprofen JP-80mg

For anti inflammatory and analgesic activity in rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of shoulder, cervicobrachial syndrome, postoperative, post trauma, and post dental extraction.

01.11.10

1944

Cefquinome sulphate

31.10.08

1945

Caroverine hydrochloride & Caroverine base

24.10.08

1946

Zinc gluconate

Each 5ml contains; zinc gluconate USP eq.to elemental zinc-20mg

In treatment of acute diarrhoea in children as an adjunct to oral rehydration.

04.09.08

1947

Vildagliptin Tablets 50mg/100mg

As an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes mellitus.

18.01.2008

1948

Lornoxicam 8mg /2ml inj

Each 2ml injection contains; lornoxicam-8mg

For Short-term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery)

10.04.08

1949

Adapalene + clindamycin gel

Each gm gel contains; adapalene-1mg, clindamycin phosphate eq.to clindamycin-10mg

For treatment of acne vulgaris

01/05/2003

1950

Alendronate sodium

Each uncoated tablet contains; alendronate sodium trihydrate-35mg, 70mg (as alendronic acid)

By RMP- for treatment & prevention of osteoporosis in post menopausal women.

16-05-2001

1951

Alendronate sodium tablets

Each uncoated tab contains; alendronate sodium-10mg (as alendronic acid)

Post menopausal osteoporosis only.

18-09-1997 to 18-09-1999

1952

Alphachymotrypsin

Natural endopeptidase (fungal antibiotics).

1967- November

1953

Amlodipine + Enalapril maleate tabs

Each tab contains; amlodipine-5mg,2.5mg, Enalapril maleate-5mg,2.5mg

16/11/1995

1954

Artesunate powder for injection 60mg/vial alongwith 6ml ampoule of phosphate buffer solution (pH 8.0;0.30M)

For the treatment of severe Falciparum malaria in areas where there is evidence if quinine resistance.

02.07.14

1955

Cerebroprotein HydrolysateÂ injection (Lyophilised) â?¦..1050mg / 2100mg (approx)Â Â equivalent to nitrogenâ?¦.30mg / 60mg respectively.Â

Each lyophilized vial contains; i) cerebroprotein hydrolysate 1050mg (approx) eq.to nitrogen-30mg, ii) cerebroprotein hydrolysate 2100mg (approx) eq.to nitrogen-60mg

For amelioration of cranial injury, cerebrovascular pathological sequelae and aprosexia in dementia.

09.11.10

1956

Choline Salicylate

Choline Salicylate-8.7%

1978-November

1957

Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler additional strength)

As approved.

27.02.07

1958

Dexrazoxane powder for inj (lyophilized) IV

Each vial contains; 589mg powder for inj.which corresponds to 500mg dexrazoxane base.

Prevention of cardiotoxicity of doxorubicin containing chemotherapy regimens.

26-02-2002

1959

Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet

For the treatment of acute pain in adults.

24.01.08

1960

Dicloxocillin Sodium

Dicloxocillin Sodium eq to 62.5 mg of Dicloxocillin

1979-September

1961

Doxorubicin Hydrochloride

10mg/vial

Anticancer drug- indicated in the treatment of various types of neoplasia, both acute & chronic leukaemia lymphomata, soft tissue sarcomata, breast and lung cancer.

1975- April

1962

Equine influenza & equine rhino pneumonnitis vaccine

Vaccine against inflenza, respiratory diseases, caused by ENT virus, prevention of abortion due to ENT virus infection.

1989-March

1963

FDC of Aeterolane Malate (150mg) + Piperaquine Phosphate (750mg) Tablet

Treatment of acute uncomplicated malaria infection due to Plasmodium vivax in adults.

11.10.13

1964

Gadodiamide i.v inj (finished formulation)

Each 1ml injection contains; gadodiamide 287mg eq.to 0.5 m mol (in 10ml vial)

Contrast media

21/01/1994

1965

Ipratropium bromide inhaler

Each actuation delivers; ipratropium bromide-20 mcg.

Anti chlonergic bronchodilator- Chronic obstructive bronchitis, emphysema, bronchospasm, during and after surgery and moderate to asthmatic attacks in chronic form of asthma.

20/11/1992

1966

Isometamidium Chloride

Indicated in treatment of cardiac arrhythmias including atrial fibrillation, ventricular tachycardia, arrhythmia.

1977-January

1967

Lamivudine (40mg) + Stavudine (10mg/5ml) reconstituted solution

For HIV infection.

08/04/2005

1968

Mesterolone

10mg

Oral androgen- In the treatment of potency disturbances, infertility and hypogonadism only.

1974-July

1969

Methicillin Sodium

Antibiotic- indicate in the treatment of infections due to pencillinase producing staphylococa.

1980-July

1970

Mometasone furoate

Mometasone furoate cream/ointment-0.1%

Topical corticosteroid- Steroid responsive dermatosis, eczema or atopic dermatitis.

1990- October

1971

Montelukast Orally Disintegrating Strips 4mg/5mg/10mg (additional Dosage form)

For the Relief of perennial allergic rhinitis in adults & pediatric patients 6 months of age and older.

29.05.15

1972

Nicardipine hcl capsules

Each capsule contains; nicardipine hcl-20mg,30mg

In treatment of hypertension and chronic stable angina pectoris.

27/10/1993

1973

Norethisterone enanthate injection

Injectable contraceptive- Indicated for contraception.

1986-April

1974

Norfloxacin tablets

Each tablet contains; norfloxacin-200mg,400mg,800mg, norfloxacin dispersible tablets-100mg(july 1993-alembic)

Antibacterial- Indicated in the treatment of acute uncomplicated/complicated chronic, recurrent urinary tract infections, including pyelonephritis, cystitis, urethritis & gonococcal infections.

1987-November

1975

Omnicide

Each litre have composition glutaraldehyde-15%, cocobenzyl dimethyl ammonium chloride-10%, dye<0.1%, perfume-6%, softwn water-0.5%

For the control of disease in animal premises.

24-08-1999

1976

Oxyphencyclamine Hcl.

10mg

Powerful anticholinergic agent.

1961- May

1977

Phenyramidol hydrochloride

200 mg tabs

Analgesic-muscle relaxant.

1962- August

1978

Pindolol

Each tablet contains; Pindolol-5mg

Î²-Blocker

1973-November

1979

Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial

Chronic congestive heart failure.

22/03/2006

1980

Prothionamide B.P.

Anti T.B.

1972-June

1981

Ramipril + Hydrochlorthiazide tabs

Each tab contains; ramipril-2.5mg,5mg, Hydrochlorthiazide-12.5mg,25mg

Mild to moderate hypertension in patient (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion.

26/08/1996

1982

Rofecoxib

Each uncoated tablet contains; rofecoxib-12.5mg,25mg

By RMP-for osteoarthritis, acute pain, dysmenorrhoea only.

26-06-2000

1983

Saxagliptin (as HCl) 2.5mg/ 5mg Tablets

Each film coated tablet contains; saxagliptin hydrochloride eq.to saxagliptin-2.5mg, 5mg

As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings).

26.10.09

1984

Serratio peptidase tablets

Each tablets contains; serratio peptidase-5mg

Oral enzyme- Indicated for the remission of various inflammatory disorders including post-operative inflammation and traumatic injury.

1985-September

1985

Silodosin Tablets 4mg

For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only.

10.04.12

1986

Solution for haemofiltration and haemodialysis

Each unit contains two compartments A & B. Before reconstitution; 1000ml of electrolyte solution in compartment A contains; calcium chloride.2H2O-5.145gm, magnesium chloride.2H2O-2.033gm, lactic acid-5.4gm, 1000ml of buffer solution in compartment B contaÞ¡

For treatment of acute kidney disease (renal failure), as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis.

05.01.11

1987

Somatropin injection (rDNA)

Each vial contains; 4 IU,16 IU, somatropin (rDNA), Each cartridge contains; 18 IU,36 IU, or 72 IU somatropin (rDNA)

Longterm treatment of children who have growth failure failure due to inadequate secretion of normal endogenous growth hormone and for treatment of short stature in children with Turner's syndrome confirmed by chromosomal analysis.

04/02/1998

1988

Stanozolol

Anabolic

1965- June

1989

Tetranicotinoyl fructose

Each tablet contains; tetranicotinoyl fructose-250 mg

1971- December

1990

Trolamine 0.67% (w/w) topical emulsion

0.67% w/w

For change in warning; to be sold by dermatologist only.

25/03/2004

1991

Zidovudine capsules & inj.

AIDS- Indicated in the treatment of short term management of serious manifestations of humam immuneno deficiency virus (HIV) infection in patients with AIDS.

1988-April

1992

Ampicillin + Probenecid

Each single dose vial contains; ampicillin-3.5gm, probenecid-1.0g

1983-February

1993

Bezafibrate tablets

Each tablet contains; bezafibrate-200mg

Lipid lowering agent- Indicated in all forms of hyperlipoproteinaemia.

1988-January

1994

Bisoprolol fumerate tab.

Each film coated tablet contains; bisoprolol fumerate (2:1)- 5mg,10mg

Anti hypertensive- Hypertension, coronary heart disease (angina pectoris).

27/02/1992

1995

Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml

(a). As a prophylaxis therapy for premature infants <29 weeks of gestational age at significant risk for Respiratory Distress Syndrome (RDS). (b). For the treatment of infants <72 hours of age with RDS (confirmed by clinical and radiologic findings) and rÞ¡

17.02.11

1996

Carbenoxolone sodium

Each tablet contains; Carbenoxolone sodium-50mg

1974

1997

Cefaclor cap./bulk

Each capsule contains; cefaclor-250mg,500mg (as cefaclor monohydrate), Each 5ml suspension contains; 125mg(as cefaclor monohydrate), 250mg92-7-910, Cefaclor drops-Each ml contains; cefaclor-100mg(as cefaclor monohydrate), Cefaclor suspension for paediatriÞ¡

Antibiotic- In respiratory infections, ENT infection, UT infections, Skin and skin structure infections.

1991- April

1998

Cefexime capsules

Each cap/tab contains; cefixime-100mg, 200mg(Torrent), 400mg(18-8-93, cadila)

Oral cephalosporin- in the treatment of UTI, respiratory tract infections, billiary tract infections.

24/02/1993

1999

Chandonium iodide injection

Each 2ml ampoule contains; chandonium iodide-2mg/ml

Marketed as neuromuscular blocking agent

01/03/1994

2000

Clonidine Bulk

Antihypertensive

1981-March

2001

Clotrimazole soft gel pessary

Each soft gelatin pessary contains; clotrimazole IP-100mg

Vaginal candidiasis.

17/02/1998

2002

Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.)

For BPH.

19/01/2006

2003

Danazol capsules

Danazol-100mg,200mg

Gonadotropic inhibitor- Indicated in the treatment of endometriosis, gynaecomastia, fibrocystic mastitis, prococious puberty and pubertal breast hypertrophy.

1982-March

2004

Dexlansoprazole delayed release capsule 30mg/60mg & Bulk

Each capsule contains; Dexlansoprazole 30mg (as modified release pellets), Each capsule contains; Dexlansoprazole 60mg (as modified release pellets)

For the treatment of i) Healing of all grades of erosive esophagitis (EE). Ii) Maintaining healing of EE and relief of heartburn. Iii) Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).

16.01.17

2005

Diazepam

Tranquiliser

1966- March

2006

Eribulin mesylate solution for injection 0.88mg / 2ml vial

Each 2ml vial contains; Eribulin (as mesylate) 0.88mg, Ethanol anhydrous 4.5% to 5.5%

For the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were Þ¡

27.01.12

2007

Fenfluramine hcl.

Each tablet contains; fenfluramine hcl-20 mg

Anti-obesity drug.

1972- April

2008

Fexofenadine suspension (30mg/5ml)

Seasonal allergic rhinitis & chronic idiopathic urticaria.

19.01.07

2009

Flupenthixol Hydrochloride

Each tablet contains; Flupenthixol Hydrochloride-0.5mg

1977-February

2010

Fluprednylidene acetate + Gentamicin

Fluprednylidene acetate-0.1%, Getamicin as sulphate-0.1%

1980-February

2011

Flurazepam capsules

Each capsule contains; flurazepam as hcl-15mg,30mg.

Hypnotic-indicated in all types of insomnia.

1985-August

2012

Fomepizole Bulk &1.5gm/Ampoule

Each ampoule contains; fomepizole hydrate 1.83ml eq.to fomepizole-1.5gm

As an antidote for Ethylene glycol or Methanol used poisoning or for use in suspected Ethylene glycol or Methanol ingestion, either alone or in combination with hemodialysis.

14.03.16

2013

Genatamicin sulphate

Each mL contains; Gentamicin sulphate eq to 2mg of Gentamicin base

1978

2014

Glybenclamide

Oral anti-diabetic

1970- April

2015

Haloperidol decanoate i.m injection

Haloperidol decanoate injection-50mg/ml,100mg/ml

In the management of chronic schizophrenia only

1990- February

2016

Hamycin glycerin

300000 units/ml

1971- January

2017

Hydroxychloroquine 400mg tablets (Additional Strength)

Same as Approved

31.01.08

2018

Isopropamide phenylpropanolamine Hcl.

Symptomatic relief of common cold, vasoconstrictor and antisecretary agent.

1967- February

2019

Lamotrigine

Each tab contains; Lamotrigine-50mg,100mg

21-01-2000

2020

Levocetirizine Syrup (2.5mg/5ml)

For allergic rhinitis & urticaria

13-01-2005

2021

Lixisenatide pre-filled solution for injection 10mcg/20mcg

Each dose (0.2ml) contains; 10mcg lixisenatide (3ml cartridge in a green pre-filled pen, 0.05mg/ml), Each dose (0.2ml) contains; 20mcg lixisenatide (3ml cartridge in a burgundy pre-filled pen, 0.1mg/ml)

For the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in patients who are not controlled on existing therapy: In combination with the following oral antibiotics Metformin, a sulphonyl urea, or a combination of these agentsÞ¡

15.01.15

2022

Lopinavir + Ritonavir

16/01/2004

2023

Meloxicam

Each uncoated tablet contains; 7.5mg,15mg

For the treatment of rheumatoid arthritis and soteoarthritis.

16/02/1999

2024

Fluphenazine enanthate

25 mg (1 c.c)

Tranquilizer

1967- December

2025

Meropenem powder for i.v inj.

Each vial contains; meropenem trihydrate eq.to anhydrous meropenem-500mg, 1000mg

For treatment of pneumonia, nonocomial pneumonia, UTI, intra-abdominal infection, gynaecological infection, skin & soft tissue infection, meningitis, septicaemia & empiric treatment of presumed infection in adult patients with febrile neutropenia.

08/01/2002

2026

Methandienone

Tabs 1mg & 5 mg

Anabolic agent.

1963- February

2027

Metronidazole Benzoate

Each 5mL suspension contains; Metronidazole Benzoate eq to 125mg of Metronidazole

1976-April

2028

Micafungin (as sodium) Powder for solution for infusion 50mg/vial

Each vial contains; micafungin sodium eq.to micafungin-50mg

For the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT)

04.02.09

2029

Naproxen

Naproxen-250mg

Steroidal anti-inflammatory agent indicated in the treatment of rheumatoid arthritis

1979-January

2030

Nealbarbitone

60-200 mg 3 times daily

Barbiturates with more sedative, less hypmotic effect.

1962- February

2031

Nicorandil tablets/bulk

Each uncoated tab contains; nicorandil-5mg,10mg,20mg, (For injection i.v 2mg,12mg,48mg-TPL 26-3-99)

For the prevention and long term treatment of angina pectoris.

10/01/1997

2032

Nitroglycerine

Each sustained release tablet contains; nitroglycerine-2.6mg

1975-March

2033

Nitroscanate tablets

Each tablet contains; nitroscanate-100mg,500mg

For control/eradication of hook worms/round worms/tape worms in puppies and adult dogs.

19/02/1996

2034

Pegaspargase Injection 3,750 IU/5 mL

Each 5.0ml vial contains; pegaspargase (pegylated L-asparaginase)-3750 IU

Indicated as a component of multi agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to asparaginase.

07.03.14

2035

Pericyazine

Severe anxiety, tension, schizophrenia, manic depression.

1968- February

2036

Ponderax sustained release tablets

Each sustained release tablet contains; fenfluramine hydrochloride-60mg

1984-September

2037

Protriptyline Hcl.

5mg & 10 mg

Anti-depressant.

1969- Februaryy

2038

Ranitidine injection

Each 2ml contains; ranitidine hydrochloride eq.to 50mg of ranitidine.

1986-February

2039

Repreterol tablets/syrups

Each tablet contains; repreterol-20mg, Each 5ml contains; repreterol-10mg.

1987-January

2040

Salinomycin bulk

1989-January

2041

Saroglitazar 2mg/4mg Tablets

Each uncoated tablet contains; saroglitazar 2mg, 4mg.

For the treatment of diabetic dyslipidemia and hypertriglyceridemia with type-2 diabetes mellitus not controlled by statin therapy.

25.02.13

2042

Sarpogrelate Hydrochloride film coated Tablets 100mg

Each film coated tablet contains; sarpogrelate hydrochloride-100mg

For the improvement of ischemic symptoms including ulcer, associated with chronic arterial occlusion.

19.01.10

2043

Terazosin hcl tablet

Each tablet contains; terazosin hcl eq.to 1mg,2mg,5mg of terazosin.

In the treatment of essential hypertension and BPH.

27/01/1995

2044

Theonar

1965- January

2045

Tramadol hcl + paracetamol tab

Each film coated tab contains; tramadol hcl-37.5mg, paracetamol-325mg

For short term(five days or less) management of acute pain in adults.

09/01/2003

2046

Triflusal

Each capsule contains; triflusal-300mg

By RMP- for treatment & prevention of vascular thromboembolism.

17-01-2001

2047

Vasolastine

2ml every other day

Enzyme complexes exerts a normalising influence on the deamination of amino acids and on lipid metabolism.

1961 January

2048

Xantinol nicotinate

Each sustained release tablet contains; Xantinol nicotinate - 500mg

1973-February

2049

Adrenochrome monosemicarbazone

1969- March

2050

Anti-rabies vaccine (Killed virus)

Vaccine against rabies.

1989-March

2051

Apixaban Tablets 2.5/5mg (additional Indication)

Treatment of deep vein thrombosis (DVT) and pulmonary Embolism (PE), and prevention of Recurrent DVT and PE in adult patients.

29.05.15

2052

Betahistine dihydrochloride

Indicated in the treatment as Meniere's syndrome characterised by unilatered or bilatered tinnitus, vertigo usually accompanied by sensory neural hearing loss.

1975- April

2053

Bromelin + Pancratin + Ox bile

Enzyme

Indicated for Pancreatic insufficiency.

1977-May

2054

Butafosfane + Cyanocobalamin injection

Each 100ml solution contains; butafosfane-10gm, cyanocobalamine-0.005gm

04/03/1998

2055

Cefpodoxime proxetil tab/syrup

i)-Each tab contains; cefpodoxime proxetil-100mg, ii)-Each 5ml suspension contains; cefpodoxime proxetil-40mg

Acute bronchitis, exacerbations of chronic bronchitis, bronchiolitis pneumonia, sinusitis, recurrent chronic tonsillitis, pharyngitis, acute otitis.

19-09-1997 to 19-09-1999

2056

Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur. (2.) Syrup...0.1 mg / ml Ph. Eur. (3.) Injection...1 mg / 2mlPh. Eur.

i) Each uncoated tablet contains; clebopride malate ph. Eur. Eq.to clebopride base-0.5mg, ii) Each ml syrup contains; clebopride malate ph. Eur. Eq.to clebopride base-0.1mg, iii) Each 2ml injection contains; clebopride malate ph. Eur. Eq.to clebopride basÞ¡

For the treatment of various disorders associated with altered gastrointestinal motility like non-ulcer dyspepsia (NUD) and / or chronic gastritis, gastroesophageal reflux disease (GERD), nausea and vomiting of organic or functional origin.

04.11.10

2057

Clidinium Bromide + Diazepam + Analgin

Each tablet contains; Clidinium Bromide-2.5mg, Diazepam-2.5mg, Analginv-500mg

1979-September

2058

Diclofenac colestyramine capsules

Each hard gelatin capsule contains; 145.6mg diclofenac-colestyramine (=diclofenac resinate) corresponding to 75mg diclofenac sodium.

For the treatment of acute arthritis (including attacks of gout), chronic arthritis especially rheumatoid arthritis (chronic polyarthritis), ankylosing spondylitis (morbus bechterew) and other inflammatory, rheumatoid syndromes of vertrebral column.

19.05.11

2059

Doxapram Hcl

Each vial contains; Doxapram Hcl-20mg

1978-November

2060

D-Pencillamine

300mg (1 to 4 tablets for daily)

Metalic poisoning- In the treatment of metalic poisoning and Wilson's disease.

1974-July

2061

Estraderm TTS 25/50/100 (finished formulation)

Estraderm transdermal TTS having estraderm-2mg,4mg,8mg estradiol.

23/02/1994

2062

Ethamivan

1965- June

2063

Fluphenazene

0.5mg

Anxiety & Tension only.

1961- May

2064

Formoterol fumerate + budesonide rotacaps.

Each cap.contains; formoterol fumerate-6mcg, budesonide-400mcg

Additional strength

07/03/2002

2065

Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength)

Same as Approved.

24.01.08

2066

Interferon alpha 2b injection.

Anti cancer- Indicated in the treatment of multiple myeloma hairy cell leukaemia etc.

1988-May

2067

Iopamidol sterile solution

X-ray contrast medium- Indicated in neuroradiology, angiography, urography, arthrography etc.

1986-june

2068

Ipratropium bromide respirator solution/nasal spray

Ipratropium bromide respirator solution-250mcg/ml, ipratropium bromide nasal spray each actuation delivers-20mcg.

08/04/1993

2069

Irbesartan

Each uncoated tablet contains; irbesartan-75mg,150mg,300mg

By RMP- for the treatment of mild to moderate hypertension only.

26-06-2000

2070

Lisinopril + Hydrochlorthiazid

Each uncoated tab contains; lisinopril-10mg,20mg,5mg, Hydrochlothiazide-12.5mg,25mg,12.5mg

23/11/1995

2071

Lomustine

Each capsule contains; 10mg, 40mg & 100mg of Lomustine

Anticancer

1980-August

2072

Loratidine + Pseudoephedrine tab

Each tab contains; loratidine-5mg, pseudoephedrine-120mg(ER)

For the relief of symptoms of seasonal allergic rhinitis.

21/08/1996

2073

Malathion 1% DustiPowder

for Pedicular

1973-December

2074

Micronised Purified Flavonoid 1000mg (MPFF)

Each film coated tablet contains; Diosmin 90% and Hesperidine 10% of Micronised Purified Flavonoid fraction 1000mg (MPFF)

Acute hemorrhoid piles

28.11.2013

2075

Mometasone furoate aqueous nasal spray

Each spray delivers mometasone furoate monohydrate eq.to mometasone furoate-50mcg

By RMP- for treatment of symptoms of seasonal or perrenial rhinitis in adults only.

18-05-2001

2076

Montelukast sodium chewable tablet 4mg/5mg and Montelukast sodium film coated tablet 10mg.

As add on therapy in mild to moderate asthma inadequately controlled by inhaled corticosteroids and short active B2 agonist, Exercise induced bronchoconstriction.

26.02.02

2077

Moxonidine tablet 0.2mg/0.3mg/0.4mg

For hypertension.

27.02.07

2078

Nilutamide tablets

Indicated in the treatment of metastatic or localised cancer of the prostate.

1991-October

2079

Oxymetazoline

Decongestant solution for nose & eyes.

1967- November

2080

Ozothine tablets/syrup

Tablets-60mg, syrup-60mg/5ml

Bronchodilator- Indicated in the treatment of acute & chronic infections of respiratory tract.

1987-December

2081

Paracetamol Bilayer Tablet 1000mg

For symptomatic treatment of pain and fever.

11.04.12

2082

Paramethasone acetate

Corticosteroid

1962- August

2083

Prazocin GITs tablets

2.5mg

In additional indication of B.P.H

14-09-1999

2084

Prednisolone

Each retard tablet contains; prednisolone IP-10 mg

1971- December

2085

Rabeprazole sodium injection

Each vial contains; lyophillized powder of rabeprazole sodium-10mg,20mg for i.v injection

By RMP- for the treatment of gastritic & deodenal ulcer, gastroesophagal reflux disease (GERD) as an alter native to oral therapy in patients who are unable to take oral proton pump inhibitor.

19/05/2004

2086

Ribavirin

Each capsule contains; ribavirin-100mg,200mg, Each 5/ml syrup contains; ribavirin-50mg

Anti viral agent- Acute hepatitis, viral respiratory and herpes infection.

1990- November

2087

Sarcolysin I.P.

Anti cancer

1972-June

2088

S(-) Metoprolol Succinate S.R. Tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg)

Each extended release tablet contains; s(-) metoprolol succinate eq.to s(-) metoprolol tartrate-12.5mg, 25mg, 50mg

For the treatment of essential hypertension in adults.

15/04/2005

2089

Sofradex-F cream

Sofradex-F cream contains; framycetin sulphate-1%, dexamethasone-0.1%, clotrimazole-1%

In the treatment of dermatologic disorders caused or complicated by infection by bacteria and/or fungi along with inflammation.

28/10/1993

2090

Tiotropium bromide rotacaps

Each cap contains; tiotropium bromide-18mcg

For maintenance treatment of COPD

16-04-2003

2091

Tobramycin Inhalation solution (300mg/5ml)

For chronic pulmonary infection cystic fibrosis.

22/03/2006

2092

Valganciclovir Powder for Oral Solution 50mg/ml

For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk.

09.10.09

2093

3-Phenylazo-2,6-diaminopyridine

1969- May

2094

Amifostine sterile lyophillized powder for inj.

Additional strength of 375 mg/vial on reconstitution each ml contain 50mg amifostine.

For import of finished formulation

03/05/2001

2095

Amiloride + Hydrochlorothiazide

Amiloride-5mg, Hydrochlorothiazide-50mg

Diuretic antihypertensive- Marketed in combination with hydrochlorothiazide indicated in the treatment of oedema and hypertension.

1979-September

2096

Artesunate injection. (Additional strength)

Each combipack contains: Artesunate for injection 120mg ( Each vial contains Artesunate IP 120mg), Sodium bicarbonate injection IP 5%w/v (Each 2ml ampoule contains: Sodium Bicarbonate IP 5% w/v), Sodium chloride Injection IP 0.9% w/v (Each 10ml ampoule coÞ¡

Promoted for use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only.

13.11.13

2097

Banoxinate hcl.

Indicated for use as an anaesthesia of cornea and conjuctivit for ophthalmic procedure.

24/11/1992

2098

Boplant

1965- June

2099

Buprenorphine sublingual tablets

Each tablet contains; buprenorphine hcl-eq.to 0.2mg of buprenorphine.

1987-December

2100

Calcitriol injection (finished formulation)

Each ml contains; calcitriol-1mcg,2mcg

19/03/1994

2101

Calcitriol oint.

Each gm contains; calcitriol-0.003mg (3mcg)

For treatment of mild to moderately severe plaque psoriasis (psoriasis vulgaris)

14-05-2003

2102

Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection.

For the treatment of infection caused by sensitive organisms viz. lower RTI, complicated UTI, Septicemia, bacteremia.

24.01.08

2103

Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection (additional strength)

As approved.

01.03.07

2104

Clotrimazole

Antifungal & local anti trichomonial agent- Indicated against certain bacteria, protozoa and against certain organism which are sensitive to metronidazole.

1975-May

2105

Dapoxetine (as Hydrochloride) Tablets â?¦30mg/60mg

Each film coated tablet contains; dapoxetine hydrochloride eq.to dapoxetine-30mg, 60mg

For the treatment of premature ejaculationÂ (PE) in men 18 to 64 years of age.

15.11.10

2106

Dothiepin hydrochloride

Anti depressant- indicated in the treatment of psychotic depression, neurotic depression, anxiety, depression.

1977-May

2107

Dried ferrous Sulphate + Ascorbic acid + Sodium Bicarbonate + Talcum

Each capsule contains; Dried ferrous Sulphate eq. To 50mg as Elemental Iron, Ascorbic acid-3mg, Sodium Bicarbonate-84mg, Talcum-12mg

1973-December

2108

Econazole ophthalmic ointment

In the traetment of fungal infection of the eye.

1985-September

2109

Fish gut sutures

28/08/1996

2110

Flavoxate Hydrochloride

100mg

Antispasmodic- indications for relief of dysuria, urgency, Nocturia, supropubic pain, frequency, incontinence prostatitis, urethritis,urethrocystitis,uretheotrigentis, vesico urethral spasms.

1980-November

2111

Flunarizine hcl.

Each capsule contains; flunarizine-5mg,10mg(6-9-93), Each tablet contains; flunarizine-10mg

For migraine- As a maintenanace treatment for classical and common migraine (prphylaxis).

1990- November

2112

Fluocinolone acetonide

Corticosteroid

1962- August

2113

Glibenclamide + Metformin tabs

Each film coated tablet contains; glibenclamide-2.5mg, metformin-400mg

30/11/1995

2114

Hydroxyurea USP

500mg

Anti neuplastic agent.

1971- January

2115

Imidacloprid + Moxidectin spot on solution

For dogs; each pipette containing 0.4ml, 1.0ml, 2.5ml, 4ml of 10% imidacloprid and 2.5% moxidectin, For cats; each pipette containing 0.4ml, 0.8ml of 10% imidacloprid and 1.0% moxidectin

For the treatment and prevention of flea infestation, treatment of ear mite infestation, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats.

05.04.11

2116

Ketoprofen Plaster 30mg (7cm X 10cm)

For the relief of musculoskeletal pain and inflammation.

18.04.12

2117

Lactobacillus brevis CD2 Lozenges 100mg (corresponding to not less than 1 billion) of live, lyophilised, lactic acid bacteria, Lactobacillus brevis CD2. (Additional indication)

Prevention of radiotherapy and chemotherapy induced oral mucositis in cancer patients.

09.08.14

2118

Lactulose Enema (20%)

For constipation & hepatic encepthalopathy.

28/03/2006

2119

Lafutidine Tablets-5mg/10mg.Â

Each tablet contains; lafutidine-5mg, 10mg

For the treatment of: i) gastric ulcers, duodenal ulcers and stromal ulcers. ii)gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis.

16.11.09

2120

Lamotrigine tab

Deletion of box warning on label/carton stating "the drug is contraindicated in children below 16 years of age"

05/03/2002

2121

Letrozole tabs

Each film coated tab contains; letrozole-2.5mg

Second line treatment of advanced breast cancer in women.

12/03/1998

2122

Medroxy progesterone acetate

Gynaecological disorders- Indicated in the treatment of secondry amenorrhea and functional uterine bleeding of hormonal imbalance only.

1986-June

2123

Melagenina lotion

For leucoderma- Indicated in repigmenting treatment of skin in depigmented areas of patients suffering from vertigo.

1988-May

2124

Methylhydroxy propyl cellulose

Methylo hydroxy propyl cellolose-0.3%

By RMP- for temporary relief of discomfort due to minor irritation of the eye from exposure to wind sun or other irritants for use as a protectant against further irritation or to relief dryness of then eyes.

05/07/2000

2125

Norethindrone acetate

5mg

Twice as potent as the parent drug.

1961- June

2126

Omeprazole magnesium tablets/bulk

Each enteric coated tab contains; omeprazole magnesium eq.to omeprazole-10mg,20mg

17-09-1999

2127

Parvo virus vaccine (Killed)

Immunization of healthy dogs against canine parvovirus infections.

1989-March

2128

Penamecillin

0.35g

Anti-bacterial

1967- December

2129

Pimozide

Neuroleptic and anti psychotic agent- In the treatment of chronic Schizophrenia.

1974-August

2130

Pyrantel Pamoate USP

Anthelmitic

1972-July

2131

R(+) Ondansetron (2mg/4mg) tablet

Each tablet contains; R(+) ondansetron Hcl.2H2O eq.to R(+) ondansetron-2mg, 4mg

For the treatment of chemotherapy induced nausea and vomiting.

15/04/2005

2132

Ruxolitinib 10mg tablet (additional Strength)

1. For the treatment of patients with myelofibrosis including primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. 2.Treatment of patients with polycythemia vera who are resistant to or intolerant ofÞ¡

29.05.15

2133

Simvastatin tab

Each tab contains; simvastatin-5mg,10mg,20mg,40mg

Primary hypercholesterolemia, type Iia & Iib alone or in association with CAD

25-09-1997 to 25-09-1999

2134

Sodium Chloride IP + Sodium Acetate NF + Calcium Chloride USP + Magnesium Chloride BP + Potassium Chloride IP

(Mount mettur)-Each 100ml contains; Sodium Chloride IP-20.047gm, Sodium Acetate NF-19.047gm, Calcium Chloride USP-0.859gm, Magnesium Chloride BP-0.366gm, Potassium Chloride IP-0.522gm, (Elys Hjekt)- Sodium Chloride IP-20.475gm, Sodium Acetate NF-19.054gm,Þ¡

1978-November

2135

Sulphachloropyrazine sodium 30%

18/10/1993

2136

Trolamine topical emulsion

For additional specialists-oncologists

14/05/2004

2137

1-(2-tetrahydrofuryl)-5-Fluorouracil

Anticancer drug- indicated in the treatment of cancer of stomach, colon, rectum, breast and lung.

1977-June

2138

Ambroxol tablet/liquid/drops

i)-Each tab contains; ambroxol hcl-30mg, ii)-Each 5ml liquid contains; ambroxol hcl-30mg, iii)-Each ml drop contains; ambroxol hcl-7.5mg

Antitussive- acute and chronic disease of the respiratory tract associated with abnormal bronchial secretions in particular acute attacks of chronic bronchitis, asthmatic bronchitis, bronchial asthma.

01/12/1995

2139

Aminomix-2

Solution A-500ml, solution B-500ml

By-RMP- for complete parentral nutrition

04/07/2000

2140

Amsacrine injection

Anti cancer.

26/02/1992

2141

Artesunate inj.

Each ampoule contains; artesunate-60mg

Promoted for use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only.

02/09/1996

2142

Auranofin capsules

Each capsule contains; auranofin-3mg

Anti rheumatic- Indicated in the treatment of rheumatoid arthritis and in children with juvenile rheumatoid arthritis.

1987-December

2143

Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate

For use as an intra ocular irrigation solution during intraocular surgical procedures involving perfusion of the eyes.

29/04/2005

2144

Betamethasone Dipropionate

Each gm contains; 0.64 mg of Betamethasone dipropionate eq to 0.5mg of Betamethasone, (0.05%).

Topical corticosteroid- Indicated in the treatment of psoriosis, contact dermatitis, atopic dermatitis neurodermatitis, senile pruritus.

1979-October

2145

Bicalutamide tabs/bulk

Each film coated tab contains bicalutamide-50mg

Advanced prostatic cancer in combination with LHRH analogue on surgical castration.

07/03/2002

2146

Cephalothin Sodium, Cefalotin sodium

Cephalosporin antibiotic- in the treatment of infections of soft tissue, respiratory and urinary tract, meningitis other infections due to susceptible organisms and in the treatment of infections due to penicillin resistant strains of straphylococci.

1980-December

2147

Cyclosporin oral solution, concentrate for inj. & capsules

Immuno suppressant- Indicated in immuno-suppression in organ transplants.

1988-June

2148

Diazinon flea drops spot on dogs 30.0 % w/w

Each ampoule pipette contains; diazinon-30.0% w/w

For dogs infected with fleas.

11.11.11

2149

Diclofenac sodium suppositories

Each suppository contains; diclofenac sodium-100mg (adults), 12.5mg (children)

26/09/1997

2150

Doxorubicin hcl pegylated liposomal inj.

Each vial (fill volume of 25ml) contains 50mg doxorubicin hcl

Import of finished formulation in additional strength.

03/05/2001

2151

Doxycycline

100mg and 10mg/ml

Broad spectrum antibiotic.

1967- December

2152

Fexofenadine + pseudo ephedrine ER Tabs

Each film coated tab contains; fexofenadine-120mg, pseudo ephedrine sulphide USP in ER form-180mg

Allergic & seasonal rhinitis only

17-09-1999

2153

Flunisolide nasal spray

Flunisolide-0.025% w/v

For the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever.

30/11/1993

2154

Fluocortolone + Fluocortolone Caproate + Neomycin Sulphate

Each gm contains; Fluocortolone-2.5gm, Fluocortolone Caproate-2.5mg, Neomycin Sulphate-5mg

1978-November

2155

Haloperidol Tablet (0.5mg) (addl. Lower strength)

As approved earlier.

30/03/2006

2156

Hydroxycobalamine

Same as vitamin B12 quicker, higher & prolonged blood .

1961- July

2157

Ibuprofen

200mg

Anti rheumatic.

1971- March

2158

Lacti syn conc. Amps

1965- June

2159

Lorazepam

Each tablet contains; Lorazepam-1mg, 2mg

Psychiatric drug

1973-December

2160

Lorazepam Orodispersible Tablet 1mg/2mg (additional Dosage form)

For the management of anxiety disorders or for the short term relief of symptoms of anxiety or anxiety associated with depressive symptoms.

29.05.15

2161

Marek's disease vaccine

1972-July

2162

Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet

For the treatment of Type-II diabetes associated with mixed dyslipidemia.

25.01.08

2163

Nicotinamide hydrochloride

B complex

1962- September

2164

Opipramol dihydrochloride Tablet 50mg/100mg.

Each film coated tablet contains; opipramol dihydrochloride-50mg, 100mg

For the Treatment of generalised anxiety disorder (GAD) and somatic disturbances.

15.11.10

2165

Oxazepam

Each tablet contains; 30mg oxazepam

1969- May

2166

Oxolinic acid

Urinary antibacterial- For the treatment of acute & chronic urinary tract infections.

1974-September

2167

Pegylated liposomal doxorubicin hcl inj.

Additional indication- metastatic breast cancer in patients where there is an increased cardial risk.

14-05-2003

2168

Propranolol hcl sustained release tablets

Each tablet contains; propranolol hcl eq.to 80mg,160mg

1985-September

2169

Quetiapine (As fumarate) SR 400mg tablet (additional strength)

As approved.

05.03.07

2170

Racecadotril sachet

10mg, 30mg

By RMP

19/05/2004

2171

Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg/2mlÂ

1) Each tablet contains; ramosetron hydrochloride-2.5mcg, 5mcg, 0.1mg. 2) Each 2ml injection contains; ramosetron hydrochloride-0.3mg

1) Tablets 0.1mg & Injection 0.3mg/2ml-for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer chemotherapy. 2) Tablets 2.5mcg & 5mcg-for the treatment of adult patients with diarrhoea predominÞ¡

12.11.09

2172

Rivaroxaban tablet 15/20mg (Additional strength/indication)

1. Treatment of deep vein thrombosis and for prevention of recurrent DVT and pulmonary embolism. 2. For the prevention of stroke and systemic embolism in patient with non-valvular arterial fibrillation.

02.09.14

2173

Salazopyrin

Each enteric coated tablet contains; salazopyrin-500mg

For rheumatoid.

1990- November

2174

Sodium hyaluronate solution

10mg/ml

* Intra ocular surgery.

1989-June

2175

Sodium of Methylglucomine + 3,5-diacetamido-2,4,6-triodobenzoic acid

X-ray contrast media.

1975-May

2176

Sterile Solution for Peritoneal Dialysis

Each 1000 ml contains: Calcium chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + LAlanine 0.951 g/l + L- Arginine 1.071 g/l + L- Isoleucine 0.85 g/l + L- Histidine 0.714 g/l + L- Leucine 1.02 g/l + L- Lysine (as Hcl) 0.955 g/l + L-Methionine 0.85 g/l + LPÞ¡

As Nutritional supplements for malnourished renal failure patients (Albumin concentration lower than 35 g/litre) being maintained on peritoneal dialysis.

18.04.12

2177

Tapentadol Extended release Tablet 50mg (Additional Strength)

For use in in-patients for dose titration under hospital settings for severe acute pain for a period not exceeding 5 days.

12.11.13

2178

Toltrazuril solution

Each 100ml solution contains; toltrazuril-2.5gm

30/04/1998

2179

Vancomycin hcl injection (finished formulation)

i)-Each vial contains; vancomycin hcl eq.to vancomycin-500mg,1000mg ii)-Each cap contains; vancomycin hcl eq.to vancomycin-125mg,250mg

28/03/1994

2180

Vecuronium bromide injection

Muscle relaxant, neuromuscular blocking agent- Indicated for use in anaesthestic to relax muscle during surgical procedures and to facilitate contraction ventilation.

1986-june

2181

Albendazole

Albendazole-2.5% w/v, 10% w/v

Anthelmetic- indicated in the control of Gastro-intestinal roundworm, lungworm, tapewarm & adult liver flukes in cattle, sheep.

1979-October

2182

Apraclonidine ophthalmic solution

Each ml contains apraclonidine hcl USP-0.575%w/v,1.15%w/v eq.to apraclonidine-0.5%w/v, 1%w/v

% solution is indicated in control of intra ocular pressure following anterior segment laser surgery, 0.5% solution is indicated for short term adjuncture treatment of chronic glaucoma.

15-03-2002

2183

Beclomethasone Dipropionate B.P.

Topical corticosteroid.

1973-February

2184

Brimonidine topical gel 0.33% (Add. Dosage form/indication)

For the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.

18.06.15

2185

Cabergoline 1mg tablet (additional strength)

For Hyperprolactinemia.

06.03.07

2186

Cefpirome injection

Each vial contains; cefpirome sulfate corresponding to cefpirome-0.25g, 0.5g, 1.0g, 2g

Infections caused by cefpirome sensitive organisms, lower respiratory tract infection, complicated upper and lower urinary tract infections bacteraemia/septicaemia.

26-09-1997 to 26-09-1999

2187

Chenodeoxycholic acid capsules

Each capsule contains; chenodeoxycholic acid-250mg

Dissolution of all bladder stone.

1987-December

2188

Cholestyramine Powder for oral suspension (4gm/sachet)

For hypercholesterolaemia.

30/03/2006

2189

Ciclopirox olamine solution/cream/vagina cream

Solution-Each ml contains; 10mg of ciclopirox olamine, Cream-1gm contains; 10mg as ciclopirox olamine, Vaginal cream-1gm contains;10mg of ciclopirox olamine

Anti fungal- Indicated in the treatment of fungal infections of the skin and vagina.

1985-October

2190

Collagen with gentamicin implant

Control of infection in surgical procedures, bone marrow, osteomyelitis, osteitis loosened prosthesis, osteosynthesis, spondylodiseitis, facial bone defect, soft tissue rectal amputation vascular graft surgery, colostomy surgery.

06/05/1998

2191

Desamino-oxytocin

Indicated in the treatment of induction of labour for various reasons for adequate uterine action.

1974- December

2192

Desoximetasone

Topical corticosteroid- Indicated in the management of various acute and chronic dermatoses viz eczema, nummular eczema, infantile eczema, atopical dermatitis.

1975-July

2193

Dihydrotestesterone gel (finished formulation)

25/04/1994

2194

Divalproex Sodium Oral Solution 500mg/5ml (Additional Dosage Form)

For monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with types of seizures for adult patients only.

23.12.13

2195

Doxapram Hcl

Respiratory stimulant- for the treatmnet of post-operative respiratory depression and respiratory depression due to poisoning.

1977-September

2196

Doxepin Hydrochloride

Psychotic drug

1972-July

2197

Fitostimoline topical cream & vaginal pessary

1) Each 100gm of cream contains; Aqueous extract of Triticum Vulgare (dry residue 200mg/100ml)-15gm, 2-phenoxyethanol Eur. Ph-1gm.Â 2) Each 3.5gm of vaginal pessary contains; Aqueous extract of Triticum Vulgare (dry residue 200mg/100ml)-0.60gm, 2-phenoxyÞ¡

Cream- for the treatment of ulcers and bed sores. Vaginal pessary- for the treatment of phlogistic and dystrophic disorders of the female genital tract.

20.11.09

2198

Fluorometholone + Neomycin sulphate sterile ophthalmic suspension

Each ml contains; fluorometholone-1mg, neomycin sulphate-3.5mg (as base), benzalkonium chloride-0.04mg

In the treatment of infected inflammatory ocular conditions.

04/09/1996

2199

Gliclazide M.R. (30mg/60mg) + Metformin HCl (500mg) ER Tablet

For type-II diabetes.

27/04/2005

2200

Haloperidol

Each tablet contains; 0.25mg of haloperidol

1969- May

2201

Heparinoid & Hyaluronidase

3-5 cm of ointment applied 2-3 times a day

Thrombophlebitis, tendovaginitis, sprains etc.

1967- December

2202

Hydroxychloroquine Sulphate Tablet 300mg (Additional strength/indication)

Indicated for the treatment of patietns with lower body weight i.e 45 to 60kg in Rhemuatoid arthritis, Systemic Lupus Erythematosus & Polymorphic Light Eruption.

09.08.14

2203

Levosalbutamol (as sulphate) inhalation solution

Each 2.5ml contains; levosalbutamol (as sulphate) 0.63mg/1.25mg

By RMP- for treatment or prevention of bronchospasm in adults and adolescents with reversible obstructive airway disease.

04/06/2001

2204

Loratidine + pseudoephedrine suphate in ER form

Each film coated tab contains; pseudo ephedrine sulphate (ER)-180mg, loratidine-10mg

Allergic & seasonal rhinitis only

17-09-1999

2205

Mebendazole

Each 5mL contains; Mebendazole-100mg

1978-December

2206

Mebeverine hcl

50mg (1-2 tablets 3-4 times daily)

Musculo tropic spasmolytic

1971- March

2207

Mebrophen hydramine

Anti-histamine

1965- June

2208

Nitroglycerin injection

Cardiac drug- Indicated in the treatment of angina pectoris, myocardial infarction etc.

1986-June

2209

Pefloxacin eye drops

Pefloxacin mesylate dihydrate eq.to pefloxacin-0.3% w/v

12/11/1993

2210

Protokylol hydrochloride

Solution: inhaler-1:100, Injection-0.5mg, Tablet-2mg

Bronchodilator

1961- July

2211

Pyrvinium pamoate

Anthelmintic

1962- October

2212

Rabies vaccine inactivated (Verocell)

Indicated for treatment after exposure to rabies and for pre-exposure prophylaxis.

1988-November

2213

Recombinant human erythropoietin rHuEPO

For additional indication; anemia associated with cancer to conditions of letter (even no.dated 27-1-1993)

12/07/2000

2214

Recombinant human tissue type plasminogen activation injection (Actilyse)

20mg, 50mg per vial

For fibrinolytic therapy in acute thrombotic coronary artery occlusion.

1989-July

2215

Revaprazan tablet

Each film coated tablet contains; revaprazan-100mg, 200mg

For the short term treatment of gastric ulcer, duodenal ulcer and for improvement of mucosal lesion in acute and chronic gastritis.

26.09.11

2216

Salicylic acid 10mg/20mg (Foaming facewash solution)

For the treatment of acne vulgaris.

28.01.08

2217

Sodium enoxaparin (LMWH)

Sodium enoxaparin injection low molecular weight heparin-20mg,40mg

As a prophylactic in the treatment of thromboembolic disorders during orthopaedic surgery, general surgery and haemodialysis.

13/03/1992

2218

Sodium Hyaluronate Injection 8mg/vial (6ml Pre-filled syringe for Intra Articular use only)

Indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesic.

23.04.12

2219

Tacrolimus oral capsules

Each capsule contains; tacrolimus 0.5mg,1mg,5mg

By nephrologists only- for the prophylaxis of organ rejection in patients receiving allogenic kidney transplant.

21/05/2004

2220

Temsirolimus Concentrate for Infusion for Injection 25mg/mlÂ

Each vial contains; temsirolimus-25mg/ml

For the treatment of advanced renal cell carcinoma

15.12.10

2221

Tramadol hcl ER tab

Each ER tab contains; tramadol hcl-300mg,400mg

Additional strength- management of moderate to severe pain.

20-05-2003

2222

Xylazine hcl

Each ml contains; xylazine-20mg

Used as a sedative analgesic and muscle relaxant properties for use in horses, dogs and cattle's.

1990- November

2223

Zinc and vitamin-C chewable tablet

Each chewable tablet contains; zinc gluconate 87.1mg (eq.to elemental zinc 12.5mg), ascorbic acid-100mg, sodium ascorbate-170mg (eq.to 150mg of ascorbic acid)

12/12/1995

2224

Atorvastatin calcium tablets

Each film coated tablet contains; atorvastatin calcium eq.to atorvastatin-10mg, 20mg, 40mg

As an adjunct diet to reduce elevated total cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia (type IIa & IIb)

17-09-1999

2225

Autolysate of B-subtilis and B-megatherium

Anti allergic- indicated in the treatment of bronchial asthma recurrent inflammation of the broncho-phyrinx, tonsils in children, rheumatic disease.

1975-July

2226

Bacampicillin tablets

Each tablet contains; bacampicillin hcl eq.to 400mg of bacampicillin

Antibiotic- Indicated in the treatment of upper & lower respiratory tract infections, urinary tract infections, skin infections, gonorrhea, sinusitis, tonsilitis, acute & chronic bronchitis, otitis media, post-operative infections.

1985-October

2227

Biperiden Hydrochloride

Parkinsonism

1972-July

2228

Colfosceril palmitate inj.

Each vial contains; colfosceril palmitate-108mg

New born babies with birth weight of 700gm or greater, undergoing mechanical ventilation of respiratory distress syndrome, whose heart rate and arterial oxygenation are continuously monitored.

01/12/1993

2229

Cypermethrin high cis

Each litre contains; cypermethrin high cis-100gm

For the control of tick, flies, lice and mites on cattle, sheep, dogs and poultry.

16/09/1996

2230

Desmopressin intranasal solution/nasal solution/nasal spray/injection

Central or neurogenic diabetes insipidus, bleeding disorders nocturnal enuresis.

1989-August

2231

Diclofenac Sodium Sustained Release Tablet (Two layered tablets) 150mg.(Additional Dosage Form)

Each tablet contains Diclofenac Sodium IP-125 mg Slow Release, Diclofenac Sodium IP-25 mg Immediate Release.

For symptomatic treatment of pain and inflammation in irritation in association with degenerative joint disease/osteoarthritis.

20.12.13

2232

Dog collar band containing deltamethrin 4% w/w

Each band contains; deltamethrin-4% w/w

For control of infestations with ticks for 6 months, anti-feeding effect on phlebotomine sand flies for 5 to 6 months, prevention of infestations by fleas for 4 months, anti-feeding effect on adult mosquitoes for 6 months.

25.08.11

2233

Doxofylline Syrup (20mg/ml)

For bronchial asthma & COPD.

30/03/2006

2234

Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet)

Oral Contraceptive.

11/05/2005

2235

Estramustine phosphate capsules

Anti cancer drug- Indicated in the treatment of prostatic carcinoma.

1986-july

2236

Febuxostat Tablets 80mg / 120mg

Each film coated tablet contains; febuxostat-80mg, 120mg

For treatment of chronic hyperuricemia in conditions where urate depression has already occured (including a history, or presence of tophus and /or gouty arthritis).

18.11.09

2237

Flupirtine Maleate Sustained Release Tablets 400mg

For the treatment of acute and chronic pain, i.e. for painful increased muscle tone of the posture and motor muscle, Primary Headache, tumor pain, Dysmenorrhea and pain after Traumatology/Orthopedic Operations and injuries.

18.10.12

2238

Fortison liquid/powder, Pepti-2000 liquid/powder

27/01/1995

2239

Gatifloxacin eye drops

Each ml contains; gatifloxacin-3mg

For treatment of external bacterial infection of eyes.

21-05-2003

2240

Gestodene + ethinyl estradiol

Each film coated tablet contains; gestodene-60mcg, Ethinyl Estradiol-15mcg, 24 tablets + 4 dummy tablets per pack

By RMP- oral contraceptive for women

17/07/2000

2241

Ginkgo biloba extract Tablet 120mg (Additional strength)

For the treatment of dementia, vertigo and tinnitus in adult patients.

09.12.14

2242

Idebenone tablets

Each sugar coated tab contains; idebenone-30mg

In the treatment or improvement of decreased volition, emotional disturbance and speech disturbances associated with sequelae of cerebral infarction, sequelae of cerebral haemorrhage, cerebral asteriosclerosis.

26-09-1997 to 26-09-1999

2243

Iobenzamic acid

Oral cholecystography

1965- August

2244

Latanoprost eye drops

Each ml of eye drop contains; latanoprost-50mcg

In the treatment of glaucoma and ocular hypertension.

12/05/1998

2245

Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.)

Antibiotic (For adult use only).

07.03.07

2246

Levonorgestrel + ethinyl estradiol

Levonorgestrel-0.25mg, ethinyl estradiol-0.05mg

For emergency contraception in women, only till such time the newer option like levonorgestrel (0.75mg) is available in market.

07/06/2001

2247

Linezolid tablets

Each tablet containg; linezolid-600mg

For additional indication- By RMP- osteomyelitis in adults.

30/05/2004

2248

Lymecycline

Antibiotic.

1962- October

2249

Mizolastine MR tabs.

Each MR film coated tab contains; mizolastine-10mg

Symptomatic relief of seasonal allergic rhino conjuctivitis (hay fever) perinnial allergic rhinoconjuctivitis and urticaria.

05/03/2002

2250

Natamycin

Each vaginal tablet contains; Natamycin-25mg

1979-October

2251

Octreotide injection (finished formulation)

30/06/1994

2252

Oral polio vaccine

Vaccine (polio) oral.

06/05/1992

2253

Ozagrel Hcl. Tablets 100mg/200mg

For the treatment of bronchial asthma.

28.01.08

2254

Panchronium bromide

4mg/ml (4 to 6 mg)

Muscular relaxanting agent.

1971- April

2255

Parbendazole (B vet C)

Treatment of Helmenthiasis

1973-February

2256

Pentoxyphylline SR

Each pentoxyphylline SR tablet contains; pentoxyphylline-400mg

Indicated for the same purpose as for plane conventional dosage.

1990-March

2257

Propranolol sustained release capsules

Each sustained release capsule contains; propranolol hcl-80mg

1987-December

2258

Purified chick embryo cell (PCEC) rabies vaccine (HEP flury virus strain)

Vaccine- Indicated for treatment after exposure to rabies and for pre-exposure prophylaxis.

1988-November

2259

Ramelteon film coated tablets 8mg

Each film coated tablet contains; ramelteon-8mg

For the treatment of insomnia characterized by difficulty with sleep onset.

21.12.10

2260

Rivaroxaban tablet 2.5mg (add. strength)

Rivaroxaban 2.5mg tablet, co-administered with Acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated Þ¡

13.07.15

2261

Sodium iron edetate

55 mg

Iron chelate-EDTA

1961- August

2262

Suramin Injection

1977-September

2263

Trichlormethiazide USNF

Each tablet contains; Trichlormethiazide USNF-2mg

Diuretic- in the treatment of hepatic cirrohsis, edema, hypertension.

1978-December

2264

Trithioparamethoxy phenyl propene

Each tablet contains; Trithioparamethoxy phenyl propene-12.5mg

1969- May

2265

Testosterone decanoate & isocaproate

100 & 250 mg of 1 ml

Androgenic

1964- January

2266

Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. To Chromuim 200mcg Capsule

For the treatment of diabetic neuropathy.

03.01.11

2267

Amphotericin B lipid complex inj.

Each 10ml, 20ml injection contains; amphotericin B (USP)-5mg/ml

By RMP- for the treatment of invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin-B therapy.

12/07/1996

2268

Bendamustine Hydrochloride lyophilised injection 25mg (Additional strength)

Treatment of patients with chronic lymphocytic leukemia.

19.09.14

2269

Benorylate

Tablet-Each tablet containing 250mg of Benorylate, Suspension-Each 5mL contain 2gm of Benorylate.

Analgesic & antipyretic- treatment of headache, bodyache, fever, rhinitis, sinutitis.

1978-December

2270

Betamethasone

0.5mg

A corticosteroid.

1961- August

2271

Feracrylum 3% gel

For the management of post-operative wounds cuts, Abrasions as a Haemostatic Agent cum anti-septic.

13.02.2002

2272

Betamethasone Sodium Phosphate + Gentamicin Sulphate

Each mL contains; Betamethasone Sodium Phosphate-1mg, Gentamicin Sulphate eq to 1mg of Gentamicin.

1977-November

2273

Bupivacaine Hydrochloride

Anaesthetic

1972-September

2274

Butenafine + betamethasone dipropionate cream

Each gm of cream contains; butenafine hcl-10mg, betamethasone dipropionate eq.to betamethasone-0.5mg

Superficial fungal infections, dermatophytes infections.

15/03/2002

2275

Captopril tablets

Each tablet contains; captopril-25mg,50mg

Anti hypertensive agent- Indicated in the treatment of hypertension only.

1985-October

2276

Carbadox

Antibiotic- indicated in the treatment of swine dysentry and bacterial enteritis.

1975-July

2277

Cefdinir dispersible tablets

125mg

For additional indication.

2004

2278

Ciprofloxacin + Dexomethasone eye drops

Each 5ml contains; ciprofloxacin-0.3% w/v, dexomethasone-0.1% w/v

For post operative steroid responsive inflammatory ocular conditions when bacterial ocular infections or a risk of bacterial ocular infections exists.

29-09-1999

2279

Clindamycin 1% + Isotretinoin 0.05% gel

For acne.

08.03.07

2280

Cyclopentolate hcl

Cyclopentolate hcl BP-0.5%,1%,2%

For mydriasis and cycloplegia.

1990-March

2281

Dilazep Dihydrochloride

56 mg of Dilazep Dihydrochloride eq to 50mg of Dilazep

Cardiac drug- indicated in the treatment of coronary insufficiency, coronary sclerosis, angina pectoris as well as for prophylaxis and follow up treatment of myocardial infarction.

1979-November

2282

Disodium pamidronate injection

Tumour inducer hypercalcaemia.

21/02/1995

2283

Doramectin 1% injectible solution

Each ml contains; doramectin-10mg

Treatment and control of gastrointestinal round worms, lung worms, eye worm, screw worms in cattle.

17/10/1997

2284

Ethacridine Lactate

Anti-diarrhoeal agent.

1973-February

2285

Etoposide capsule & injection

Each 5ml ampoule contains; etoposide-100mg, etoposide capsules-50mg(4-11-92)

Anti cancer- Indicated in the treatment of small cell lung cancer, malignant lymphomas, acute leukaemia, testicular tumours etc.

1988-March

2286

Flavophospholipol (Flavomycin)

Antibiotic- Used as feed additive in farm animals and poultry farm, birds.

1989-September

2287

Genotropin 4iu/12iu/16iu injection (finished formulation)

Short stature due to inadequate or failed incretion of pituitary growth hormone.

05/09/1994

2288

Hepatitis B vaccine (recombinant DNA)

For treatment of Hepatitis B virus infection.

1987-January

2289

Ivabradine HCL Tablets 5mg/7.5mg (Additional indication)

Additional indication of "treatment of chronic heart failure in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is > 75 bpm, in combination with standard therapy including beta-blocker Þ¡

19.12.13

2290

korsolex concentrated instrument disinfectant

20/05/1992

2291

Lacosamide Injection 10mg/ml

As an adjunctive treatment of partial onset seizures in patients>17 years of age.

19.10.12

2292

Lafutidine Tablets-5mg/10mg.Â

Each tablet contains; lafutidine-5mg, 10mg

19.01.10

2293

Lamotrigine ER Tablet 25mg/50mg/100mg/200mg

Add-on therapy for partial and secondary generalised tonic-clonic seizures.

06.08.12

2294

Maraviroc Tablets 150mg/300mg

Each film coated tablet contains; maraviroc-150mg, 300mg

For the treatment of patients infected with CCR5- trophic HIV-1.

26.11.09

2295

Meglumine Iothalamate

Angiography

1965- August

2296

Methylmercadone (Nifuratel)

200mg tabs & 250mg vaginal tabs.

Urinary tract infection by leucohhea and vulvo vaginitis.

1967- December

2297

Nimesulide

Each controlled release tab.contains; nimesulide-200mg

By RMP- for treatment of mild to moderate pain of O.A and R.A

07/06/2001

2298

Prednimustine tablets

Anti cancer drug- Indicated in the treatment of chronic lymphocytic leukaemia, non-hodgkin's lymphoma and breast cancer.

1986-July

2299

Promegestone tabs

Each tab contains; promegestone-0.125mg,0.250mg,0.500mg

Gynaecological conditions characterized by luteal insufficiency, menstrual irregularities due to ovulation disorders, dysmenorrhea, premenstrual syndrome, mastodynia, dysfunctional uterine bleeding menorrhagia due to fibromyomas, menopausal syndrome.

23/09/1996

2300

Resperidone Tablet & Syrup (addl. Ind )

Acute mania & mixed episode in bipolar-I disorder.

04/04/2006

2301

Rifampicin

450mg

Anti T.B drug

1971- June

2302

Cyclandelate

Vasodilating agent

1972-October

2303

Rosiglitazone + metformin (SR) tab

Rosiglitazone-2mg,4mg, metformin Sr-1000mg

RMP- For the treatment of patients with type-2 diabetes mellitus when diet exercise and the single agent do not result in adequate glycemic control.

20-05-2003

2304

Salmeterol inhaler/rotacap

Each actuation delivers; salmeterol xinafoate-25mcg, Each rota caps contains; salmeterol xinafoate eq.to salmeterol-50mcg

Long term regular treatment of reversible airway obstruction in asthma, and chronic bronchitis.

01/12/1993

2305

Simvastatin (10/20mg) + Ezetimibe (10mg) Tab

Each film coated tablet contains; simvastatin USP-10mg, 20mg, Ezetimib-10mg

For the treatment of patients with primary Hypercholesterolemia.

11/05/2005

2306

Trithiopara methoxy phenyl propene

Oral formulation

1962- October

2307

Trithioparamethoxy phenyl propene + chlopheniramine maleate

Each tablet contains; Trithioparamethoxy phenyl propene-12.5mg, chlopheniramine maleate-3.0mg

1969- May

2308

Vericella vaccine

Each dose (0.5ml) of the reconstituted vaccine contains not less than 103.3 plaque forming units of the attenuated varicella zoster virus.

For active immunization agaist varicella of healthy subjects from the age of 12 months onwards.

19/06/1998

2309

1-Nicotinylamine-1,2-diphenylethane

1969- June

2310

Acipimox Capsules 250mg.

Each capsule contains; acipimox-250mg

As adjunctive therapy to diet in the treatment of hyperlipidaemias of type IIa, IIb and IV.

01.12.09

2311

Chemically modified sodium hyaluronate and carboxymethylcellulose absorbable adhesion barrier

It is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose membrane (CMC)

As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of posoperative adhesions at the site of placement.

12.02.10

2312

Cobalt glutamate copper succinate

30mg=5mg Co, 2mg=0.5mg Cu

Antianemic

1961- August

2313

Daptomycin powder for concentrate for solution for infusion (350mg/500mg per vial)

For the treatment of complicated skin and skin structure infections and for staphylococus aureus bloodstream infections (bacteremia).

28.01.08

2314

Dimetridazole

Growth promotant in poultry.

1975-August

2315

D-trans Fentantyl Transdermal patches

For pain.

05/04/2006

2316

Estradiol topical emulsion 2.5mg/gm

Vasomotor symptoms Associated with menopause.

16.03.07

2317

Fenbendazole + oxyclozamide susp. & Bolus

i)-1ml of suspension fenbendazole-2.5% w/w,1.5%w/v, oxyclonazide-7.5%w/v,4.5%w/v, ii)-Each uncoated bolus contains; fenbendazole-175mg, oxyclozamide-625mg

In treatment of roundworms, lungworms, fluke in cattles & sheep only.

04/10/1999

2318

Feracrylum 3% solution

For the management of post-operative wounds cuts, Abrasions as a Haemostatic Agent cum anti-septic.

13.02.2002

2319

Flumethrin 1% solution

Each 100ml contains; flumethrin-1gm

Management of all tick species on the body of cattle.

29/10/1997

2320

Fluphenazine Decanoate

Anti-psychotic

1972-September

2321

Fluprednylidene-21-Acetate

Topical corticosteroid- Indicated in the treatment of allergic inflammmatory dermatoses.

1977-December

2322

Formestane depot inj. (i.m)

Each vial contains; formestane sterile-250mg

For the treatment of advance stage of breast cancer in women with natural or artificially induced post menopausal status.

06/03/1995

2323

Haemophilus type-b conjugate vaccine (finished formulation)

For the indication in infants from 2 months for the prevention of invasive disease such as meningitis,septicemia epiglotitis.

13/12/1994

2324

Ivermectin (6mg) tablets

6mg

2004-June

2325

Ivermectin concentrate solution/injection

Ivermectin concentrate solution-10% w/v, ivermectin injection-1% w/v.

Anthelmintic- Indicated for the control of various helminthic infestations such as round worm, lung worm of sheep, cattle, horse, swine, sucking lice, mange of pigs, dogs, ticks of sheep & cattle.

1985-October

2326

Loteprednol etabonate ophthalmic suspension

Each ml contains; loteprednol etabonate-2mg,5mg

2% suspensionshall be indicated in treatment of seasonal allergic conjuctivitis and 0.5% suspension is indicated for treatment of post operative inflammation following ocular surgery.

15-03-2002

2327

Metformin ER tablet 750mg (Additional strength)

As an adjunct to diet and exercise to improve glycemic control in adult patients with Type II Diabetes.

25.09.14

2328

Methylprednisolone

Corticosteroids- Indicated for conditions requiring glucocorticoid activity including collagen disease, allergic disease, hypersensitivity reactions.

1978-March

2329

Moxifloxacin hcl

Each film coated tab contains; moxifloxacin-400mg

By RMP- in acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia in adults above 18 years of age.

06/06/2001

2330

Nicardipine retard caps.

Each retard cap contains; nicardipine hcl-40mg,30mg (as pellets)

Management of hypertension and angina pectoris.

09/10/1996

2331

Nifedipine sustained release tablets

Each sustained release tab contains; nifedipine-20mg

1989-November

2332

Norethisterone acetate and ethinyl oestradiol

Not a oral contraceptive

Menstrual & gynaecological disorder.

1962- November

2333

Olazapine lyophilized powder for im inj.

Each vial of powder for inj.contains; olanzapine-5mg,10mg

For rapid control of agitation, disturbed behaviour in patients with schizophrenia when oral therapy is not appropriate.

03/06/2003

2334

Peopleomycin injection

Anti cancer- Indicated in the treatment of prostatic carcinoma, breast cancer, malignant lymphoma, melanoma and carcinomas of the head, neck and lungs.

1987-February

2335

Pitavastatin Tablet 4mg

An adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglyceride TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperliÞ¡

23.10.12

2336

Polyestradiol phosphate injection

Anti cancer drug- Indicated in the treatment of prostatic carcinoma.

1986-July

2337

Polyglycolic acid sutures

Sutures

1973- May

2338

Quinestrol

25mcg tablets daily for 2 months

Oestrogenic steroid

1971- July

2339

Ramipril (5mg) + Telmisartan (40mg) tablet

For Hypertension.

11/05/2005

2340

Rice based O.R.S

Rice based ORS citrate containing each sachet NaCl-3.5g, KcL-1.5g, sodi.citrate-2.9g, extruded rice-50g Rice based ORS electrolytes containing each sachet Nacl-1.25g, kcl-1.50g, sodi.citrate-2.90g, extruded rice-50g

09/12/1993

2341

Risperidone prolonged release suspension for injection (Deep Intramuscular Deltoid route using appropriate safety needle) (Additional route of administration)

Same as already approved

19.12.13

2342

Rivastigmine caps

Each hard capsule contains; rivastigmine as the hydrogen tartrate salt-0.5mg,1mg,1.5mg,3mg,4mg,5mg,6mg

Treatment of patients with mild to moderate dementia of Alzheimer type.

31/07/1998

2343

Ropinirole ER Tablet 1 mg. (Additional Strength)

Same as approved

04.01.11

2344

Sodium Iothalamate

Angiography

1965- August

2345

Sodium valporate

For additional indications; manic episodes associated with bipolar disorders.

17-07-2000

2346

Sterillium rubin disinfectant for hands.

20/05/1992

2347

Terbutaline Sulphate

Tablet-Terbutaline Sulphate-2.5 & 5mg, Syrup-Each mL contains; Terbutaline Sulphate-0.3mg

Anti-asthmatic drug- indicated in the treatment of asthma.

1979-November

2348

Thiothixene

10 mg tabs

Schizophrenic (anti-psychotic agent).

1967- December

2349

Tropicamide sterile

Tropicamide USP-1% w/v and 0.5% w/v.

For mydriasis and cycloplegia in diagnostic procedures.

1990-March

2350

2-Bromo-2-nitropropan-1,3-diol

Preservative

1972-September

2351

Altretamine caps 50mg

50mg

For palliative treatment of patients with persistent or recurrent ovarian cancer, following first line therapy with cisplatin and/or alkylating agent based combination.

29/03/1995

2352

Artesunate tabs

Each tab contains; artesunate-50mg

07/10/1996

2353

Bacillocid special

20/05/1992

2354

Balofloxacin Tablet 100mg

Each tablet contains; balofloxacin-100mg

For the treatment of uncomplicated urinary tract infectins (such as cystitis or urethritis)

23.12.09

2355

Beta-Methyl Digoxin

Cardiac glycoside

1977-December

2356

Bifonazole cream/solution/powder

1 gm of cream/powder contains-bifonazole-0.01gm, 1ml of solution contains; bifonazole-0.01gm

Skin mycosis caused by dermatophytes, yeast moulds, other fungi.

28-11-1997 to 28-11-1999

2357

Bleomycin-S ointment

Each 1 gm ointment contains; 5mg of bleomycin sulphate

For malignant skin tumour

11/10/1999

2358

Cefoperazone + sulbactum

Each 1.5gm & 2gm vials contains cefoperazone sod.eq.to cefoperazone 1g, 2g+sulbactum sod. Eq.to sulbactum 0.5g, 1g

For specific subset of patients immuno compromised febrile neutropenic cancer patients.

12/06/2001

2359

Clavulanic acid

Antibacterial agent- To be used in combination with amoxycillin only in the treatment of bacterial infection.

1987-February

2360

Dexamethasone trimethyl acetate

New salt for topical formulation.

1961- August

2361

Dextromethorphan Orodispersible strip 5.5mg/11mg

For the relief of persistent dry irritating cough in adult patients only.

28.01.08

2362

Diazepam + Sorbide Nitrate

Each tablet contains; Diazepam-2.5mg, Sorbide Nitrate-10mg

1979-December

2363

Divalproex sodium tablets

Each extended release tablet contains; divalproex sodium-750mg, 1000mg.

Additional indication- prophylaxis of migraine headache.

25/06/2004

2364

Epirubicin injection

Anti cancer drug- Indicated in the treatment of breast cancer, malignant lymphomas, soft tissue sarcoma, gastric lung and ovarian carcinomas.

1986-July

2365

Erlotinib HCl Tablet 150 mg (Additional Indication)

Monotherapy for the Maintenance Treatment of Patients with locally advanced metastatic non-small lung cancer whose disease has not progressed after four cycles of Platinum based First Line Chemotherapy.

04.01.11

2366

Isoprenaline sulphate

Cardiac drug

1970- April

2367

Fluorometholone + gentamicin

Each ml contains; fluorometholone USP-1mg, gentamicin-3mg (as sulphate)

By RMP- the infection of the anterior segment of the eye due to bacteria susceptible to gentamicin.

28-07-2000

2368

Indomethacin

Anti-rheumatic, anti-inflammatory.

1965- August

2369

Intralipid (30%) intavenous fat emulsion

Each 100ml contains; purified soyabean oil EP(30g), purified egg phospholipids EP(1.2g), glycerol BP-1.67g

For the patients with essential fatty acid deficiencies who can not maintain or restore normal essential fatty acids by oral intake.

12/05/2005

2370

Ketamine hydrochloride

Anaesthetic agent

1971- August

2371

L-Asparaginase

Anticancer

1973-May

2372

Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler (100mcg/capsule) (New Dosage Form)

As approved.

16.03.07

2373

Micronised Purified Flavonoid Fraction of Rutacea 1000mg (MPFF) (Amendment)

Each film coated tablet contains; Diosmin 90% and Hesperidine 10% of Micronised Purified Flavonoid Fraction of Rutaceae 1000mg (MPFF)

Acute hemorrhoid piles.

20.12.2013

2374

Nicergoline dragees/sugar coated tablets

Each dragee/sugar coated tablet contains; nicergoline-5mg,30mg

Peripheral vasodilator- Indicated in the treatment of acute & chronic peripheral and cerebral vascular metabolic disorders, Raynaud's syndrome and all syndrome due to altered peripheral flow.

1985-October

2375

Nicotinic acid and laropiprant modified release tablet

Each modified release tablet contains; nicotinic acid-1000mg, laropiprant-20mg

i) For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low LDL-cholesterol) and in patients with primary hypercholesterolemia (heterozygoÞ¡

31.03.10

2376

Oxaliplatin freeze dried powder for i.v injectio

Each vial contains; oxaliplatin-50mg,100mg

For the treatment of advanced colorectal cancer.

26/10/1998

2377

Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R

For GERD.

08/04/2006

2378

Pemetrexed Disodium 500mg/100mg Powder for Injection

As monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has to progressed immediately following platinum based chemotherapy.

30.10.12

2379

Pentoxifylline

Vasodialator- indicated in the treatment of arterial and arteriovenous circulatory disorders.

1975-September

2380

Purified chick embryo cell (PCEC) tissue culture rabies vaccine

Indicated for treatment after exposure to rabbies for pre-exposure prophylaxis.

1989-December

2381

Sodium Iothalamate

Sodium Iothalamate oral solution-60% w/v (eq.to 360mg of iodine per ml)

1969- June

2382

Sorafenib tosylate tablet 200mg (Additional indication)

For the treatment of patients with locally advanced or metastatic differentiated thyroid carcinoma refractory to radioactive iodine.

25.09.14

2383

Sulfametopyrazine

The drug sulphametopyrazine to be used only in manufacture of tablets containing this drug in combination with pyrimethamin for the treatment of cases of malaria which are resistant to chloroquin.

1978-June

2384

Terbutaline nebulising solution

Terbutaline sulphate **, aqueous solution-10mg/ml

For acute asthama.

1990-March

2385

Tizanidine hcl tablet

Each tablet contains; tizanidine hcl-2mg,4mg

Painful muscle spasm, spasticity due to neurological disorders.

22/12/1993

2386

Torasemide tab

Each tab contains; torasemide-5mg,10mg (20mg,100mg, 10mg/ml-appr on 7-8-2004 to cipla)

For treatment of oedema associated with CHF, renal or hepatic disorders and essential hypertension.

09/06/2003

2387

Trihexyphenidyl hcl. Sustaine release tab

Sustaine release tab

1962- November

2388

Ziprasidone caps

Each cap contains ziprasidone hcl monohydrate eq.to ziprasidone-20mg,40mg,60mg,80mg

Treatment of schizophrenia.

15-03-2002

2389

Ambroxol + Guaiphenesin

Each 5ml contains; guaiphenesin-100mg, ambroxol hcl-15mg, ethanol 95% eq.to ethanol-5% v/v

By RMP- for treatment of cough

18-08-2000

2390

Amoxapine tablets

Each tablet contains; amoxapine-25mg,50mg,100mg,150mg

Anti depressant- Indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depression, depression accompanied by anxiety and agitation.

1985-November

2391

Ampicillin

Oral synthetic penicillin.

1965- August

2392

Aripiprazole tab

Each uncoated tab contains; aripiprazole-10mg,15mg,20mg,30mg

For the treatment of schizophrenia.

11/06/2003

2393

Arteether injection 150mg/mL

Indicated for the treatment of severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only.

03.12.2010

2394

Articaine hydrochloride

Local anaesthetic agent- Indicated for spinal infiltration, dental surgical & epidural anaesthesia.

1986-August

2395

Bacillus calmette and geurin vaccine (immucyst, BCG therapeutics)

27mg dry weight per vaccine

Anti cancer- To be indicated for intravesical use in the treatment of primary and relapse carcinoma in-situ of the urinary bladder.

22/06/1992

2396

Clobazam tablets

Each tab contains; clobazam-5mg,10mg,20mg.

Acute and chronic anxiety states and as an adjunctive therapy in patients with refractory epilepsy.

11/11/1997

2397

Deferasirox Dispersible tablet 100/400mg (Additional indication)

Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia (NTDT) syndromes aged 10 years and older.

26.09.14

2398

Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection

For the treatment of acute colicky pain in adults.

28.01.08

2399

Famotidine injection

Each ml of famotidine injection contains; famotidine-10mg

1990-April

2400

Finasteride tabs

Each film coated tablet contains; finasteride-5mg

Benign prostatic hypertrophy only.

09/10/1996

2401

Flavonoids extracted from Rutacea (Aurantiaceae) containing a standard amount of diosmin

Haemorrhoids- Indicated in the treatment of haemorrhoids.

1978-June

2402

Flupenthixol

Neuroleptic agent- indicated in psychotic and schozophrenic cases where sedative and hypnotics effects are contra-indicated.

1977-January

2403

Glycopyrrolate

Each mL contains; Glycopyrrolate-0.2mg

Anaesthetic agent- for use as a pre operative antimuscarine to reduce salivary, tracheobronchial & phyrigeal secretions, arrhythmias & brodycardia associated with reversal o muscle relaxant.

1979-December

2404

Lactobacillus sporogenes

Each tablet contains; lacbon-50 million, 100 million.

1971- October

2405

Metformin Hcl.

0.5gm

Oral hypoglycemic agent.

1961- September

2406

Methylprednisolone acetate

40 mg/ml

Corticosteroid

1962- November

2407

Methylprednisolone Tablet 8mg

Each tablet contains; methylprednisolone- 8mg

Indicated for conditions require glucocorticoid activity including collagen disease, allergic disease, hypersensitivity reactions.

01.09.09

2408

Micronised Purified Flavonoid 1000mg (MPFF) (Amendment)

Each film coated tablet contains "Diosmin 900mg and Flavonoids expresses as Hesperidine 100mg of Micronised Purified Flavonoid Fraction of Rutaceae 1000mg (MPFF)".

Acute hemorrhoid piles.

30.06.2014

2409

Misoprostol

Each uncoated tablet contains; misoprostol-200mcg

Deodenal gastric and NSAID induced ulceration prophylaxis.

27-06-2001

2410

Montelukast Granules (4mg/pack)

Each sachet of granule contains; montelukast sodium eq.to montelukast-4mg

For Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older.

16/05/2005

2411

Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop

For the reduction of post operative inflammatory conditions of the eye.

05.01.11

2412

Nimesulide injection

Each 1ml contains; nimesulide-75mg

By RMP only- for short term treatment of post operative pain in adults only.

29/06/2004

2413

Ondansetron Hydrochloride Oral Spray 2mg (Each spray delivers ondansetron-2mg)

For chemotherapeutic induced nausea and vomiting.

08.11.12

2414

Oseltamivir formulation (additional indication)

For Prophylaxis of influenzae in adult and children >14 years of age.

24/04/2006

2415

Oxprenolol Hydrochloride

Beta-blocker

1973-June

2416

Pantoprazole + Amoxycillin + Tinidazole

Each combikit contains; pantoprazole-40mg (two eneteric coated tab), amoxycillin-750mg (two film coated tab), tinidazole-500mg(two film coated tab)

15-10-1999

2417

Polonosetron (As Hcl.) For Injection 0.25mg/5ml

Chemotherapy induced nausea & vomiting.

20.03.07

2418

Protryptyline hydrochloride

Protryptyline hydrochloride-5mg, 10 mg

1969- June

2419

r Hu erythropoietin injection

Each lyophillised 2ml vial contains; r hu erythropoietin-2000iu,4000iu, mannitol-40mg, NaCl-7mg, monobasic sod.phosphate-2.8mg, diabesic sod.phosphate-8mg, human albumin-5mg

In the treatment of anaemia due to chronic renal failure and end stage renal disease.

27/01/1993

2420

Somatostatin i.v infusion

Severe acute haemorrhage from oesophegal varices/gastric or deodenal ulcers or acute erosive or haemorrhagic gastritis adjuvant treatment in pancreatic billiary and intestinal fistulae. Prophylaxis and treatment of postoperative complication following panÞ¡

24/04/1995

2421

Sphaeranthus indicus extract tablets

Each tablet contains; sphaeranthus indicus extract-700mg

For the management of psoriasis.

08.01.10

2422

Trazadone

Anti depressant- Indicated in the treatment of all types of depression.

1987-March

2423

Trimethoprim + Sulfamoxole

Indicated in the treatment of respiratory tract infection, urogenital infections, G.I. Tract infections etc.

1975-September

2424

Vindesine sulphate injection

Each vial contains; vindesine sulphate-1mg,5mg

Acute lymphocytic leukemia of childhood resistant to vincristine sulphate. Non hodgkins lymphomas, malignant melanoma, non-small cell carcinoma of the lung, blast crisis of chronic granulocytic leukemia and carcinoma of the breast.

28/10/1998

2425

Vitamin C slow release tabs

Each slow release tabs contains vitamin C-500mg

Vitamin C deficiency

06/03/2002

2426

Arsenic trioxide inj

Each ml contains; arsenic trioxide-1mg

For induction of remission and consolidation in patients with acute promyelocytic leukemia.

12/06/2003

2427

Atazanavir (100/150/200mg)

Anti-HIV in adults.

24/04/2006

2428

Bortezomib for injection (3.5mg/vial)

For the treatment of myeloma patients.

18/05/2005

2429

Caffeine citrate oral solution

Each ml contains; caffeine citrate USP-20mg (eq.to 10mg caffeine base)

For the short treatment of apnoea of prematurity in infants between 28 and <33 weeks gestational age.

21.07.09

2430

Chlorprothixene

Tab-50mg & vial-50mg

Anti-depressant.

1961- September

2431

Cifixime 200mg + Erdosteine 300mg Capsules

Acute Exacerbation of chronic bronchitis.

21.03.07

2432

Cloxacillin

Oral synthetic penicillin.

1965- August

2433

Combipack of aminoacid & glucose inj.with electrolytes and IV fat emulsion.

Two bottles in a kit, one bottle of (1000ml) contains aminoacid (7%w/v) glucose (10%) with electrolytes injectable filled up to 750ml. Second bottle is supplied with fat emulsion (20%w/v) in 250ml.

By RMP- short term parenteral nutrition via peripheral route, pre & post opertaive nutrition in cancer [patients, burns patients, short bowel syndrome, inflammatory bowel disease, transition period between i.v nutrition and normal food.

28-08-2000

2434

Diazinon (Neocidol)

Diazinon-20% w/w

Indicated in the treatment for the control of ectoparasites in live stock.

1990-April

2435

Everolimus dispersible Tablet 0.1mg/0.25mg (additional Indication)

For the prophylaxis of organ rejection in patients receiving a hepatic transplant. In liver transplantation, Everolimus should be used in combination with tacrolimus and corticosteriods.

21.08.15

2436

Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. To Elemental Zinc 22.5mg Tablet

For the treatment of iron deficiency anaemia.

05.01.11

2437

Fluconazole capsules/injection

Each capsule contains; fluconazole-50mg,100mg,200mg, fluconazole i.v injection 100ml,200ml contains; fluconazole-2mg/ml

For the treatment of systemic candidiasis, mucosal candidiasis, cryptococosis, prevention of fungal infections in patients with malignancy.

28/01/1993

2438

Fusidic acid hemihydrate

Bacterial infection of the eye caused by susceptible organism in conjunctivitis, blepharitis, stykeratitis, dacryocystitis. It can be used for prophylaxis in ophthalmic surgery and in connection with removal of foreign bodies.

1992-March

2439

Human recombinant granulocyte colony stimulating factor (Hu r GCSF) inj.

Each ml contains; Hu r GCSF-300mcg

For decreasing the severity of cytotoxic chemotherapy induced neutropenia, acceleration.

28-06-2001

2440

Ibandronic acid injection

Each 6ml vial contains; ibandronic acid mono sodium salt monohydrate eq.to ibandronic acid-1mg/ml

Oncologists-for treatment of tumour induced hypercalcaemia with or without metastasis.

01/06/2004

2441

Imatinib mesilate100/400mg tablets and 100 mg capsules (Additional indication)

Treatment of Paediatric patients with newly diagnosed Philadelphia chromosome positive acute Lymphoblastic Leukaemia (Ph+ALL) integrated with chemotherapy.

09.09.14

2442

Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 1 g Powder for Injection (Additional strength)

For the treatment of serious lower respiratory tract infections, urinary tract infections, intra-abdominal, bone and joint infection, endocardities and bacterial septiceimia.

28.06.12

2443

Imipramine Pamoate

Each capsule contains; i)-Imipramine Pamoate 112.50mg eq to 75 mg of Imipramine hcl, ii)-Imipramine Pamoate 224.5mg eq to 150 mg of Imipramine hcl.

Antidepressant indicated in the treatment of allform of depression

1979-May

2444

Loxitalmic Acid

For cerebral angiography and urography (X-ray contrast media)

1977-April

2445

Micronised Purified Flavonoid 1000mg (MPFF) (Amendment)

Each film coated tablets contains Micronized - purified Flavonoid Fraction 1000mg composed of Diosmin 900mg (90%) and Flavonoids expresses as Hesperidine 100mg (10%).

Acute hemorrhoid piles.

26.12.2014

2446

Naltrexone hcl tabs

Each uncoated tab contains; naltrexone hcl-50mg

In the treatment of narcotic antagonist and alcohol dependence.

11/10/1996

2447

Nicotine transdermal therapeutic system

17/05/1995

2448

Nitrazepam

Epileptic

1973-June

2449

Oxyclozanide

1972-November

2450

Pantoprazole tablets

Each gastro resistant tablet contains pantoprazole sodium sesquihydrates eq.to pantoprazole-40mg,20mg

For the treatment of gastric ulcer, duodenal ulcer, moderate and severe reflux oesophagitis.

09/12/1998

2451

PEG-electrolytes (iso-osmotic laxative)

Short term treatment of chronic constipation.

19/12/1997

2452

Pollidacanol injection

Anti sclerosis- Indicated in the treatment of sclerosation of various cutaneous veins and oeseophageal varicose haemorhoids and haemangiomas.

1987-March

2453

Reproterol hydrochloride

Bronchodilator- Indicated in the treatment of conditions involving reversible airways obstruction viz bronchial asthma, bronchitis etc.

1986-September

2454

Salbutamol sulphate B.P

Bronchial asthma

1971- October

2455

Salcatonin

Synthetic Salmon calcitonin-polypeptide hormone.

1978-July

2456

Satranidazole tablets/bulk

Each tablet contains; satranidazole-150mg

1985-November

2457

Sodium tolbutamide

Injection-diagnostic

Diagnostic

1962- November

2458

Sulpiride capsules

Each capsule contains; sulpiride-50mg, 200mg(appr. On 14-3-2000)

In treatment of mild to moderate depression and neurotic depression.

26-10-1999

2459

Ketorolac sterile ophthalmic solution 0.5%

Ketorolac tromethamine -0.5%

For the relief of occular itching due to seasonal allergic conjunctivitis only.

01/03/1996

2460

Labetolol tablets

Each tablet contains; labetolol hydrochloride-50mg,100mg,200mg

1987-January

2461

Temozolomide powder for solution for infusion

Each vial contains; temozolomide-100mg

For the treatment of; i) Adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. Ii) Children from the age of three years, adolescents and adult patients with malignant giÞ¡

28.05.10

2462

Thiamine propyl disulphide

1969- July

2463

Tranexamic acid tablets/i.v inj.

Each tab contains/cap tranexamic acid BP-250mg, 500mg

Haemorrhage or risk oh haemorrhage in increased fibrinolysis of hereditatory angioneurotic oedema.

06/03/2002

2464

Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops

For decrease of intraocular pressure in patients with open angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta blockers or prostaglandin analogues.

28.01.08

2465

Trofosfamide

indicated in the treatment of lymphogranulomatosis, lymphosarcoma, reticulosarcoma,ovarian carcinoma, carcinoma of breast.

1975- November

2466

Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet

For osteoporosis.

01/02/2006

2467

Allopurinol

Each tablet contains; 100mg of allopurinol

In the treatment of gout and secondry hyperuricaemia.

1969- March

2468

Aluminium salicylate

Anti-diarrhoeial, antiseptic.

1965- February

2469

Amineptine tablets

Each tablet contains; amineptine hcl-100mg

Anti depressant- Indicated in the treatment of all types of depression.

1988-January

2470

Arteether injection i.m

Each ampoule contains; arteether-150mg

Same as artesunate (Antimalarial)

14/01/1997

2471

Betahistine hcl

Each tablet contains; 16mg

20-01-2000

2472

Betamethyl Digoxin

Each tablet contains; Betamethyl Digoxin-0.1mg & 0.5mg, Liquid; Betamethyl Digoxin-0.6mg, Injection; Betamethyl Digoxin-0.1mg

1978-March

2473

Bimaprost ophthalmic soln 0.03%

Each ml contains; bimaprost-0.3mg

For reduction of elevated IOP in patients with open angle glaucoma or ocular hypertension.

08/01/2002

2474

Bisoprolol

2.5mg tablets

NOC issued for the additional indication of congestive heart failure (CHF).

19-01-2001

2475

Carfilzomib sterile lyophilized powder for injection 60mg/vial (50ml vial)

Each vial contains; Carfilzomib 60mg

Relapsed or refractory multiple myeloma i) Carfilzomib for injection is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one Þ¡

17.01.17

2476

Cefaclor modified release tablet

Each MR tablet contains; cefaclor-375mg,750mg.

27/01/1995

2477

Cefadroxil capsules/tablets/oral suspension/dispersible tablets

Tablets/capsules-500mg,1gm, oral suspension-125mg/5ml,250mg/5ml, dispersible tablet contains; cefadroxil eq.to cefadroxil anhydrous-250mg(TPL-11-8-94)

Antibiotic- Indicated in the treatment of UTI, skin & skin structure infections caused by S.cocci or streptococci, pharyngitis, tonsilitis, respiratory tract infections only.

1989-February

2478

Colistin sulphomethate + Dibucaine

Each vial contains; Sterile powder of colistin sulphomethate sodium eq to 10,000,00 Units, Dibucaine Hcl-2mg

1980-February

2479

Dapagliflozin Tablet 5mg/10mg

Each film coated tablet contains; dapagliflozin propanediol monohydrate eq.to dapagliflozin-5mg, 10mg

"In adult aged 18 years and older with Type-II diabetic mellitus to improve glycemic conrol. As mono-therapy when diet and excercise alone do not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate due to inÞ¡

25.02.15

2480

Estradiol valerate tab 1mg/2mg

1mg, 2mg

02/03/1998

2481

Ethacrynic acid USP

Each tablet contains; ethacrynic acid USP-25mg & 50mg

non-Thiazide saluretic diuretic.

1973-February

2482

Ethambutal dihydrochloride

100, 200 & 400 mg tablets

Mycobacterium tuberculosis.

1968- March

2483

Ferrous sulphate

150 mg sustained release

1971- January

2484

Fibrinolysin and Desoxy ribonuclease combined (Bovine)

Enzymes useful in removal of exudates and clots from wound and promote healing.

1962- February

2485

Fluconazole tabs/caps/inj.

Each cap/tab contains; fluconazole-50mg,100mg,200mg,150mg, Fluconazole i.v injection contains; fluconazole-2mg/ml

26/04/1993

2486

Fusafungine

Each Aerosol cartridge contains; Fusafungine Hcl-25mg

1977-March

2487

Fusidic acid eye drops

Each gm contains; fusidic acid BP-10mg

03/03/1992

2488

Garenoxacin Mesylate tablets 200mg

Each film coated tablet contains; garenoxacin mesylate eq.to garenoxacin-200mg

For the treatment of bacterial respiratory tract infection.

07.06.13

2489

ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength)

Same as Approved

02.01.08

2490

Levamisole + Mebendazole tablets

Each tablet contains; levamisole-50mg, mebendazole-200mg

1984-September

2491

Lynestrenol B.P.

Each tablet contains; Lynestrenol B.P-0.5mg

1975-March

2492

Mesterolone

Each tablet contains; Mesterolone-25mg

1981-March

2493

Methychlothiazide

2.5 to 5mg

Oral diuretic agent Longest duration: more sodium excretion less potassium loss.

1961- February

2494

Methyl Dopa

250 mg

Antihypertensive

1963- March

2495

Metifex drages

Each dragee contains; ethacridine lactate-100mg,200mg.

1983-June

2496

Metoprolol tartrate tablets

Metoprolol tartrate-50mg,100mg

1982-May

2497

Metronidazole + Spiramycin tablets

Each film coated tablet contains; spiramycin-0.75 MIU,1.50MIU, metronidazole-125mg,250mg

15/03/1994

2498

Naproxen

Approved old drug, now approved for-375mg tablets

1990- February

2499

Nitrofurantoin BP

Each Disc is in pregnated with Nitrofurantoin BP-100mcg, 200mcg

1974-March

2500

Paracetamol + diphenyl pyraline Hcl + Phenyl propanolamine Hcl

Each 5mL contains; Paracetamol-120mg, Diphenyl pyraline Hcl-1.5mg, Phenyl propanolamine Hcl-10mg

1976-May

2501

Pentoxifylline 400 dragees

Each dragee contains; pentoxifylline-400mg

1986-March

2502

Pitavastatin (1mg/2mg) Tablet

Each film coated tablet contains; pitavastatin calcium eq.to pitavastatin-1mg, 2mg

By RMP- for the treatment of familial hypercholesterolaemia.

14-01-2005

2503

Plerixafor Injection 20mg/ml

In combination with Granulocyte Colony Stimulating Factor (G-CSF) to enhance mobilisation of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous hematopoeitic stem cells transplantation in patients with non-Hodgkinâ??sÞ¡

31.01.12

2504

Pralidoxime iodide

Antidote for poisoning

1966- March

2505

Propofol clear soln for i.v inj.

Each ml of clear soln for inj.contains; propofol-50mg,200mg,400mg

For induction in veterinary practise only

10/01/2003

2506

Prothionamide B.P

Each tablet contains; prothionamide-125 mg

Anti T.B.

1972- June

2507

Raltegravir (as Potassium) film coated Tablets 400mgÂ

Each film coated tablet contains; raltegravir potassium 434.4mg eq.to raltegravir-400mg

In combination with other anti retroviral agents forÂ the treatment of human immunodeficiency virus (HIV-1) infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy.

27.01.10

2508

Rasagiline (as mesylate ) Tablet 0.5mg/1mg

Each tablet contains; rasagiline mesylate eq.to rasagiline-0.5mg, 1mg

For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa.

31.01.09

2509

Regorafenib Tablet

Each film coated tablet contains; regorafenib-40mg

For the â??treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapyâ?.

01.07.14

2510

Salbutamol Sulphate

Each 5 mL conatains; Salbutamol Sulphate eq to 50mg of Salbutamol

1979-January

2511

S(-) atenolol + Hydrochlorthiazide tablets

2004

2512

Sheep pox vaccine

1991- April

2513

Sildenafil Citrate 20mg Tablet

Each film coated tablet contains; sildenafil citrate eq.to sildenafil-20mg

For the treatment of pulmonary arterial hypertension (WHO group I) to improve excercise ability.

23.01.07

2514

Tetrabenazine

Each tab contains; tetrabenazine-25mg

In treatment of movement disorders associated with organic CNS conditions like Huntington's chorea, hemiballismus and senil chorea.

10/03/1999

2515

Tinazoline bulk/nasal drops

Tinazoline hcl-0.08% solution

Nasal decongestant-Acute cold vasomotor rhinitis to facilitate rhinoscopy and to aid drainage of secretions in affectious of the paranasal sinuses.

1985-August

2516

Tofacitinib Tablets 5 mg

Each film coated tablet contains; tofacitinib citrate eq.to tofacitinib-5mg

â??For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have hadÂ an inadequate response or intolerance to Methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic diseaseÞ¡

01.04.16

2517

Xanthinol nicotinate

1 ampl. 1 & 2 times daily

In treatment of peripheral and cerebral circulatory disturbances, thrombosis, embolism apoplexy and the consequences of apoplexy.

1967- February

2518

17Î²-estradiol intranasal spray

Each spray (0.07ml) delivers; 17-Î²-estradiol hemihydrate-150mcg

For treatment of oestrogen deficiency symptoms in post-menopausal women.

18-06-2003

2519

2-Pyrrolidone acetamide

Indicated in treatment for behavior and psychotic problems in old age and mental retardation in children

1977-December

2520

Aceclofenac + Paracetamol tablets

Each tablet contains; aceclofenac-100mg, paracetamol-500mg

RMP- for acute painful conditions in adults only.

08/07/2004

2521

Aprotinin

Acute Pancreatites.

1973-November

2522

Allergen Extracts

Contact allergic conditions- to be supplied to clinics & physician having facilities to conduct such test and prescription from the specialist.

1979-January

2523

Ambroxol + Guaiphenesin + Menthol + Pseudoephedrine

Ambroxol-30mg, guaiphenesin-100mg, menthol-01mg, pseudoephedrine-60mg

Cough congestion

29-10-1999

2524

Aminophylline CR 225/350mg

Asthma, COPD, Bronchitis.

21.03.07

2525

Amlodipine + benazepril hcl tabs/caps

Each cap contains amlodipine (as besylate)-2.5mg,5mg, benazepril-10mg,20mg

Hypertension

22-03-2002

2526

Amoscanate bulk/tablets

Each tablet contains; amoscanate-250mg

Indicated in treatment of adult hookworm infestation only.

1985-November

2527

Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores

For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea.

30.01.08

2528

Cefotaxime sodium

Antibiotic- Indicated in the treatment of patients with serious infections.

1987-April

2529

Ceftizoxime sodium sterile

Each vial contains; 500mg,1000mg.

3rd generation cephalosporin.

1990-May

2530

Clostebol acetate

Protein anabolizing agent- Preparation containing the drug with neomycin shall be indicated in the treatment of infected wounds and 1st and 2nd degree burns.

1986-September

2531

Dicloxacillin

Antibiotic- infection of respiratory tract, skin and mucosa infection, bone infection.

1978-July

2532

Diphenoxylate Hcl.

1969- July

2533

Everolimus Tablet 0.25 mg/0.5 mg/0.75 mg/1.0mg (additional Indication)

For the prophylaxis of organ rejection in patients receiving a hepatic transplant. In liver transplantation, Everolimus should be used in combination with tacrolimus and corticosteriods.

21.08.15

2534

Fluticasone furoate nasal spray

Each spray delivers; fluticasone furoate-27.5mcg

For the treatment of symptoms of allergic rhinitis.

20.03.09

2535

Formoterol fumarate

Each actuation delivers; formoterol fumerate-12 mcg

Bronchoconstriction in patients with reversible obstructive airway disease requiring long term bronchodilator therapy.

29-06-2001

2536

Fosfomycin trometamol sachets

Each sachet contains; fosfomycin trometamol 5.631gm eq.to fosfomycin-3gm

For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcus faecalis.

16.07.10

2537

Halquinol

Antiamoebic, antidysentric.

1965- September

2538

Intravenous fat emulsion (10%w/v)

Each 100ml contains; soyabean oil USP-10.0gm, egg lecithin-0.60gm, glycerol IP-2.5gm

By RMP- parenteral nutrition in critical care condition.

28-08-2000

2539

Nelfinavir 625mg tablet (addl.strength)

For HIV patients.

20/05/2005

2540

Nicorandil E.R Tablet (10mg/20mg)

Angina pectoris.

24/04/2006

2541

Pipazethate

Dragee-20mg, drops-40mg/ml

Antitussive.

1961- September

2542

Polio virus vaccine live (oral)

0.1 ml

Prophylactic, immunological

1962- November

2543

Progesterone micronized soft gelatin caps.

21/06/1995

2544

Purified Vi-capsular polysaccharide of salmonella typhi (vaccine against typhoid fever)

One vaccinating dose of 0.5ml;-purified vi-capsular polysaccharide of salmonella typhi-0.025mg, phenol-1.250mg, isotonic buffer solution qs-0.5ml

12/02/1993

2545

Reserpine + clopamide + dihydroergocristine

Diuretic

1971- October

2546

Saccharomyces boulardii (caps/sachets)

i)-lyophillized S.boulardii-282.5mg sachet, ii)-lyophillized S.boulardii-282.5mg caps

i)-For irritable bowel syndrome, ii)-antibiotic associated diarrhoea, iii)-diarrhoea due to enternal feeding in adults only.

18-12-1997 to 18-12-1999

2547

S (+) Etodolac 300mg + Thiocolchicoside 8mg Tablet

For the treatment of patients with acute painful musculoskeletal conditions.

05.01.11

2548

Sodium Cromoglucolate

Anti-asthmatic drug

1972-November

2549

Sparfloxacin tablets

Each tab contains; sparfloxacin-100mg,200mg,400mg (100mg,400mg-Unichem 20-7-99)

Community acquired pneumonia, acute exacerbation of chronic bronchitis, other lower respiratory tract infection caused by susceptible bacteria, acute sinusitis genococcal and non genococcal urethritis in males uncomplicated UTI skin soft tissue infectionsÞ¡

11/11/1996

2550

Tacrolimus Capsules 0.25mg

For the prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplant.

03.12.12

2551

Tapentadol Extended release tablet 100/150/200mg (Additional strength)

For use in in-patients under hospital setting for severe acute pain for a period not exceeding 5 days.

09.12.13

2552

Trimethoprim + Sulphadoxine

Bacterial infections in cattle.

1973-September

2553

Abacavir sulphate tablets & bulk

Each tablet contains; abacavir sulphate eq.to abacavir-300mg

HIV infection in combination with other antiretroviral agent.

22-03-2002

2554

Amantadine Hydrochloride

Parkinsonism

1972-December

2555

Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores

For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea.

31.01.08

2556

Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler

For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate.

05.01.11

2557

Botulinum toxin type-A

Additional indication- adult spasticity.

2004

2558

Candesartan cilexetil

Each tablet contains; candesartan cilexetil-4mg,8mg,16mg

By RMP- for mild to moderate essential hypertension only.

31-08-2000

2559

Carbocisteine

Mucolytic agent- Indicated as an adjunctive therapy in respiratory disorder.

1987-August

2560

Cetrorelix Acetate injection 0.25mg/0.5ml in 0.5 ml prefilled syringe. (Additional pack size)

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.

26.08.15

2561

Clindamycin + Tretinoin topical gel

10gm tube contains; clindamycin-1%, tretinoin-0.25%

Mild to moderate acne vulgaris only.

18/11/1996

2562

Coligen (Escherichia coli bacterin vaccine)

For the prevention of calf & cows, due to infection with enteropathogenic, E.coli organism.

1990-June

2563

Diclofenac Sodium Injection 75mg/2ml

For acute painful conditions in postoperative pain, renal colic and acute exacerbation of gouty arthritis.

04.12.12

2564

Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream

Acute Musenlosleteal pain.

21.03.07

2565

Fenbendazole

Anthelmetic- indicated to treat gastro-intestinal nematodes infections of live stocks.

1979-January

2566

Flecainide acetate

Each tablet contains; flecainide acetate-100mg, Each ampoule contains; (15ml) inj.flecainide acetate-150mg/ml

Antiarrhythamic

26/03/1993

2567

Hydroxyzine hydrochloride sustained release tablets

Each uncoated sustained reelase tablet contains; hydroxyzine hydrochloride USP-25mg, 50mg, 75mg

For the management of pruritis due to allergic conditions such as chronic urticaria and atopic and contact dermatosis, and in histamine-mediated pruritis.

26.08.10

2568

Isepamicin injection

Each ml contains; isepamicin sulfate eq.to 100mg,250mg of isepamicin.

LRTI, intra abdominal infection, UTI, skin & soft tissue infection and septicemia.

26-12-1997 to 26-12-1999

2569

Lamivudine + zidovudine tablets

Lamivudine-150mg, zidovudine-300mg

For the treatment of HIV infection

26-11-1999

2570

Levodopa + Benserazide capsules

Each capsule contains; levodopa-100mg,200mg, benserazide-25mg,50mg

Parkinsonism- To be used only in the manufacture of capsules containing this drug in combination with levodopa for the treatment of Parkinson's disease.

1985-November

2571

Nicotine ploacrilex lozenges

Each lozenges contains; nicotine polacrilex eq.to nicotine-2mg, 4mg

To reduce withdrawal symptoms, including nicotine craving, associated with quitting the smoking.

20.02.09

2572

Olanzapine pamoate Prolonged release powder for suspension for I.M injection (combi pack)

Each combipack contains a. Vial of Olanzapine pamoate Prolonged release powder for suspension. Each vial contains: Olanzapine pamoate monohydrate eq to Olanzapine 210mg/300mg/405mg. After reconstituton each mL of suspension contains 150mg. b. Vial of vehiÞ¡

For the treatement of schizophrenia.

14.10.14

2573

Pargyline Hcl.

Anti-depressant

1965- November

2574

Parvo-virus vaccine (killed)

Indicated in the treatment of parvo-virus infectious in dogs only.

1986-October

2575

Pivazide

50mg, 1-2 tab t.i.d

Cardiac drug-reduces intensity & frequency of anginal attacks.

1961- September

2576

Prazosin hcl (GITS) tablets

21/06/1995

2577

Rutin + viit. C + vit. K + dicalcium phosphate + carbazochrome

Tablet: Rutin 0.1g, vit. C- 0.1g, vit. K1- 2.5 mg, dicalcium phosphate-0.1g, carbazochrome-1 mg, Injection: vit. K1-5 mg, calcium lactuonate-100mg, carbazochrome-2.5mg, phenol-0.5%, lignocaine hcl.-1%

1969- July

2578

S(-) amlodipine (5mg) + atenolol(50mg) tab

Each tablet contains; S(-) amlodipine-5mg, atenolol-50mg

By RMP- for the treatment of essential hypertension & angina pectoris.

09/07/2003

2579

Sevelamer (400mg/800mg) tablet

Each film coated tablet contains; sevelamer Hcl-400mg, 800mg

For the control of serum phosphorus in patients with chronic kidney disease on hemodialysis.

20/05/2005

2580

Sotalol

Beta-blocker- indicated in the treatment of angina pectoris, hypertension, cardiac arrythmias.

1978-August

2581

Sparfloxacin

Each 5ml contains; sparfloxacin-0.3% w/v

Bacterial conjunctivitis, bacterial corneal infections like keratitis, kerato-conjunctivitis and corneal ulcer caused by suscepible micro organism.

2001- July

2582

Tranylcypromine sulphate

10 mg tabs

Anti-depressant

1962- December

2583

Yeast Tannic Acid Compound

Anti-diarrhoeal agent.

1971- October

2584

Acebutolol capsules/injection

Each capsule contains; acebutolol hcl eq.to 100mg,200mg,400mg acebutolol, Each ml contains; eq.of 5mg of acebutolol.

Anti hypertensive agent- Indicated in the management of all grades of hypertension, angina pectoris and control of tachyarrhythmias.

1985-December

2585

Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet

For the treatment of mild to moderate hypertension.

05.01.11

2586

Azelaic acid (20% w/w) cream

Each gm of cream contains; azelaic acid-0.2gm

By RMP only- for the topical treatment of mild to moderate inflammatory acne vulgaris.

08/07/2003

2587

Bambuterol hcl tablets

i)-Each uncoated tab contains; bambuterol hcl BP-10mg,20mg, ii)-Each ml of oral suspension contains; bambuterol hcl-1mg(appr. On 27-9-2000)

Bronchodilator.

13-12-1999

2588

Betahistine mesilate Tablet

Each tablet contains; betahistine mesilate-6mg, 12mg

For the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo.

24.02.09

2589

Calfactant intratracheal suspension

Each ml of suspension contains; total phospholipids-35mg (containing 26mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine), protein-0.65mg (including 0.26mg of surfactant associated proteins B)

i) As a prophylaxis therapy for premature infants < 29 weeks of gestational age at significant risk for respiratory distress syndrome (RDS). Ii) For the treatment of infants â?¤ 72 hours of age with RDS (confirmed by clinical and radiologic findings) and reÞ¡

16.12.10

2590

Canine distemper killed canine hepatitis leptorpira parvo virus vaccine

Vaccine against canine distemper parvo viru, infectious canine hepatitis and leptospirosis.

1986-November

2591

Cephalexin

Broad spectrum antibiotic.

1971- October

2592

Clemastine

Anti-histaminic- indicated in the treatment of all allergic rhinitis, urticaria, pruritus, itching, dermatoses.

1979-April

2593

Complex 15 cream

Phospholipid-for the treatment/immediate relief of mild to moderate to severe dry skin as is associated with xerosis, dry eczema, senile dry skin, itchthyosis neurodermatitis sputitic as adjuvant therapy in atopic eczema.

10/01/1997

2594

Daunorubicin

Anticancer

1972-December

2595

Diazoxide

Antihyertensive agent- indicated for reduction of blood pressure in malignant hypertension.

1978-August

2596

Diphenhydramine (as methyl sulpho methylate/methyl sulphate)

Tablet-60 mg, Syrup-480mg/100ml

Antihistaminic.

1961- September

2597

Eberconazole cream (1%)

Dermatophyte infection of skin such As T-corporis, T-c, T-Pedis.

22.03.07

2598

Esomeprazole + Domperidone SR capsules

Each capsule contains; esomeprazole mag.eq.to esomeprazole-20mg,40mg (as enteric coated pellets), domperidone maleate BP eq.to domperidone-30mg sustained release.

By RMP- for the treatment of adult patients with gastroesophagal reflux disease (GERD) not responding to esomeprazole alone.

2004

2599

Exenatide 2 mg powder and solvent for prolonged release suspension for injection in a prefilled pen (s.c. Injection) (Additional strength)

For treatment of type 2 diabetes mellitus in combination with Metformin, Sulphonylurea, Thiazolidinedione, Metformin and Sulphonylurea, Metformin and Thiazolidinedione In Adults who have not achieved adequate glycemic control on maximally tolerated doses Þ¡

09.09.15

2600

Isoflurane

Used for induction and maintenance of general anaesthesia.

1990-July

2601

Loteprednol etabonate ophthalmic solution & bulk (0.2% & 0.5%)

Each ml contains; loteprednol etabonate-2mg,5mg

0.2% suspension shall be indicated in treatment of seasonal allergic conjuctivitis & 0.5% suspension is indicated for treatment of post-operative inflammation following ocular surgery.

15-03-2002

2602

Mecobalamin 1500mcg + Alpha Lipoic Acid 100mg + Benfothiamine 15mg + B6 3mg + Calcium Pantothenate 25mg + Folic Acid 1.5mg + Zinc oxide 22.5mg + Chromium picolinate 65mcg + Inositol 10mcg + Lutein 5mg capsule

For Vitamins and Minerals deficiency states in adult patients.

30.01.08

2603

Megestrol Acetate Oral Suspension 400mg per 10ml (10 & 20mg Sachet)

For the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of cancer or acquired immunodeficiency syndrome (AIDS).

05.12.12

2604

Nadifloxacin Gel 1%

Acne vulgaris.

10/05/2006

2605

Nelfinavir mesylate tabs

Each tab contains; nelfinavir mesylate eq.tonelfinavir-250mg

HIV-1 infected patients with advanced or progressive immuno-deficiency in combination with anti-retroviral nucleoside analogues.

02/07/2001

2606

Norethynodrel & Ethinyloestradiol-3-methyl-ether

Oral progestational agent.

1962- December

2607

Nova-T

Contraceptive

1987-August

2608

Oral typhoid vaccine caps (finished formulation)

Prophylaxis of typhoid

17/05/1993

2609

Phenylmethylamine-p-amino benzene sulphonate

1969- July

2610

Povidone iodine sterile ophthalmic prep solution

Each ml contains; povidone iodine IP-5.0% w/v

For prepping of the periocular region and irrigation of the ocular surfaces.

22/11/1996

2611

Practolol

Cardiac Drug.

1973-November

2612

Rivastigmine transdermal patch. (Additional indication)

Each Transtermal patch of 15cm2 contains Rivastigmine 27mg

For the treatment of patients with severe dementia of the Alzheimer's type.

28.10.14

2613

Sodium phosphate

Each ml contains; monobasic sodium phosphate monohydrate-276mg, dibasic sodium phosphate heptahydrate-268mg.

By-RMP- patients on parenteral nutrition, increased excretion and decreased absorption of phosphorus, 'X' linked familial hypophosphalaemia decreased respiratory alkalosis, chronic alcoholism and patients of phosphate binding agents.

31-08-2000

2614

S(-)Pantoprazole (10mg/20mg/40mg) tablet

Each enteric coated tablet contains; S(-) pantoprazole sodium eq.to S(-) pantoprazole-10mg,20mg,40mg

For the treatment of gastric ulcer, duodenal ulcer & GERD.

20/05/2005

2615

FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule

For Hypercholesterolemia.

26/07/2005

2616

Terlipressin acetate injection i.v

Each vial contains; terlipressin acetate-1mg

In the treatment of bleeding oesophagal varices.

22/07/1995

2617

Amoxycillin + Clavulanic acid

Amoxycillin-250mg, clavulanic acid-125mg

13-12-1999

2618

Bleomycin

Anticancer

1973-December

2619

Creatine phosphate injection

Each vial contains; creatine phosphate-500mg,1gm

Endogenous biochemical substance- Deficient striated muscle activity, coadjuvant in the treatment of myocardial disorders for addition to cardioplegic solution as a means of protection in heart surgery.

20/01/1997

2620

Dabigatran Etexilate Mesilate hard gelatin capsule 75/110/150mg (Additional Indication)

1. Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death. 2.Prevention of recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE) and related death.

17.11.14

2621

Edrophonium chloride

10 mg

Cholinergic & curare antagonist.

1961- October

2622

Flumequine

Respiratory tract infections.

1987-September

2623

Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250 /500mcg) dry powder inhaler

For Asthma & COPD.

10/05/2006

2624

Glimenclamide + Metformin tabs

Each tab contains; glibenclamide-2.5mg,5mg, metformin-400mg,500mg

Non insulin dependent diabetes mellitus patients poorly controlled with sulphonyl urea or biguanide alone.

26/11/1996

2625

Heparin sod. & 0.9% sod.chloride inj.

Each ml contains; heparin sod.-2 USP heparin units, sod. Chloride-9mg

As an aid in the maintenance of catheter cannule potency.

26-03-2002

2626

Ifosfamide

Anticancer- indicated in the treatment of ovarian, breast, testicular carcinoma, hyper nephrone, pancreatic carcinoma and malignant lymphoma.

1978-September

2627

ISMN 60mg Sr + Atenolol 50mg/100mg

For angina pectoris

23.03.07

2628

Memantine hcl tabs.

Each film coated tablet contains; memantine hcl-5mg,10mg

By neurologists only- for the treatment of moderate to severe dementia of Alzheimer's type.

22/07/2004

2629

Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet

For the treatment of patients with diabetic polyneuropathy.

05.01.11

2630

Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + Calcium pantothenate 25mg + Nicotinamide 50mg + Folic acid 0.75mg capsule

For Vitamins and Minerals deficiency states in adult patients.

30.01.08

2631

MI cu 250

Intra-uterine device

1979-May

2632

Ornidazole vaginal tabs.

Each uncoated vaginal tab.contains; ornidazole-500mg

Trichomonal vaginitis & non-specific bacterial vaginitis.

04/07/2001

2633

Orthoclone sterile (OKT-3)

Indicated for acute allograft rejection and in renal transplant patients (Immunosppressant)

1990-October

2634

Paspat injection (finished form for import)

Bronchial asthma, spastic bronchitis, allergic rhinitis, summer conjuctivitis, allergic dermatosis.

27/05/1993

2635

Phenylmethylamine-p-amino benzene sulphonate-15mg, phenylmethylamine Hcl-10 mg

Each tablet contains; phenylmethyl amine-p-amino benzene sulphate-15mg, Phenylmethyl amine hcl- 10mg. Ointment-phenylmethyl amine-p-amino benzene sulphate-1.5% w/w, Phenylmethyl amine hcl-1.5% w/w

Anti-leprosy drug

1969- July

2636

Pidotimod tablet & oral solution

i) Each film coated tablet contains; pidotimod-400mg, 800mg, ii) Each 7ml oral solution contains; pidotimod-400mg, 800mg

For infections of the respiratory system in secondry and primary immunodeficiency with alteration in maturation of T cells in adults only.

15.12.10

2637

Propafenone hydrochloride

Anti arrhythmic agent- Indicated in the treatment of ventricular extra systoles supra ventricular tachycardia etc.

1986-November

2638

rDNA hepatitis B vaccine (10mcg)

10mcg

At a dose of 10mcg up to an age of 19 years approved.

15-09-2000

2639

Salmon calcitonin injection

Each ampoule contains; salmon calcitonin-100 IU/ml, Each vial contains; salmon calcitonin-400 IU/2ml

Hypercalcaemia pain associated with advanced metastic bone cancer, paget's disease, post menopausal osteoporesis.

03/08/1995

2640

Septopal beads and chains

Indicated for the treatment of bone and soft tissue infections.

1985-January

2641

Sildenafil Citrate Injection 0.8mg/ml

For the treatment of pulmonary arterial hypertension (PAH) (WHO Group-1) to improve exercise ability and delay clinical worsening.

05.12.12

2642

Sodium hyaluronate eye drops (0.1%)

Each ml contains; sodium hyaluronate-0.1mg

For the treatment of sensation of ocular dryness and other minor complaints of no pathological significance such as burning and ocular fatigue induced for example by dust, smoke, dry atmosphere, air-conditioning, extended computer screen use or contact leÞ¡

16.01.09

2643

Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength)

For Plaque psoriasis.

24/05/2005

2644

Telmisartan + hydrochlorthiazide tablets

Each uncoated tab contains; telmisartan-40mg,80mg, hydrochlorthiazide-12.5mg

By RMP- for treatment of hypertension as 2nd line therapy.

29-08-2003

2645

Testolactone

1971- November

2646

Vitamin D3 (Cholecalciferol) Orally disintegrating strips 2000 IU (additional Dosage form)

For the treatment of Vitamin D3 deficiency.

01.10.15

2647

Atenolol 25mg/50mg + Indapamide SR 1.5mg

For essential hypertension.

21.05.07

2648

Aminoglutethimide tablets

Anti cancer- In the treatment of metastatic breast cancer.

1985-August

2649

Amoxycillin trihydrate bolus

Each bolus contains; amoxycillin trihydrate-750mg

16/10/1996

2650

Carbenoxolone Sodium

Gastric ulcer

1973-December

2651

Centchroman tab 30mg

Each tablet contains; centchroman-30mg

Used as a oral contraceptive.

1990- November

2652

Clonazepam tabs.

Each tab.contains; clonazepam-0.25mg

Additional indication; petitmal, its variant, akinetic & myoclonic seizures.

05/07/2001

2653

Deltamethrin and Piperonyl butoxide pour-on solution

Each ml of solution contains; deltamethrin 0.50% m/v, piperonyl butoxide-2.0% m/v

Ready to use pour-on for cattle, sheep and goats. For use in cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g, house flies, to kill lice and protection against blackflies. For use in sheep and goats for controllÞ¡

04.11.09

2654

Dexamethasone Intravitreal implant 0.7mg (Additional Indication)

For the treatment of visual impairment due to Diabetic Macular Edema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.

12.10.15

2655

Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit

For iron, folic acid & omega-3-fatty acid deficiency.

08.01.10

2656

Flurbiprofen

50 & 100mg

Non steroid anti inflammatory- Indicated in the treatment of rheumaoid arthritis, Oesteoarthritis and allied disorders.

1979-July

2657

Gabapentin caps

Each capsule contains; gabapentin-300mg,400mg

Epilepsy.

03/08/1995

2658

Gatifloxacin tabs/inj.

Additional indication- for skin & skin structure infection.

2004-July

2659

Gemcitabine Injection 38mg/ml

Ovarian cancer-Gemcitabine injection in combination with cisplatin is indicated for the treatment of patients with advanced ovarian cancer that has replaced at least 6 months after completion of platinum based therapy. Breast Cancer-Gemcitabine injection Þ¡

05.12.12

2660

Glucagon

Hypoglycemic agent- indicated in the treatment of severe hypoglycemic reaction in diabetic patients.

1978-October

2661

Labetolol hydrochloride

Anti hypertensive agent- Indicated in the treatment of all forms of hypertension (except hypertension of pregnancy)

1986-December

2662

Levonorgestrel 0.03mg tablet

For control of fertility

23.03.07

2663

Levosulpiride 75/150/200 mg (add. Strength)

75 mg tablet: For the treatment of gastro intestinal problem like fanatical dyspepsia, nausea, vomiting and diabetic gastroperisis. 150/200mg: For the treatment of depression and schizophrenia in adults.

09.12.14

2664

Mecobalamin 500mcg + Alpha Lipoic Acid 200mg + Benfotiamin 10mg + Pyridoxine 3mg + Biotin 5mg + Folic acid 1.5mg capsule

For Vitamins deficiency states in adult patients.

30.01.08

2665

Methandienone

Each ml contains; methandienone-22.5mg to 27.5mg

1969- September

2666

Midazolam (as maleate) 7.5mg/15mg tablet

For insomnia.

10/05/2006

2667

Moxidectin 1% w/v injection

Moxidectin-1% w/v

In the treatment and control of internal and external parasites in cattle.

16/01/1997

2668

Nadifloxacin 1% cream & bulk

Each gm contains; nadifloxacin-10mg

Acne vulgaris (patients with multiple inflammatory lesion)

28-03-2002

2669

Neutral insulin & Insulin zinc suspension (Human insulin) injection

In the treatment of insulin requiring diabetics by injection or infusion.

1987-September

2670

Nitroglycerin patches (finished formulation)

Each patch contains; nitroglycerin-25mg,50mg

For the treatment of angina pectoris due to coronary artery disease.

03/06/1993

2671

Oxyphenbutazone

0.1gm

Anti-inflammatory, antipyretic.

1961- November

2672

Rofecoxib suspension (oral)

Each 5ml suspension contains; rofecoxib-12.5mg,25mg.

Not to be used in children

25-09-2000

2673

R(-) Ondansetron oral Solution (1mg/5ml)

Each 5ml of oral solution contains; R(-) ondansetron Hcl eq.to R(-) ondansetron-1mg

For Chemotherapy induced nausea and vomiting.

27/05/2005

2674

Sibutramine hcl monohydrate (D.A.R 15-4-97)

Each capsule contains; sibutramine hcl monohydrate-5mg,10mg,15mg

Adjunct therapy for the management of obesity including weight loss and maintenance of weight loss in patients whose BMI is 30kg/m2 or higher.

23-12-1999

2675

Spiramycin inj.

1971- November

2676

Spironolactone IP 25mg + Furosemide IP 40mg Tablet

Additional strength

05.01.11

2677

Vinpocetin injection

Each 1ml inj contains vinpocetin-5mg

For the treatment of psychic & neurological symptoms of cerebral circulatory disturbances (i.e, impaired memory, locomotor disorders etc.)

01/08/2003

2678

2-thymyloxy methyl Glyoxalidine Hcl

0.05%

Vasoconstrictor.

1961- November

2679

Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsule

For the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in adult patients prone to antibiotic associated diarrhoea.

30.01.08

2680

Betamethasone-17-Benzoate

Topical anti-inflammatory steroid.

1973-December

2681

Bicalutamide Tablet 150 mg.(Additional Strength and Indication)

Indicated either alone or as adjuvant to radical Prostatetomy or radiotherapy in Patients with Locally advanced Prostate cancer at High risk for disease Progression.

05.01.11

2682

Bortezomib 2mg/vial (additional pack size)

As approved

28.03.07

2683

Carboprost tromethamine

Syncrhronisation of oestrus and partium in animals and for the treatment of resistant cystic corpus luteum, help in the involution of uterus, in prolonged labour and for the removal of dead foetus in cattle, mares and sheep.

1986-May

2684

Clopamide

20mg

Diuretic- indicated in the treatment of oedema of cardiac hepatic or renal origin and hypertension only.

1979-July

2685

Colistin sulphate + pectin + kaolin

30ml suspension contains; Colistin sulphate-0.154g, pectin-0.196g, kaolin-2.625g

1969- July

2686

Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP 4.00 % + Absolute Alcohol IP 10.00 % v/v Topical Solution

For the Treatment of Acute Lower Back Pain.

21.12.12

2687

Euphorbia prostrata dry extract ethanolic 80% v/v [(35-70):1] cream 1% w/w

Each gram contains; euphorbia prostrata dry extract ethanolic 80% v/v [(35-70):1]- 10mg

For the treatment of 1áµ? and 2áµ? internal haemorrhoids.

17.11.09

2688

Febuxostat 40mg (Additional Strength)

Same As approved

16.01.10

2689

Fenofibrate capsules

Each capsule contains; fenofibrate-200mg (micronized)

For type IIa, IIb, III, IV & V hyper lipidaemias resistant to diet

22-12-1999

2690

Gatifloxacin (200mg) + Ornidazole (500mg) tablet

For diarrhoea of mixed infection in adults.

06/06/2005

2691

Human follicle stimulating Hormone (FSH) and Human leutenising harmone (LH)

Fertility drug- to be supplied to gynaecologists attached to hospitals where facilities exist for screening patients and to private consultations of academic & professional standing.

1978-October

2692

Infliximab injection

For additional indication- in maintenance therapy of Crohn's disease & fistulising Crohn's disease.

15/07/2004

2693

Kiltix collar

Every 10gm of collar contains; propoxur-1000gm, flumethrin-0.225gm

For protection and control of ticks and fleas on dogs.

03/02/1997

2694

Measles vaccine

Each 0.5ml dose contains measles virus (CAM-70 strain) not less than 1000 CCID50

Active immunization against measles.

02/04/2002

2695

Nitrofurantoin dispersible tablets 50 mg (add. Strength/ dosage form)

For the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of E.coli or staphylococcus saprophyticus.

15.12.14

2696

Olmesartan (as Medoxomil) 10mg (addl. Strength)

Anti-hypertensive.

18/05/2006

2697

Rabies veterinary vaccine inactivated

1987-November

2698

Ramipril + candesartan cilexatil tabs

Each uncoated bilayered tab contains; ramipril BP-2.5mg,5mg, candesartan cilexatil eq.to candesartan-8mg

By RMP- for mild to moderate essential hypertension and congestive heart failure (CHF)

2003

2699

Salmeterol + fluticasone propionate inhaler

Each actuation delivers; salmeterol (as xinofoate)-25mcg, fluticasone propionate BP-50mcg,125mcg,250mcg

Bronchial asthma where use of bronchodilator & an inhaled corticosteroid are appropriate.

05/07/2001

2700

Spectinomycin hydrochloride

Anti gonorrheal agent- Indicated in the treatment of acute gonorrheal urethritis & proctitis in male and acute gonorrheal cervicitis & proctitis in females.

1985-September

2701

Stronger neo minophagen-c

Each 2ml contains; monoammonium glycyrrhizinate-4mg (as glycyrrhizin), amino acetic acid-40mg, L.cystein hcl-2mg

Indicated for the management of subacute hepatic failure.

14/12/1995

2702

Ticarcillin + Clavulanate acid inj.

Each vial contains; ticarcillin-3gm, clavulanic acid-100mg

For the treatment of Bacterial infections caused by susceptible organisms in pediatric patients (age > 3 months) subject to all other conditions stipulated in initial permission of the drug remaining same.

30/10/1996

2703

Triptorelin controlled release injection (finished formulation import)

For the treatment of prostate cancer, ovarian cancer, breast cancer, precocious buperty, uterine fibroids, myomes, polycystic ovarian disease and pre-treatment in I.V.F

05/07/1993

2704

Venlafaxine hcl

Each uncoated tablet contains; venlafaxine hcl eq.to venlafaxine-25mg,37.5mg,75mg.

By psychiatrist only, for major depression only.

18-09-2000

2705

Zolpidem Tartarate Orally disintegrating Tablet 5mg/10mg (Additional dosage form)

For insomnia.

12.10.15

2706

Acebrophylline Syrup

Each ml of syrup contains; acebrophylline-10mg

For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.

13.01.09

2707

Amoxycillin

Antibiotic- indicated in the treatment of urinary tract infections, respiratory, genito-urinary, ENT and soft tissue infections.

1978-December

2708

Bambuterol hcl oral solution

Each ml of oral suspension contains; bambuterol hcl-1mg.

By RMP- for bronchospasm in asthma reversible airway disease for children > age of 2 years.

27-09-2000

2709

Bleomycin oil suspension for injection

Anti cancer- Indicated in the treatment of neck & head cancer malignant.

1985-September

2710

Carbazochrome salicylate

Each ml contains; Carbazochrome salicylate eq.to 5mg of adrenochrone monosemicarbazone

1969- July

2711

Chelate amino acid based minerals (finished formulation)

Trace mineral deficiencies.

20/07/1993

2712

Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg)

For HIV infection in adults.

07/06/2005

2713

Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg

For HIV infection

02.04.07

2714

Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system)

For the treatment of macular edema following branch retinal vein occlusion (CRVO).

16.01.10

2715

Dinoprostone vaginal pessary

Each vaginal pessary contains; 10mg dinoprostone in 236 mg hydrogel polymer.

For the initiation & or continuation of envical ripening in patients at or near term in whom there is a medical or obsterical indication for the induction of labour.

01/07/2001

2716

Dobutamine hcl iin 5% dextrose inj.

Each 100ml of inj.contains; dobutamine hcl USP eq.to dobutamine-50mg,100mg,200mg,400mg in 5% dextrose solution

Short term treatment of adult with cardiac decompensation due to depressed contractility resulting either from organic heart disease on from cardiac surgical procedure.

02/04/2002

2717

Etodolac i.m injection 400mg/2ml (Additional dosage form)

For the treatment of post operative orthopaedic pain.

14.12.15

2718

Fluconazole tab

Fluconazole-400mg

Additional strength

2003

2719

Gemcitabine injection

Gemcitabine hcl eq.to gemcitabine-200mg,1000mg

In the management of non small cell lung cancer.

24/01/1996

2720

Influenza vaccine inactivated for equine.

For treatment of Influenza in equine.

1987-November

2721

Iohexol Sterile Sol.

X-ray contrast medium- Indicated in neuroradiology, angiography, urography, arthrography etc.

1986-june

2722

Lamivudine oral solution

25mg/5ml

For the treatment of chronic hepatitis B virus infection.

30-12-1999

2723

Levosalbutamol syrup/tabs.

Tablets-1mg,2mg, syrup-1mg/5ml

For treatment of bronchospasm in patients above 6 years with reasonable obstructive airway disease.

16/07/2004

2724

Methylcobalamin orally disintegrating strips 1500mcg (add. Dosage form/ indication)

For the treatment of peripheral neuropathy and diabetec neuropathy.

17.12.14

2725

Natamycin

Natamycin-2%

Trichonomial agent- indicated in the treatment of vaginal irritation & discharge due to monilial, trichomonial infections.

1979-September

2726

Paracetamol Chewable Tablet 500 mg. (Additional Dosage Form)

Same as approved

05.01.11

2727

Phenelzine dihydrogen sulpha

Anti-depressant.

1961- November

2728

Pregabalin Capsule 25/50/100/200mg (addl. Strength)

Same as approved.

19/05/2006

2729

Stronger neo minophagen-c injection

Same as above

For additional indication of cirrhosis with activity.

05/05/1999

2730

Thiophanate

Anthelmentic

1973-December

2731

Tiaprost trometamol injection (Iliren PGF2 alfa inj.)

Tiaprost trometamol-0.196mg eq.to 150mg of tiaprost

In inducing parturition in cows & buffalos.

19/02/1997

2732

Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules

As 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately.

31.01.08

2733

Triptorelin for injection

Each twin pack contains; (i) Each single dose vial contains; Triptorelin pamoate (Lyophilized) eq. to 3.75mg/11.25mg Triptorelin, (ii) One ampoule of sterile water for injection 2ml

For the treatment of prostate cancer

05.01.12

2734

Buclizine Hcl 25mg Tablet (Additional Indication)

For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness.

16.01.10

2735

Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Efavirenz (600mg)

Each tablet contains; 2 film coated tablets of lamivudine-150mg, zidovudine-300mg & 1 film coated tablet of Efavirenz-600mg

For the treatment of HIV infection in adults.

26/10/2005

2736

Doramectin 1% injectable solution

1% injectable solution

For control of GI round worm, eye worm, screw worms in sheep & swine.

03/10/2000

2737

Fentanyl transdermal patch

Each 10,20,30,40 cm2 patch containing 2.5/5.0/7.5/10mg of fentanyl delivers 25/50/75/100 mcg of fentanyl per hour respectively.

For the management of chronic cancer pain and intractable pain requiring opioid analgesics.

11/01/1999

2738

Glycopyrrolate

ampole 1mL contain 0.2mg of Glycopyrrolate

1979-September

2739

Hamycin

Anti-fungal, anti-biotic.

1961- November

2740

Iron sorbitol citric acid complex

Each ml contains eq.of 50mg of Iron as iron sorbitol citric acid complex.

1969- July

2741

Measles (Edmoustan zagreta strain) mumps and rubella vaccine

1987-December

2742

Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule

For diabetic neuropathy

02.04.07

2743

Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricumÞ¡

For Vitamins and Minerals deficiency states in adult patients.

11.01.11

2744

Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form)

For allergic rhinitis & chronic urticaria.

28.01.08

2745

Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium each

For osteoporosis in postmenopausal women.

01.05.07

2746

Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 10mg tablets

For the treatment of patient with both essential hypertension and hypercholesterolemia.

28.01.08

2747

Nitroglycerine in 5% dextrose inj.

Each 100ml contain; nitroglycerine-10mg,20mg,40mg, dextrose hydrous-5gm

For treatment of perioperative hypertension for control of congestive heart failure in setting of acute MI, angina pectoris in patients who have not responded to sublingual nitroglycerine & beta blockers & for indication of intraoperative hypotension.

02/04/2002

2748

Oxcarbazepine S.R 450mg/900mg Tablet (addl. Strength).

Anti-epileptic.

18/05/2006

2749

Oxyfedrine

Coronary vasodilator

1973-April

2750

Paclitaxel suspension for injection Conc. For nanodispersion 100/300mg (add. Indication)

Management of endometriosis associated pain.

18.12.14

2751

Paracetamol suppositories

Each suppository contains; paracetamol-80mg, 170mg

For symptomatic relief of pain & fever.

10/07/2001

2752

Pimecrolimus 1% cream

Each gm contains; pimecrolimus-10mg

By dermatologists only- for the treatment of mild to moderate atopic dermatitis in patients above 3 months of age and above.

22/07/2004

2753

Prednisolone + Ofloxacin

2003

2754

Purified chick embryo cell (PCEC) tissue culture rabies vaccine

Vaccine- Indicated for treatment after exposure to rabies and for pre-exposure prophylaxis.

1985-November

2755

Sodium hyaluronate 2% Injection

Each ml of pre-filled syringe contains; sodium hyaluronate-20mg

To be used for facial tissue augmentation.

14.01.09

2756

Tacrine hydrochloride caps

Each capsule contains; tacrine hcl-10mg,20mg,30mg,40mg

For the treatment of dementia in patients with Alzheimer's disease of mild to moderate severity.

14/02/1996

2757

Teicoplanin for i.v/i.m infusion

Each vial contains; teicoplanin-100mg.200mg,400mg

Glycopeptide antibiotic-use in serious gram +ve infection, staphylococcal infection in patients sensitive or unresponsive to penicillin and ciphalosporins CAPD related peritonitis, prophylaxis in ortho paedic surgery at risk of gram +ve infections.

19/02/1997

2758

Urovison

Mixture of Sodium salt of and methyl glucanine salt of diatrizoate(40:18)

Contrast media.

1978-December

2759

Zalcitabine film coated tablets (finished formulation)

Each film coated tablet contains; zalcitabine-0.375mg,0.750mg

For the treatment of AIDS

26/07/1993

2760

Abciximab injection

Each 5ml vial contains; abciximab-10mg

02/05/1997

2761

Aceclofenac gel 1.5% along with linseed oil, menthol, Salicylate, Capsaicin

Aceclofenac BP (1.5% w/w) also contains; linseed oil, menthol, methyl salicylate, capscicin.

For the treatment of pain, swelling and inflammation due to musculo skeletal disorder viz., sprains, strains, tensonitis, bursitis, head, neck, shoulder pain, sciatica muscle stiffness, joint pain, backache, lumbago.

14/06/2005

2762

Calcitriol soft gelatin caps (finished formulation)

Each soft gelatin capsule contains; calcitriol-0.5mcg,0.25mcg

For the treatment of metabolic bone disease.

27/08/1993

2763

Calcium citrate malate (bulk)

24.02.09

2764

Cefpodoxime proxetil tabs/dry syrup

i)-Each tab contains; cefpodoxime proxetil-100mg, ii)-cefpodoxime proxetil dry syrup-40mg/5ml

12/03/1996

2765

Ciclesonide rotacaps (200/400mcg)

For Asthma.

19/05/2006

2766

Dequalinium acetate

Bacteriostatic and fungistatic.

1961- November

2767

Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml

For the Relief of Persistent Dry irritating cough in adult patients Only.

17.01.11

2768

Dopamine hcl & 5% dextrose inj.

Each 100ml contains; dopamine hcl-80mg,160mg,320mg, dextrose hydrous-5gm

For the correction of hemodynamic imbalance present in the shock syndrome due to myocardial infarctions, trauma, endotoxic speticemia, open heart surgery, renal failure & chronic cardiac decompensation as in congestive failure.

02/04/2002

2769

Feracrylum tulle 3% w/w gauze dressing

Rayon dressing with water soluble base containg feracrylum-3% w/w.

By RMP- for the management of post operative wounds, cuts, abrasion as haemostatic agent.

29/07/2004

2770

Furaltadone

1973-June

2771

Galanthamine Hydrobromide

Treatment of neuritis & poliomyelitis, infantile cerebral palsies.

1978-December

2772

Guanethidine sulphate

Each ml contains; guanethidine sulphate-10mg

1969- October

2773

Intravenous fat emulsion with medium chain triglycerides

Each 100ml contains; soyabean oil USP-5g or 10g, med.chain triglycerides-5g or 10g, egg lecithin-1.20g or 1.20g, glycerol IP-2.50g or 2.50g, water for inj. Q.s or q.s, energy content-1058 kcal/lit or 1908 kcal/lit, osmolarity-345 Mos mol/lit or 380 Mos moÞ¡

For patients requiring parental nutrition in energy depletion as well as essential fatty acid deficiency states.

11/07/2001

2774

Iron sucrose complex inj. i.v (finished formulation)

All cases of iron deficiency in which rapid and reliable substitution of iron is required.

02/01/1999

2775

Lapatanib tablet 250mg (Additional indication)

Lapatinib in combination with trastuzumab, indicated for the treatment of patients with hormone receptor- negative metastatic breast cancer whose tumours overexpress HER2/neu (ErbB2) and who have progressed onprior trastuzumab therapy in combination with Þ¡

22.12.14

2776

Metronidazole + benzocaine topical gel

Each gm of gel contains; metronidazole (as benzoate)-10mg, benzocaine-200mg

RMP- for treatment of gingivitis

2003-September

2777

Paroxetine hcl

Each tablet contains; paroxetine hcl eq.to paroxetine-10mg,20mg,30mg,40mg

By psychiatrists only- for major depression, obsessive compulsive disorders and panic disorders.

04/10/2000

2778

Pemetrexed Disodium 500mg/100mg Powder for Injection (additional indication)

Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-baseÞ¡

16.01.10

2779

Propofol 10mg + Lignocaem 1mg per ml injection

For induction of anesthesia

04.04.07

2780

Amifostine sterile lyophillised powder for injection

Each vial contains; amifostine-500mg

Indicated as a chemoprotective agent against the serious toxicities associated with intensive regimens of platinum and alkylating agent chemotherapy (on reconstitution each ml will contains 50mg amifostine).

21/03/1996

2781

Cefoperazone sodium inj. Im/iv

Each vial contains; cefoperazone sodium-1g,2g

23/08/1993

2782

Emtricitabine (200mg) capsule

Each capsule contains; emtricitabine-200mg

For HIV infection in adults.

09/06/2005

2783

Ethosuximide

TAB-250MG, Syrup-5ml=0.25g

Anticonvulsant for petitmal epilepsy

1961- December

2784

Ezetimibe 10mg + Fenofibrate 160mg tablet

For combined hypertipidemia

04.04.07

2785

Feracrylum oral capsule

Each capsule contains; feracrylum-100mg

Gastroenterologists-for the treatment of non ulcer dyspepsia associated with H.Pylori

2003-September

2786

Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel

For treatment of hyper pigmentry disorders.

31.01.11

2787

Irinotecan hcl trihydrate solution for i.v infusion

Each 2ml solution contains; irinotecan hcl trihydrate-40mg, Each 5ml solution contains; irinotecan hcl trihydrate-100mg

Anticancer-For the treatment of colo-rectal cancer.

23-05-1997 to 22-05-1999

2788

Itopride 150mg capsule (S.R)

Each capsule containing; Itopride Hcl 150mg (SR)

For gastrointestinal symptoms caused by reduced gastro intestinal motility like feeling of gastric fullness, upper abdominal pain, anorexia, heartburn, nausea & vomiting in non-ulcer dyspepsia or chronic gastritis.

22/05/2006

2789

Leuprolide acetate depot inj.

For additional indicatio; of endometriosis & uterine leiomyomata in women.

17-07-2001

2790

Linezolid IV inj.

Each ml contains; linezolid-2mg, dextrose-5%

Complicated/uncomplicated skin & skin structure infections/community acquired pneumonia.

01/04/2002

2791

Lorazepam

Psychiatric drug.

1973-September

2792

Loteprednol etabonate Nasal spray 0.1%

Loteprednol etabonate- 0.1% w/v

For prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis.

03.02.09

2793

Medroxyprogesterone acetate suspension for injection s.c . Single dose container with 104mg Medroxyprogesterone acetate in 0.65 ml suspension for injection (SAYNA PRESS) (Additional route/ strength/indication)

Indicated for the management of endometriosis-associated pain.

18.12.14

2794

Mycophenolate mofetil caps/tab (finished formulation)

Each cap/tab contains; mycophenolate mofetil-250mg,500mg

For organ rejection in renal transplant etc.

07/02/1999

2795

Oseltamivir 30mg & 45mg Capsules (Additional Strength)

Same as Approved.

28.01.08

2796

Pericyazine

Pericyazine-2.5mg & 10mg

Specialists/hospital

1969- October

2797

Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution

For hygenic and surgical hand disinfection.

18.01.10

2798

Rebamipide tablets

Each film coated tab contains; rebamipide-100mg

By gastroenterologists-for the treatment of gastric intestinal ulcers in adults only.

29/07/2004

2799

Venlafaxine hcl

Each capsule contains; venlafexine hcl eq.to venlafaxine-37.5mg,75mg,150mg as extended release pellets.

Major depression

06/10/2000

2800

5-Fluorouracil

Each 5ml vial contains; 5-Fluorouracil-250mg

Caution

1979-January

2801

Astemizole tablets

Each tablet contains; aztemizole-10mg

Anti allergic- Indicated in the treatment of allergic rhinitis allergic conjunctivitis, chronic urticaria and other allergic conditions.

1988-February

2802

Atenolol 50mg + HCTZ 25mg (addl. Strength)

For hypertension.

03/02/2006

2803

Azelastine nasal spray

Additional indication- for children in the age group of 6-12 years.

08/01/2002

2804

Bethanidine sulphate

10 & 50 mg tablets

Hypertensive drug.

1968- June

2805

Bezafibrate retard tablet

Each film coated retard tab contains; bezafibrate-400mg

02/04/1993

2806

Buprenorphine (old drug) new strength 0.4mg/2mg as sublingual

Each uncoated tablet contains; buprenorphine hcl eq.to 0.4mg, 2mg.

For opioid de-addiction.

10/03/1999

2807

Buserelin acetate injection

Each ml contains; buserelin acetate 4.2mcg eq.to 4mcg of buserelin.

Lueitinising hormone- Indicated in the treatment of infertility of ovarian origin for the induction of ovulation and improvement of conception rate in cows, mares & rabbits

1986-April

2808

Ursodeoxycholic acid tablets 600mg

For the treatment of patients with chronic cholestatic liver disease.

30.01.08

2809

Calcium gluconate + isothipendyl + acetylsalicylic acid + Caffeine

Each dragee contains; calcium gluconate-50mg, isothipendyl hcl-4mg, acetylsalicylic acid-200mg, Caffeine-30mg

1972- June

2810

Ceftaroline Fosamil Injection 600 mg/Vial

Ceftaroline fosamil powder for concentrate for solution for infusion-600mg/vial

"For the treatment of adult (â?¥ 18 years of age) patients with community-acquired pneumonia".

09.05.16

2811

Centbutindole tablets

Each tablet contains; centbutindole-1.5mg

1987-February

2812

Clonazepam tablets

Each tablet contains; clonazepam-0.5mg,1.0mg,2.0mg

In the treatment of petitmal and its variant, akinetic and myoclonic seizures.

25/01/1995

2813

Closantel Injection100mg/ml (for verterinary use)

Each ml contains; closantel-100mg

For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals.

06.02.09

2814

Cyclopenthiazide

1-2 Tablets daily

Non-mercurial oral diuretic & hypotensive.

1962- February

2815

Dabrafenib capsule 50mg/75mg

Each hard gelatin capsule contains; Dabrafenib Mesylate eq. To 50mg Dabrafenib, Each hard gelatin capsule contains; Dabrafenib Mesylate eq. To 75mg Dabrafenib

As a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test. In combination with Trametinib for the treatment of patients with unresectable or metastatic melanoma witÞ¡

18.01.17

2816

Desloratadine + Pseudoephedrine (SR) tablets

Each tablet contains; desloratadine-2.5mg,5mg, pseudoephedrine SR-120mg,180mg

2004

2817

Dichlorphenamide

50mg tabs

Carbonic anhydrase inhibitor.

1964- January

2818

Diclofenac potassium sugar coated tabs

Each sugar coated tablet contains; diclofenac potassium-50mg

18/03/1994

2819

Diethylamine Salicylate

Diethylamine Salicylate-10% w/w

For external use only

1978-March

2820

Difluprednate Opthalmic Emulsion 0.05% w/v

Each ml contains; difluprednate-0.5mg

For the treatment of inflammation and painÂ associated with ocular surgery.Â

01.04.10

2821

Disophenol

Each c.c contains; disophenol-45mg

Treatment of hook worm in dogs and cats.

1970- April

2822

dl-naorgestrel + Ethinyl oestradiol

Each tablet contains; dl-naorgestrel-0.5mg, Ethinyl oestradiol-0.03mg

Oral contraceptive

1975- April

2823

Erythromycin Propionate + Benzyl alcohol + Lidocane

Each mL contains; Erythromycin Propionate eq.to 50mg of Erythromycin base, Benzyl alcohol-0.02mL, Lidocane-0.02gm

1974-March

2824

Estriol Succinate

Each tablet contains; Estriol Succinate-2mg

Estrogen- indicated in the treatment of local and general complaints arising from diminished estrogen production after the menopause and after surgical removal of ovary.

1980-March

2825

Fluticasone propionate cream/ointment

Fluticasone propionate cream-0.05%, fluticasone propionate ointment-0.005%, fluticasone propionate nasal spray-0.05%(12-5-2000)

Inflammatory and pruritic manifestation of corticosteroid responsive eczema dermatitis.

18/03/1996

2826

Halobetasol 0.05% + Clotrimazole 1.0% cream

For the treatment of steroid responsive fungal infections including eczema and psoriasis.

04.01.08

2827

Insulin glargine inj.

Each vial/cartridge contains lantus insulin glargine soln for inj-100 IU/ml

Insulin dependent diabetes mellitus type-I & type-II cases.

07/01/2003

2828

Iron polymaltose

2ml=100mg Fe

Antianaemia-iron therapy.

1963- April

2829

isoniazid + Ethambutol + Vitamin B6

Each tablet contains; isoniazid-300mg, ethambutol-800mg, vitamin B6-10mg

Anti-TB fide

21-01-2000

2830

KFD Vaccine (Kyasanur forest disease)

1989-March

2831

Metoprolol injection

Each ml contains; metoprolol tartrate-1mg

1985-August

2832

Metoprolol tartrate

Antihypertensive agent- Indicated in the treatment of hypertension.

1982-March

2833

Mucotrol Concentrated Oral Gel Wafer.

For the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiotherapy). Þ¡

07.03.12

2834

Multi organ preservative solution

i)-Component A (1000ml,2000ml,4000ml) Each 100ml contains; glucose anhydrous-3.57gm, water for inj.q.s, ii)-Component B (20ml,40ml,80ml) supplementary electrolyte solution pot.dihydrogen PO4-10.76g, pot.monohydrogen PO4-37.74g, Kcl-5.7g, Na2CO3 IP-4.3g, wÞ¡

31-01-2001

2835

Neomycine Sulphate + Polymyxin B Sulphate + Zinc Bacitracin + Propellent

Each Aerosol pack of 210gm contains; Neomycine Sulphate-910mg, Polymyxin B Sulphate-300,000 Units, Zinc Bacitracin-75000 Units, Propellent to make-210gm

1977-March

2836

Niclosamide

Anthelmintic against tape worm

1965- February

2837

O-ethoxybenzamide

200mg to 500mg

Alagesic, antiphlogistic, antipyretic.

1961- February

2838

Zonisamide capsule 25/50mg (addl. Strength)

Same as approved.

25/05/2006

2839

Ofloxacin

Each tablet contains; ofloxacin-100mg,200mg,400mg

Antibacterial agents- For the treatment of respiratory tract infection, UTI, gynaecological infection, skin or soft tissue infection.

1990- February

2840

Ofloxacin (200mg) + Ornidazole (500mg)

Each film coated tablet contains; ofloxacin USP-200mg, ornidazole-500mg

By RMP- For treatment of diarrhea of mixed infection in adult only.

19.01.2005

2841

Omeprazole

Each capsule contains; 20mg(as enteric coated granules),10mg(31-3-94)

Short term treatment of duodenal ulcer, gastric ulcer, reflux oesophagitis, management of zollinger ellison syndrome.

1991- April

2842

Oxazepam

10 mg tabs

Tranquilizer

1967-March

2843

Oxazepam

10 mg tabs

Tranquiliser

1966- April

2844

Pasireotide solution for injection 0.3mg/ml, 06mg/ml and 0.9mg/ml

Each ml contains 0.3mg pasireotide (as diaspartate), Each ml contains 0.6mg pasireotide (as diaspartae), Each ml contains 0.9mg pasireotide (as diaspartae)

"For the treatment of adult patients with Cushingâ??s Disease for whom Pituitary surgery is not an option or has not been curative".

18.03.15

2845

Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength)

As approved

23.01.07

2846

Pyrantel tartrate

In the treatment if ingestation with G.I round worm in sheep, cattle & swine (Broad spectrum anthelmintic)

1969- April

2847

Rifampicin + Isoniazid

Rifampicin-300mg+INH-200mg, Rifampicin-450mg+INH-300mg, Rifampicin-600mg+INH-300mg

1983-June

2848

Roflumilast Tab 500 mcg

Each film coated tablet contains; roflumilast-500mcg

For the "maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilÞ¡

17.07.14

2849

Roxithromycin

Each film coated tablet contains; roxithromycin-150mg, 300mg(20-8-93, Roussel), roxithromycin kid tab-50mg (30-3-94-Alembic), roxithromycin dispersible tab-50mg(Torrent), roxithromycin dry syrup-50mg/5ml (26-4-96 Alembic)

Antibiotic- Sensitive strain infections of ENT, bronchopulmonary tract infection, genital except for gonococcal infections, prophylaxis of meningococcal meningitis in exposed subjects.

27/03/1992

2850

Saccharomyces Cerevisiae

Each capsule contains; dried yeast powder-250 mg, saccharamyces cervisiae containing not less than 10 million living cells.

1971- January

2851

Salbutamol sulphate

Each tablet contains; Salbutamal sulphate-4mg

1973-February

2852

Sodium Cromoglycate

1976-May

2853

Sodium picosulphate

i)-Each uncoated tab contains; sodium picosulphate-5mg,10mg ii)-Each 5ml syrup contains; sodium picosulphate-5mg

Constipation bowel clearance before labour or surgery, radiological examination.

11/02/1997

2854

Tamoxifen citrate

Each capsule contains; Tamoxifen citrate eq to 10mg of tamoxifen citrate

1981-April

2855

Tinidazole + Diloxanide furoate

Each tablet contains; tinidazole-150mg, diloxanide furoate-250mg

1984-September

2856

Tioconazole Vaginal Gel 65mg per gm

Each gm contains; tioconazole-65mg

For the local treatment of vulvo vaginal candidiasis in adult patients.

22.03.11

2857

Tolfenamic acid caps

Each capsule contains; tolfenamic acid-200mg

Rheumatoid arthritis, osteo arthritis, ankylosing spondylitis and related conditions associated with pain.

04/03/1998

2858

Trimethoxysilyl Quaternary Ammonium Chloride 0.40% hand protectant and sanitizer

Trimethoxysilyl Quaternary Ammonium Chloride-0.40%

Hand Protectant and Sanitizer for external use. Effective upto 24 hours.

11.06.13

2859

Aliskiren 150/160mg + Valsartan 300/320mg tablets

For the treatment of hypertension.

19.01.10

2860

Calcium succinate & Iron edetate sodium

1969- October

2861

Didanosine delayed release caps.

Each delayed release cap.contains; didanosine (as enteric coated beadlets)-125mg,200mg,250mg,400mg

For HIV infections when anti retroviral therapy is warranted.

24-07-2001

2862

Empty Hydroxy Propyl Methyl Celulose Capsules

11.01.11

2863

Eplerenone Tablet (25mg/50mg)

Each film coated tablet contains; eplerenone-25mg, 50mg

For the treatment of mild to moderate hypertension in adults.

09/06/2005

2864

Fondaparinax Sodium injection (Additional Indication)

Treatment of acute coronary syndrome (ACS) with and without ST-segment elevation.

28.01.08

2865

Fusafungine

Old drug with new pump system

26/03/1996

2866

Haemocoagulase gel (topical)

Each gm of gel contains; Haemocoagulase isolated from Bothrops Atrox or Bothrops jararaca 1.0 CU, Chlorhexidine gluconate solution (0.1w/w)

For the topical treatment of localised capillary haemorrhage & wound healing.

22.11.2004

2867

Kit for preparation of Medronate (Sn) MTC injectable

Each vial contains; (on reconstitution) medronic acid-10mg, stannous chloride, 2H2O-1mg

Diagnosis and study of primarily cancer metastatic bone lesion and other bone diseases. Paget's disease osteomylitis fractures.

23-02-1999

2868

Meloxicam inj.

Each vial contains; meloxicam-5mg/ml

Painful inflammatory conditions including arthritis in animals as well as pyrexia.

02/04/2002

2869

Methylprednisolone Acrponate topical solution 0.1%

Each ml contains; methylprednisolone aceponate-1mg

For the treatment of atopic dermatitis (eczema) inflammatory and allergic skin reaction.

09.04.07

2870

Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg

For hypertension.

24/05/2006

2871

Paracetamol Fast Release Tablet 500mg (Additional Dosage Form)

Same as approved

10.02.11

2872

Pimaricin

Oint-20mg/gm, Vag tab-50mg

Anti fungal antibiotic for "Streptomyces natalensis".

1961- December

2873

Pioglitazone hcl

Each uncoated tablet contains; pioglitazone hcl eq.to 15mg, 30mg, 45mg of pioglitazone.

As an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes (NIDDM)

17-10-2000

2874

Rosuvastatin calcium

2003

2875

Sorbisteri capsules (finish formulation)

Each soft gelatin capsule contains; calcium loaded sulfonated polystyrene cation exchange resin 0.5gm (eq.to 1.8mEq Ca++), cross linked with 8% divinul benzene.

13/09/1993

2876

Spenglersan colloid G

Immunomodulator

02/06/1997

2877

Surgical sealant

Consists of following components in individual pouches; i) One pouch for the premixed polyethylene glycol powder in syringe. Ii) One pouch for the pre-assembled liquid (solution) syringe containing dilute hydrogen chloride solution and a phosphate/sodium Þ¡

To be indicated for use in sealing suture lines along arterial and venous reconstructions.

31.03.09

2878

Azelastine eye drops

0.5mg/ml

05/05/2000

2879

Camostat Mesylate tablets 100mg

For remission of acute symptoms of chronic pancreatitis and post-operative reflux esophagitis.

29.01.08

2880

Citicoline (750mg) tablet (additional strength), syrup 500mg/5ml (new dosage Form) (not For children)

As approved

10.04.07

2881

Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm

For bowel cleansing prior to colonoscopy in adult patients only.

11.02.11

2882

Famciclovir tab & bulk

Each film coated tab contains; famciclovir-125mg,250mg,500mg,750mg

Herpes zoster in immuno competents & immuno compromised patients.

11/04/2002

2883

Filgrastism injection (finished formulation)

1.6ml contains; filgrastin-48MU, 1ml contains; filgrastim-30MU

30/09/1993

2884

Gemcitabine for additional indication

Additional indication- gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian cancer more than 6 months after latnum based first line therapies.

26/07/2004

2885

Goserelin acetate injection

Goserelin acetate eq.to 3.6mg of gesoserlin

In the treatment of prostate cancer, breast cancer, endometriosis.

24/04/1996

2886

Hepatitis-B Vaccine (recombinant)

Each vial contains; Hepatitis B surface antigen (HBsAg)-20mcg/ml, 100mcg/100ml, 10mcg/0.5ml

For active immunization against Hepatitis-B

31-10-2000

2887

Indacaterol (as Maleate) capsules 150mcg/300mcg

Each capsule contains; indacaterol 150mcg, 300mcg (as Indacaterol Maleate)

For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).

28.02.2014

2888

Kanamycin sulphate

1 g daily

Antibiotic for cases resistant to other antibiotic, urinary tracks staphylococcus infections.

1961- December

2889

Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet

For production cough

24/05/2006

2890

Lidocaine patch 5%

Each adhesive patch contains; lidocaine-700mg in an aqueous base (50mg per gram adhesive)

For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

31.03.09

2891

Losartan + ramipril tabs

Each tablet contains; losartan potassium-50mg, ramipril BP-2.5mg,5mg

RMP- mild to moderate hypertension.

10/09/2003

2892

Mebrophen hydramine

Mebrophen hydramine-25mg

1969- December

2893

Piroxicam 20mg tab & Paracetamol 500mg tab combikit

For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short tÞ¡

19.01.10

2894

Prazosin mesylate

Mild to moderate hypertension only

11/03/1999

2895

Stavudine + lamivudine + neviramine tabs.

Each tab.contains; stavudine-30mg,40mg, lamivudine-150mg, neviramine-200mg

HIV infections in adult patients. One patients have been stabilized on the maintenane regimen of neviramine 200mg B.D & have demonstrated adequate tolerability to neviramine.

26-07-2001

2896

Strontium Ranelate Granules (2gm/Sachet)

Each sachet contains; stronium ranelate (granule) anhydrus-2gm

For the treatment of osteoporosis in post-menopausal women.

14/06/2005

2897

Apramycin sulphate

50gm in each 100gm.

Bacterial enteritis cellibacllosis, salmonellosis in poultry.

22/07/1997

2898

Beriplast (fibrin adhesive glue)

Tissue adhesion, suture support, haemostasis, wound care, sealing of body cavities and subarachnoid space only.

19/06/1996

2899

Depo-provera inj. (finished formulation)

18/11/1993

2900

Diclofenac sod.+ gentamicin SO4

Each ml contains; diclofenac sod.-1mg, gentamicin SO4-3mg

Inflammation of the anterior segment of the eye when there is a risk of bacterial ocular infection.

26-03-1999

2901

Emollient cream

Composion: sod.pyrrolidone carboxylic acid-2.5%w/w, sod.lactate soln eq.to sod.lactate-2.5%w/w, vit.E IP-1%w/w, Olive oil BP-3%w/w

Dry scaly conditions associated with atopy, hyperkeratosic & other eczemas.

15-04-2002

2902

Ertapenem For injection (1gm/vial)

Each vial contains; ertapenem sodium eq.to ertapenem-1gm

For the treatment of patient with moderate to severe bacterial infection viz: complicated intra-abdominal infections, skin and skin structure infection, community acquire pneumonia, complicated UTI, acute pelvic infections, post surgical gynecologic infecÞ¡

11.04.07

2903

FDC of butaphosphan + methyl hydroxybenzoate + cyanocobolamine powder

Each one kg of the formulation contains; butaphosphan-100gm, methyl hydroxybenzoate-1gm, cyanocobolamin-50gm

As vitamin and phosphorous supplement for livestock shrimp and fish.

20.03.09

2904

Feracrylum spray

Each spray contains; feracrylum-1% & 3%

Management of post-operative wounds, cuts, abrasion as an haemostatic agent.

24-07-2001

2905

Ferric Carboxymaltose equivalent to elemental Ironâ?¦50mg/ml Injection

For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used.

11.02.11

2906

Fexofenadine hcl

Each tablet contains; fexofenadine hcl-60mg, 30mg

By RMP- 30mg for relief of seasonal allergic rhinitis in children (6-12yrs), 60mg tab for relief of chronic idiopathic urticaria in 12yrs age and older chldren.

01/11/2000

2907

Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe

For intradermal implantation and facial soft tissue augmentation.

30.01.08

2908

Ibandronic Acid Tablet (150mg) & Inj. (1mg/ml)addl. Strength

Addition indication; Tablet- for the treatment of prevention of osteoporosis in post menopausal women. Infusion- for metastatic bone diseases due to breast cancer subj to other condition of previous permission No. 6519/06 dt 30-3-2006 same.

29/05/2006

2909

Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet

For pediatric patients with HIV infection.

14/06/2005

2910

Levofloxacin tabs

Levofloxacin-750mg

For the treatment of complicated skin and skin structure infections only

20-06-2003

2911

Orciprenaline sulphate

Orciprenaline sulphate-10mg

1969- December

2912

Rabeprazole + Mosapride SR

Rabeprazole-20mg, mosapride-15mg

27/07/2004

2913

Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dlalpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100mÞ¡

Total parenteral nutrition following major abdominal, major thoracic or major urological surgery.

19.01.10

2914

Amifostine

NOC issued for additional indication; for use in association with standard fractionated radiation therapy to protec aganst acute and late xeroxtomia in hand and neck cancer.

06/11/2000

2915

Amifostine sterile lyophillized powder for inj.

Each vial contains; amifostine sterie lyophilised powder for inj. 300mg (on reconstitution each ml will contain 50mg of amifostine)

Additional strength.

23-07-2001

2916

Atropine sulphate + hyoscyamine sulphate + scopolamine hcl + phenobaribotol

Atropine sulphate-0.06mg,hyoscyamine sulphate-0.30mg, scopolamine hcl-0.035mg, phenobaribotol-64.8mg

1969- December

2917

Deflazacort Tablet 18mg (Additional Strength)

Same as approved

30.01.10

2918

Diclofenac diethylamine transdermal patch

Each 50 sq.cm and 75 sq.cm transdermal patch contains; diclofenac diethylamine-100mg

By RMP only- for the treatment of mild to moderate pain due to osteoarthritis or soft tissue injury.

2004-August

2919

Formoterol fumerate & budesonide inhaler

Each actuation delivers; formoterol fumerate-6mcg, budesonide BP-400mcg

Asthma where use of combination of inhaled regular corticosteroid & long acting beta-agonist is apropriate.

23-04-2002

2920

Ioversol injection (finished formulation)

160,240,300,320,350

Contrast medium

29/12/1993

2921

Ketorolac tromethamine Gel

Each mg of gel contains; ketorolac tromethamine USP- 20mg

For the treatment of muscle, joint and post-traumatic stress.

01.04.09

2922

Letrozole 2.5mg tablet (for additional indication)

For induction of ovulation in anovulatory infertility (additional indication).

10.04.07

2923

Levofloxaxin inj.

Levofloxacin-750mg

17-09-2003

2924

MMR Vaccine

In each 0.5ml dose contains; Schwarz measles (NLT)103.0 CCID50, RIT 3485 mumps (NLT)103.7 CCID50, Wister RA 27/3 rubella (NLT)103.0CCID50

26-03-1999

2925

Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet

Each tablet contains; nitazoxanide-500mg, ofloxacin-200mg

For the treatment of enterocolitis/urogenital infection and other susceptible infections in in adult patients only.

01/07/2005

2926

Rocuronium bromide inj.

Rocuronium bromide inj.-50mg/5ml, 100mg/10ml

As an adjuvant to general anaesthesia to facilitate endotracheal incubation to provide skeletal muscle relaxation during surgery.

18/06/1996

2927

Saquinavir caps

In the treatment of advanced HIV infection

26-08-1997 to 26-08-1997

2928

Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml.

For the treatment of patients with chronic cholestatic liver disease.

11.02.11

2929

Baclofen ER Capsule 10 mg/50 mg. (Additional Strength)

Same as approved

17.02.11

2930

Cefetamet pivoxil oral suspension

Each (5ml) contains; cefetamet pivoxil hcl-250mg

By RMP- for the treatment of infection caused by susceptible microorganism found in the otitis media, sinusitis, pharyngo tonsilitis, acute exacerbation of chronic bronchitis of bacterial origin, pneumonea, complicated/uncomplicated UTI and acute gonococcÞ¡

2004-August

2931

Dalteparin Sodium Injection (Additional Indication)

For the extended treatment of symptomatic venous thromboembolism (VTE) proximal deep thrombosis (DVT) and/or pulmonary embolism (PE), to reduce the recurrence of VTE in patients with cancer.

30.01.08

2932

Diphenoxylate Hcl.-2.5mg + Atropine sulphate-0.025mg

Each tablet contains; Diphenoxylate Hcl.-2.5mg + Atropine sulphate-0.025mg

1969- June

2933

Frusemide + potassium chloride CR tablet

Each CR tablet contains; frusemide-40mg,20mg(23-9-93), pot.chloride-600mg,300mg(23-9-93)

26/02/1993

2934

Ibopamine hcl eye drops (bulk+formulation)

Each ml of eye drop contains; ibopamine hcl eq.to ibopamine-2mg

Ophthalmologists- as mydriatic agents in diagnostic ophthalmology.

03/10/2003

2935

Ketoprofen transdermal patches

Each patch contains; ketoprofen-30mg

For the relief of musculoskeletal pain & inflammation.

17-05-1999

2936

Midazolam Maleate Bulk

Anesthetic.

05/07/2005

2937

Perflutren liquid microsphere injectable suspension

For diagnostic use.

31/05/2006

2938

Pregabalin SR Tablet 75mg (Additional Strength)

Same as approved

30.01.10

2939

Quetiapine SR Tablets 50mg (additional strength)

As approved

10.04.07

2940

Recombinant human Erythropoeitin inj.

Each vial contains; rHuman erythropoeitin-2000IU, 4000IU

For hospitals/institutions & prescription of cancer specialist for anemia due to chronic renal failure, anemia associated with cancer & cancer chemotherapy, HIV infected patients on zidovudine, adult surgery patients in autologus pre-donation program and Þ¡

08/11/2000

2941

Ritonavir caps

Each capsule contains; ritonavir-100mg

In the treatment of advanced HIV infection-by qualified physician not below the age of 12 years to administer.

08-09-1997 to 08-09-1999

2942

Sevoflurane inhalation

For induction and maintenance of general anaesthesia in all procedures and patients types.

09/07/1996

2943

Sparfloxacin

Each 5ml contains; sparfloxacin-0.3% w/v

Bacterial conjunctivitis, bacterial corneal infections like keratitis, kerato-conjunctivitis and corneal ulcer caused by suscepible micro organism.

09/08/2001

2944

Sucrolase USP (Bulk)

12.05.09

2945

Tamsulosin hcl MR cap.

each capsule contains; tamsulosin hcl (as MR pellets)-400mcg,200mcg

Signs & symptoms of benign prostatic hyperplasia.

04/04/2002

2946

Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream

For the topical treatment of bacterial and fungal infections.

30.01.08

2947

Calcium Polycarbophil (500mg) Tablet

For additional indication; for 500mg oral tablets

i) for relieving diarrhoea, ii) for improving irritable bowel syndrome

13/07/2005

2948

Cinnarizine 20mg + Dimenhydrinate 40mg tablets

For the treatment of vertigo

03.02.10

2949

Ciprofloxacin ER Caps.

Each capsule contains; ciprofloxacin-500mg, 1000mg

By RMP- In treatment of respiratory tract infection, sinusitis, urinary tract infection, skin & soft tissue infection, gynaecological infection.

16-08-2001

2950

Citicholine tablets & injection

Each film coated tablet contains; citicholine sod.eq.to citicholine-500mg. Each ml of injection contains; citicholine sod.eq.to citicholine-250mg,500mg.

Neurologists & specialists- tablets: for treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerating damages and chronic cerebral vascular injuries in senile demÞ¡

23/08/2004

2951

Cyclosporin Eye drops (0.1%) (addl. Strength)

For Ophthalmic use.

02/06/2006

2952

Dexketoprofen Trometamol ER Tablet 50mg (Additional Strength)

Same as approved

21.02.11

2953

Gliclazide modified release tabs.

Each u.c, scored M.R tabs gliclazide-30mg

By RMP- in treatment of NIDDM (type-II) in association with dietary measures in adult only.

09/11/2000

2954

Itraconazole inj.

Each ml inj.contains; itraconazole-10mg

Emperic therapy of febrile neutroprnic patients with suspected fungal infections.

29-04-2002

2955

Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength)

As approved

10.04.07

2956

Nimesulide suppository

Each suppository contains; nimesulide-50mg,100mg, 200mg(22-3-2000)

17-05-1999

2957

Perindopril arginine tablet

Each film coated tablet contains; perindopril arginine-2.5mg, 5mg, 10mg

For the treatment of arterial hypertension, congestive heart failure and coronary artery disease.

19.05.09

2958

Polysachharide pneumococcal vaccine (pneumo 23)

Marketed for the prevention of pneumococcal pneumonia and pneumococcal systemic infections caused by the serotypes included in the vaccine.

09/07/1996

2959

Riluzole tablets

In the treatment of patients with amyotrophic later sclerosis (motor neurone disease).

17-10-1997 to 17-10-1999

2960

Valdecoxib tabs

Each tablet contains; valdecoxib-40mg

Additional strength-for primary dysmenorrhoea in adult only.

2003-September

2961

Nepafenac (Bulk)

08.06.09

2962

Artemether injection

Each ampoule contains; artemether-80mg, Each cap contains; artemether-40mg

Promoted for use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only.

02/08/1996

2963

Atorvastatin + Ezetimibe tabs.

Each tablet contains; atorvastatin-10mg,20mg, ezetimibe-10mg

13/08/2004

2964

Combi pack of interferon alpha-2b inj. Multidose pen & ribavirin cap

Each combi pack contains; ribavirin caps-200mg each (70 caps), interferon alpha-2b inj.multidose pen-18MIU in 1.2 ml

28-08-2001

2965

Exenatide injection (Each 2ml vial contains; Exenatide 5mcg/10mcg per 0.2ml ) (Additional Strength)

For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who have not achieved adequate glycemic control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas.

30.01.08

2966

FDC of Papain + Urea Ointment

Each gm of ointment contains; papain USP â?¥ 521700 units, urea USP=100mg

For debridement of necrotic tissues and liquifaction of pus in acute & chronic lesions viz., decubitus vericose, diabetic ulcers, burns & postoperative wounds etc.

15/07/2005

2967

Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops

For Ophthalmic use.

02/06/2006

2968

Gatifloxacin Eye drop 5 mg/ml

For the treatment of bacterial conjunctivitis caused by susceptible strains.

21.02.11

2969

Levovist

Levovist 4gm and 2.5gm granules per 20ml vial, 1gm granules contains; galactose-999mg, palmetic acid-1mg

Contrast media-One and two dimensional doppler senographic blood flow in aging in patients when there is an insufficient dopler. signal intensity and for B mode contrast echo-cardiography.

28-11-1997 to 28-11-1999

2970

Lipid Based Amphotericin-B Gel 0.1%

Indicated in the treatment of cutaneous and mucocutaneous mycotic infections caused by candida (Monilia) species.

05.02.10

2971

Milrinone lactate inj

Each ml of solution contains; milrinone (as lactate)-1mg

In short term treatment of severe congestive heart failure irresponsive in to conventional maintenance therapy and in acute heart failure including low output state following surgery.

17-05-1999

2972

Nadifloxacin (1%) + clobetasol (0.05%)

Each gm of cream/gel contains; nadifloxacin-10mg, clobetasol propionate-500mcg

By Dermatologists- for the treatment of skin associated with bacterial infection including contact dermatitis, seborrhoea dermatitis an infective eczema.

06/10/2003

2973

Nateglinide tabs/bulk

Each film coated tab contains; nateglinide-60mg,120mg

Type-II diabetes (NIDDM) where hyperglycemia is not be adequately controlled by diet and physical exercise and who have not been chronically treated with other anti diabetic.

01/05/2002

2974

Orlistat capsules

Each capsule contains; orlistat-60mg

For obesity management including weight loss and weight maintenance when used in conjunction with a reduced calorie diet in obese patients with initial BMI â?¥ 30kg/m2 or â?¥ 27kg/m2 in presence of other risk factor (e.g, hypertension, diabetes, dyslipidemia)Þ¡

01.06.09

2975

Salmeterol xinafoate + fluticasone propionate

Each single actuation delivers; salmeterol xinafoate eq.to salmeterol-25mcg, fluticasone propionate-50mcg, 125mcg, 250mcg

By RMP- for regular treatment of bronchial asthma where the use of a bronchodilator and an inhaled cortocosteroid are appropriate.

09/11/2000

2976

Sunitinib Maleate Capsules 12.5mg/25mg/50mg

Each hard gelatin capsule contains; sunatinib malate-12.5mg, 25mg, 50mg

For the treatment of G.I. Stromal tumor after disease progression on or intolerance to imatinib mesylate and advanced renal cell carcinoma.

11.04.07

2977

Abacavir sulphate + zidovudine+lamivudine tabs

Each tab contains; lamivudine-150mg, zidovudine-300mg, abacavir(as sulphate)-300mg

By RMP- alone or in combination with other antiretroviral agents for treatment of HIV-1 infection.

03/10/2003

2978

Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg.

For hypertension.

05/06/2006

2979

Basiliximab inj.

For the prophylaxis of acute organ rejection in de-novo transplantation & is to be used concomitantly with cyclosporin for microemulsion & corticosteroid immuno suppression.

28-05-1999

2980

Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml)

Antibiotic

20.04.07

2981

Coumaphos + propxur + sulphanilamide powder

Composition: coumaphos-3%, propoxur-2%, sulphanilamide-5%

For use as larvicidal bacteriostatic wound dressing in cattle, sheep, pigs & horses.

23-04-2002

2982

Diclofenac Sodium 50mg + Paracetamol 500mg tablets

For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

30.01.08

2983

Fluticasone propionate nebuliser solution

Each 2ml respules contains; fluticasone propionate B.P-0.5mg, 2.0mg

By RMP- for the prophylactic management of severe chronic bronchial asthma in patients requiring high dose inhaled or oral corticosteroid therapy.

09/11/2000

2984

Formoterol fumarate + budesonide rotacaps (as dry powder inhaler)

Each cap.contains; formoterol fumerate-6mcg, budesonide B.P-100mcg,200mcg

Asthma where use of combination of inhaled regular corticosteroid & long acting beta agonist is appropriate.

17-08-2001

2985

Influenza vaccine inactivated (vaxigrip)

Prophylaxis against influenza.

13/08/1996

2986

Injection monocomponent insulin lispro (r DNA)

Each 10ml vial contains; monocomponent insulin lispro-40 Iu/ml (rDNA origin)

01/12/1997

2987

Moxifloxacin ophthalmic solution 0.5%

Each ml of ophthalmic solution contains; moxifloxacin hcl eq.to moxifloxacin base-5mg

By ophthalmologists only- for the treatment of bacterial conjunctivitis caused by susceptible organism.

27/08/2004

2988

Paclitaxel Injection 30mg/100 mg/300mg (additional Indication)

Advanced squmous cell carcinoma of Head and Neck SCCHN: 1. Diagnosed but unrectable locally advanced SCCHN 2. Recurrent SCCHN, if surgery or radiation is not feasible. 3. Palliative treatment of metastatic SCCHN

24.02.11

2989

Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength)

Same as approved

06.02.10

2990

Testosterone Gel1%.

Testerone USP-1% w/w gel base.

For replacement therapy in male for conditions associated with deficiency or absence of endogenous testosterone viz. Primary hypogonadism & hypogonadotropic hypogonadism.

12/07/2005

2991

Amino acid 5% inj.

Each 100ml contains; l-isoleucine-0.353g, l-leucine-0.500g, l-valine-0.380g, l-lysine-0.550g, l-methionine-0.120g, l-phenylalanine-0.210g, l-threonine-0.125g, l-tryptophan-0.100g, l-arginine-0.420g, l-histidine-0.190g, l-alanine-0.400g, l-aspartic acid-0.Þ¡

For prophylaxis & therapeutic treatment of protein depletion in children where oral/enternal nutrition is impossible/impracticable.

23-04-2002

2992

Aprepitant 40mg capsules (additional strength)

Prevention of post-operative nausea & vomiting (additional indication).

24.04.07

2993

Didanosine chewable tabs

Each tablet contains; didanosine-25mg, 50mg, 100mg

By RMP- HIV infection when anti-retroviral therapy is wanted.

15-11-2000

2994

Erlotinib Hydrochloride (25mg/100mg /150mg Tablet)

Each film coate tablet contains; erlotinib Hcl eq.to erlotinib-25mg, 100mg, 150mg

For the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of atleast one prior chemotherapy regimen.

21/07/2005

2995

Gabapentin SR 600mg tablets

As adjunctive therapy in the treatment of partial seizures of epilepsy.

30.01.08

2996

Glipizide GITs tabs (gastro intestinal therapeutic system)

Each tab contains; glipizide-5mg,10mg

Non insulin dependent diabetes mellitus (NIDDM type-II)

21/08/1996

2997

Ketoprofen Plaster ( Size - 7cm x 10 cm)

For the Relief of Musculoskeletal pain and Inflammation.

09.03.11

2998

Leuprolide acetate sepot for inj.

Each vial contains; leuprolide acetate-3.75mg

Indicated for the treatment of prostatic cancer only.

10-12-1997 to 10-12-1999

2999

Methadone syrup and tablets

i) Each ml of syrup contains; methadone hydrochloride IP-5mg,10mg, ii) Each tablet contains; methadone hydrochloride IP-5mg,10mg,20mg,40mg

For the treatment of opioid dependence and for maintainence treatment for opioid dependence.

01.06.09

3000

Miglitol tablets

Each film coated tablet contains; miglitol-25mg,50mg,100mg

By RMP only- as an adjunct to diet to improve glycemic control in patients with NIDDM whose hyperglycemia cannot be managed with diet alone.

2004-August

3001

Milnacipran Hcl 12.5mg (Addl. Strength)

Same as approved

06.02.10

3002

Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream

For dermatoses.

06/06/2006

3003

Piperacillin + Tazobactum i.v inj.

Each vial contains piperacillin sod.eq.to piperacillin-4gm,2gm+Tazobactum sod.eq.to tazobactum-500mg,250mg

In the treatment of LRTI/UTI/Intra abdominal infections, skin and skin structure infections, bacterial septicemic polymicrobic infections.

13-08-1999

3004

Sumatriptan nasal spray

Each actuation delivers; sumatriptan-5mg,20mg

Acute migraine attacks with or without aura only when there is a clear diagnosis.

29-08-2001

3005

Valdecoxib gel

Each gm of gel contains; valdecoxib-10mg

RMP- for the treatment of local symptomatic relief of acute musculoskeletal disorders, post traumatic inflammatory pain.

08/10/2003

3006

Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U).

For deep vein thrombosis.

08/06/2006

3007

Ceftibuten caps/suspension

i)-Each cap contains; ceftibuten-200mg,400mg, ii)-Each 5ml suspension contains (on reconstitution); ceftibuten-90mg,180mg

Upper respiratory tract infection, lower respiratory tract infections, UTI and enteritis and gastroeneteritis.

19/11/1996

3008

Chloroquine Phosphate eye drops (0.3mg/ml)

For dry eye syndrome.

13/07/2005

3009

Fexofenadine hcl suspension

Each 5ml contains; fexofenadine hcl-60mg

For paediatric & geriatric patients.

27-08-2001

3010

Fluconazole topical gel (0.5%)

Each gm of gel contains; fluconazole-5mg

By dermatologists-for the treatment of topical fungal infection due to tinea cruris and tinea corporis.

13/08/2004

3011

Memantine 5mg /10mg + Donepezil 5mg Tablets

For moderate to severe Alzheimer's disease.

31.01.08

3012

Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection

For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only.

15.03.11

3013

Olopatadime Ophthalmic solution (0.2%) (additional Strength)

As approved

24.04.07

3014

Pravastatin tabs

Each uncoated tablet contains; pravastatin sodium-10mg, 20mg, 40mg

By RMP- primary hypercholesterolemia type IIa, IIb and prevention of cardiovascular events in adults only.

20-12-2000

3015

r-follicle stimulating hormone (FSH)

NOC issued for additional strength of 37.5IU

19-08-1999

3016

Rofecoxib + paracetamol fdc tabs

Each tab contains; rofecoxib-25mg, paracetamol-500mg

By RMP- for the management of acute pain in adults only.

2003-October

3017

Ropinirole 6mg ER Tablets (Addl. Strength)

Same as approved

06.02.10

3018

Sucralfate + metronidazole cream

Each gm contains; sucralfate-0.07g, metronidazole-0.01g

Bedsore, haemorrhoids, fistulae & fissures.

29-04-2002

3019

Topiramate tablets & sprinkle capsules

For additional indication.

2004-October

3020

Zoledronic Acid Injection 5mg/100ml (Addl. Indication)

For the treatement of osteoporosis in post-menopausal women and in men who are at increased risk offracture,including those with a recent low-trauma hip fracture.

07.01.09

3021

2-Bromo-2-nitropropan-3-diol

1975- April

3022

Aspirin DL lysine

Each vial contains; Aspirin DL Lysine-900mg

1986-April

3023

Bacillus calusii spores suspension (2billion/5ml vial)

Each vial of oral suspension contains; spores of Bacillus clausii 2 billions/5ml

RMP- For the treatment of the alteration of intestinal bacterial flora.

28-01-2005

3024

Beclomethasone Dipropionate

Beclomethasone Dipropionate-0.025%, Beclomethasone Dipropionate-0.025%+Neomycin Sulphate-0.5%, Beclomethasone Dipropionate-0.025%+ Chinoform-3%

1974-April

3025

Bitoscanate

Anthelmintic

1970- April

3026

Budesonide inhaler

Each metered inhaler supplies; budesonide-200mcg.

Anti asthmatic- Indicated in the treatment of bronchial asthma.

1988-February

3027

Carboprost Tromethamine

Each mL sterile solution contains; Carboprost Tromethamine eq. to 250mcg of carboprost

Abortificient- for the treatment of second trimester abortions only.

1979-March

3028

Carnecaine injection

Carnecaine 2%-20mg articaine.

1987-February

3029

Carvedilol (already approved) new strength 3.125mg/6.25mg

3.125mg, 6.25mg

In treatment of congestive hearth failure (CHF)

10/03/1999

3030

Centella Asiatica

Each vial contains; Extract of Centella Asiatica-2%, Each tablet contains; Extract of Centella Asiatica-200mg, Ointment-Extract of Centella Asiatica-1%, Powder-Extract of Centella Asiatica-2%

1976-May

3031

Chlorphenoxamine hcl

Each tablet contains; Chlorphenoxamine Hcl-12mg, caffeine IP-30mg

1972- July

3032

Cilostazol tab & bulk

Each tab contains; cilostazol-50mg, 100mg

For treatment of stable intermittent claudication, acting or cramping in legs that occure with walking.

23-01-2003

3033

Cisplatin injection/bulk

Each vial contains; cisplatin-10mg,50mg

Anticancer- Indicated in treatment of metastatic testicular & metastatic ovarian tumours.

1982-April

3034

Citicholine Syrup 750mg/5ml

For the treatment of disturbance of consciousness resulting from head injuries, brain operation and acute stage of cerebral infarction in adults only.

04.01.08

3035

Cloxacillin sodium + Colistime sulphate intramammary infusion

Each (10ml) syringe contains; cloxacillin sodium-200mg, colistine sulphate-50000 units

04/03/1998

3036

Combination of Oxethazaine, aluminium hydroxide & magnesium hydroxide

Antacid, demulcent & mucosal anaesthetic.

1966- June

3037

Dehydro-emetine

Anti-emetine (synthetic).

1963- April

3038

Diethylamine Salicylate + Nopoxamine

Each 100gm contains; Diethylamine Salicylate-10gm, Nopoxamine-1gm

1980-March

3039

Dimethyl Fumarate delayed release 120 mg/240 mg

Each delayed release capsule contains; dimethyl fumerate-120mg, 240mg

For "Relapsing remitting multiple sclerosis".

27.08.14

3040

Diphenylpyraline hydrochloride

Each capsule contains; 5mg of diphenyl pyraline hcl

Allergic reaction, rhinitis, urticaria, eczema (anti-histamine).

1969- April

3041

Doripenem (as monohydrate) Injection 250mg/500mg

Each vial contains; doripenem monohydrate eq.to doripenem-250mg, 500mg

For the treatment of nosocomial pneumonia in adults.

16.02.09

3042

Dronedarone (as Hydrochloride) film coated tablet .... 400 mg.Â

Each film coated tablet contains; dronedarone hydrochloride eq.to dronedarone-400mg

To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabÞ¡

09.04.10

3043

Emphagliflozin Tablet 10/25 mg

Each film coated tablet contains; empagliflozin-10mg, 25mg

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes Mellitus.

07.05.15

3044

Flucortolone & flucortolone caproate

Acute & chronic eczema, allergic dermatosis.

1968- July

3045

Fluvastatin Tablet (As calcium) 10mg/20mg/40mg (additional strength)

As approved

29.01.07

3046

Fosinopril sod.tab & bulk

Each tab contains; fosinopril sodium-10mg,20mg,40mg

Mild to moderate hypertension.

10/01/2002

3047

Hydroxyethyl theophylline + Theophylline Monohydrate

Each sustained release tablet contains; Hydroxyethyl theophylline-231 mg, Theophylline Monohydrate-69mg

1981-June

3048

Ibuprofen + Paracetamol tablets

Each tablet contains; ibuprofen-400mg, paracetamol-325mg

1984-October

3049

Ilaprazole Tablets 5mg/10mg

Each enteric coated tablet contains; ilaprazole-5mg, 10mg

For the treatment of duodenal ulcer in adults only.

05.04.11

3050

Erdosteine Powder for oral suspension 35mg/ml

For chronic obstructive bronchitis.

06/02/2006

3051

Irbesartan + hydrochlorthiazide

Each uncoated tablet contains; irbesartan-150mg,300mg, Hydrochlorthiazide-12.5mg

By RMP- for mild to moderate hypertension.

31-01-2001

3052

Iron (III) isomaltoside 1000 solution for injection/infusion 100mg per ml

Each ml contains; Iron (III) isomaltoside 1000-100mg

For the treatment of iron deficiency anaemia when oral iron preparations are ineffective or cannot be used and when there is a clinical need to deliver iron rapidly.

20.08.13

3053

Levocetrizine 2Hcl + Pseudoephedrine hcl SR tablets

Each uncoated tablet contains; levocetrizine 2Hcl-2.5mg,5mg, pseudoephedrine hcl SR-120mg

By RMP- for the treatment of seasonal allergic rhinitis.

29/01/2004

3054

Lynestrenol 2.5mg & Mestranol 0.075mg

100 mg tabs (22 tablets)

Oral contraceptive

1967- April

3055

Mefloquine hcl tabs

Each film coated tab contains; mefloquine hcl eq.to mefloquine-250mg

Used in severe malaria including cerebral malaria and as a second line chloroquine resistant malaria cases only.

03/03/1997

3056

Methotrimeprazine (acid maleate)

tab-5mg, 25mg,100mg, amp- 25mg/cc

1964- January

3057

Metoclopramide C.R Tab.

Each tablet contains; metoclopramide hcl IP eq.to 15mg of the anhydrous substance.

To restore normal coordination and tone the upper digestive trac and relieve symptoms of gastro-duodenal dysfunction including heart burn,dyspepsia,nausea and vomiting associated with such conditions as reflux oesophagitis,gastritis,duodenitis and hiatus Þ¡

13/04/1992

3058

Nefopam

Each tablet contains; nefopam hydrochloride-30mg, Each ml contains (injection) nefopam hydrochloride-20mg

Non narcotic analgesic- Acute and chronic pain, including post-operative pain, dental pain, musculo-skeletal pain, acute traumatic pain and cancer pain.

1991- April

3059

Nintedanib soft Gelatin Capsule 100/150mg (Additional indication)

Each soft gelatin capsule contains; nintedanib ethanesulfonate eq.to nintedanib-100mg, 150mg

In combination with docetaxel for the treatment of adult patients with locally advanced metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first line chemotherapy.

01.04.16

3060

Norethisterone B.P.

Each tablet contains; Norethisterone B.P-0.35mg

1977-May

3061

N-Phenylethyl anthranilic acid

N-Phenylethyl anthranilic acid-300mg

1978-April

3062

Olanzapine

Each tablet contains; 5mg,7.5mg,10mg,2.5mg

For treatment of schizophrenia in adults

27-01-2000

3063

Piroxicam betacyclodextrin tabs

Each tablet contains; piroxicam betacyclodextrin eq.to 20mg piroxicam.

Pain and inflammation associated with rheumatoid arthritis, osteoarthritis, acute musculo-skelital pain, tendinitis, bursitis, post traumatic disorders, post operative pain, primary dysmenorrhoea.

25/03/1996

3064

Polythiazide

2-4 mg daily

Non-mercurial oral diuretic & hypotensive.

1962- February

3065

P-Piperidineethoxy-O-Carbomethoxy Benzophenone Hydrochloride

5mg to 10mg

Antispasmodic and analgesic.

1961- February

3066

Praziquantel tablets

Each tablet contains; praziquantel-600mg

Neurocysticercosis- in the treatment of infections brought about by the larvae of pork tapeworm in the CNS.

1985-August

3067

Prednisolone stearoylglycolate

Each tablet contains; prednisolone stearoylglucolate-6.65mg, ointment- 1.9g, cream & ointment- 1.9 g

1971- February

3068

Ranitidine syrup

Each 10ml contains; ranitidine hcl eq.to ranitidine-150mg

1990- February

3069

Rifampicin syrup

1983-June

3070

Ritodrine hcl tablet

Each tablet contains; ritodrine hcl-10mg, Ritodrine hcl injection Contains; ritodrine hcl-USP 10mg (appr.on 10-3-95)

Premature labours, acute foetal distress, prevention of preterm labours after operations.

21/02/1995

3071

Sulphamethoxy diazine

Antibacterial

1965- February

3072

Sultamicillin tablets

Each film coated tablet contains; sultamicillin (as tosylate)-375mg (eq.to sulbactum 147mg and ampicillin 220mg)

In the treatment of intra abdominal infections, obstetrics and gynaecological infections, skin and soft tissue infections, bone and joint infections, upper and lower respiratory tract infections, ENT infections, urinary tract infections, gonorrhoea and suÞ¡

06/05/1994

3073

Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet

For BPH.

06/02/2006

3074

Tenoxicam tablet

Each tablet contains; tenoxicam-20mg

NSAID- rheumatoid arthritis, osteoarthritis, arthrosis, ankylosing spondylitis, gout, non-articular rheumatic conditions.

29/04/1993

3075

Theophylline Anhydrous + Ephedrine Hcl + Diazepam + prednisalone

Each tablet contains; Theophylline Anhydrous-100mg, Ephedrine Hcl-10mg, Diazepam-1mg, prednisalone-1.5mg

1973-March

3076

Trametinib 0.5mg/2mg tablets

Each film coated tablet contains; Trametinib dimethyl sulfoxide eq. To 2mg Trametinib, Each film coated tablet contains; Trametinib dimethyl sulfoxide eq. To 0.5mg Trametinib

As a monotherapy and in combination with Dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.

18.01.17

3077

Tripotassium dicitrato bismuthate

1989-March

3078

Ulinastatin for Injection 50000 IU / 100000 IU

For the treatment of severe sepsis.

03.04.12

3079

Concentrated potassium chloride inj.

Each 100/ml contains; pot.chloride-746mg,1.49gm,2.24gm,2.98gm

For treatment of potassium deficiency states when oral replacement is not feasible.

29-04-2002

3080

Coseal Surgical Sealent 2/4/8ml (Addl. Indication)

(1) Enforcement of suture and staple lines in lung resection procedures. (2) Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation. (3) Patients undergoing laparotomy or laproscopÞ¡

06.02.10

3081

Dasatinib 20mg/50mg/70mg (Additional Indication)

Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase.

16.03.11

3082

Doxifluridine Capsules 100mg/200mg

For carcinoma of the stomach, colon, rectum, breast, uterine, cervix and bladder.

31.01.08

3083

Fotemustine i.v injection

Each vial contains; fotemustine powder-208mg (with solven)

In the treatment of disseminated malignant melanoma including cerebral localisation and primary malignant cerebral tumours.

23/12/1996

3084

Ginger extract caps.& bulk

Each cap.contains; standardised ginger ext.-200mg

Adjunct therapy in minimising drug induced emesis associated with cancer chemotherapy.

29-08-2001

3085

Icodextrin 7.5% peritoneal dialysis solution

For peritoneal dialysis.

08/06/2006

3086

Leflunomide film coated tablets

Leflunomide film coated tablet-10mg

For additional indication- active psoriatic arthritis in adults only.

30/08/2004

3087

Liposomal doxorubicin hcl

Liposomal doxorubicin hcl pegylated inj. 2mg/ml

Additional indication-for the treatment of metastatic carcinoma of the ovary in patients with diseases, refractory to both paclitaxel and platinum based chemotherapy.

29-11-2000

3088

Mecobalamine E.R. Tablet (1500mcg)

For neuropathic pain.

19/07/2005

3089

Metadoxine hcl bulk & tabs

Each uncoated tablet contains; metadoxine (as hcl)-500mg, each 1ml of iv/im injection meta doxine-60 mg.

specialist only- for the treatment of fatty liver due to alcoholism, acute and chronic intoxication of alcohol.

24-10-2003

3090

Misoprostol Tablet 600mcg

Additional strength.

09.01.09

3091

Topiramate tablets (finished formulation)

Each tab contains; topiramate-25mg,50mg,100mg,200mg,300mg,400mg, each sprinkle cap.contains topiramate-25mg,50mg (appr on 12-2-2001)

In the treatment of partial and generalized tonic clonic seizures.

23-08-1999

3092

Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet

For the treatment of iron deficiency anaemia in adults only.

21.03.11

3093

Divalproex sodium tablets

Extended release tablets-250mg,500mg,125mg

For additional indication-prphylaxis of migraine headache in adults with warning -not for women who are pregnant or planning for pregnancy.

2004-August

3094

Eptifibatide i.v injection (finished formulation)

Each 10ml vial contains; eptifibatide-2mg/ml, Each 100ml vial contains; eptifibatide-0.75mg/ml

In treatment of patients with acute coronary syndrome & patients undergoing percutaneous coronary intervention.

25-08-1999

3095

Haemodialysis Powder/Liquid Form containing citrate

For use for patients being treated by hemodialysis.

19.08.08

3096

Interferon alfa-2b (Human serum albumin free solution) injection.

Each vial contains; recombinant interferon alpha-2b 3mIU, 5mIU, 10mIU, 18mIU, 25mIU

For use in cancer-hospital/institution and against the prescription of specialistsonly- for multiple myeloma, AIDS related kaposis sarcoma, malignant melanoma, hairy cell leukemia, chronic myelogenous leukemia, laryngeal papillomathesis, condylomata, acumÞ¡

27-12-2000

3097

Lactulose powder for oral solution

Each pouch contains; lactulose B.P-10gm,20gm

Constipation

03/09/2001

3098

Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg

Anti-epileptic.

08/06/2006

3099

Levocetirizem 2Hcl. Dispersible tablet (2.5mg)

For allergic rhinitis & chronic urticaria.

08.05.07

3100

Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules

For the treatment of vitamin deficiency states in adults.

14.01.09

3101

Nicotine polacrilex gum

30-04-2002

3102

Olmesartan Medoxomil (5mg/20mg/40mg) Tablet

Each tablet contains; olmesartan medoxomil-5mg, 20mg, 40mg

Anti-hypertension.

21/07/2005

3103

Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets

For the treatment of adult patients with peripheral neuropathy.

09.02.10

3104

Verteporfin powder for solution for infusion 15mg vials

For additional indication- "subfoveal choroidal neovascularization (CNV) secondry to other macular disease like pathologic myopia & ocular histoplasmosis syndromes"

15-10-2003

3105

Ambroxyl hcl SR+ Doxycycline hcl

Each tab contains; ambroxol (as hcl) SR-75mg, doxycycline hcl-100mg

Acute and chronic illness of RT with pathological inspissation of mucous (in case of acute attacks of chronic bronchitis, inflammation of the para nasal sinuses) caused by doxycycline sensitive actiological agents.

23-08-2001

3106

Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength)

As approved

07.05.07

3107

Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet

Anti-biotic.

08/06/2006

3108

Aspirin (EC Tablets) 75mg/75mg/150mg + Rosuvastatin (Granules) 5mg/10mg/10mg Capsules

For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease.

30.03.11

3109

Buprenorphine hcl + Naloxone sublingual tablets

Each sublingual tab contains; buprenorphine hcl eq.to bprenorphine-2mg, naloxone hcl eq.to naloxone-0.5mg

2004-August

3110

Carmustine (polifeprosan 20 with carmustine Implant (Wafer)

1) In newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. 2) In recurrent glioblastoma multiforme patients as an adjunct to surgery.

31.01.08

3111

Conjugated estrogen + MPA tabs (finished formulation)

Each sugar coated tab contains conjugated estrogen-0.625mg, MPA-2.5mg,5mg

Indicated in women with an intact uterus to reduce the risk of endometrial and prevention and management of osteoperosis, and vasomotor symptoms associated with estrogen deficiency.

13-09-1999

3112

Heta starch in NaCl I.V inj

Each 100 ml contains; hydroxyethyl starch (mol.wt. 450000Da)-6gm, NaCl-0.9gm

For the treatment of hypovolemia.

29-04-2002

3113

Infliximab i.v injection

Each 10ml vial contains infliximab-100mg

For treatment of moderate to severly active crohn's disease for the reduction of signs and symptoms in patients who have an inadequate response to conventional therapies.

25-01-2000

3114

Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)

For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart ratÞ¡

10.02.10

3115

Metoprolol tartrate tablets 50 mg (Addl. Indication)

Adjunct to the treatement of Hyperthyroidism.

14.01.09

3116

Ursodeoxycholic Acid (600mg) S.R Tablet

UDCA (600mg) sustained release.

For treatment of i) primary billiary cirrhosis & ii) gallstones

20/07/2005

3117

Valsartan + S(-) amlodipine

Each hard gelatin capsule contains; valsartan-80mg, s(-)amlodipine (as besylate)-2.5mg

By RMP- for treatment of hypertension.

2003-November

3118

Cimetropium Bromide tablet 50mg

For the treatment of irritable bowel syndrome.

31.01.08

3119

Collagen fleece

For surgical procedure.

03/02/2000

3120

Combipacks (triple chambered bag) of aminoacid+electrolytes' dextrose (15% & 30%) and IV fat emulsion(LCT/MCT 20% w/w)

By RMP

2003-November

3121

Diptheria + tetanus toxoid + pertusis vaccine adsorbed & haemophilus bCRM197. conjugated vacc.

For active immunization of children (2 months-5 years) against diptheria, tetanus, pertusis & haemophilus-B diseases.

12/10/1999

3122

Efavirenz tab

Each film coated tab contains; efavirenz-600mg

Higher strength

30-04-2002

3123

Etodolac ER tablets 400mg/500mg

Each extended release tablet contains; etodolate-400mg, 500mg

For the treatment of osteoarthritis & rheumatoid arthritis.

08.05.07

3124

FDC of Amlodipine (5mg) + Bisoprolol (2.5mg)

Each tablet contains; amlodipine-5mg, bisoprolol fumerate-2.5mg

For the treatment of mild to moderate hypertension in adults.

22/07/2005

3125

Levonorgestrel tabs

Each tab.in packs of 2 tabs contain; levonorgestrel-0.75mg

Emergency contraception in women.

06/09/2001

3126

Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate3.33mg per 5ml

For symptomatic treatment of constipation in adults.

29.01.09

3127

Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength)

Anti-HIV

08/06/2006

3128

Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Pack size)

Same as approved

10.02.10

3129

Rosuvastatin Calcium Tablets 5/10/20mg (Additional Indication)

1. As adjunct to diet to reduce Total-C, LDL-C, and ApoB levels in adolesent boys and girls, who are at least one year post-menarche, 10-17 years of age with heterozygous hypercholesterolemia if after an adequate trial of diet therapy the following findinÞ¡

05.04.11

3130

Sucralfate + Metronidazole + Lignocaine hcl cream

Each gm of topical cream contains; sucralfate-0.07gm, metronidazole-0.01gm, lignocaine-0.04gm

For RMP- for the treatment of bedsore, haemorrhoids, fistulae and anal fischers.

23/08/2004

3131

Amorolfine nail lacquer & cream

Each ml of nail lacquer contains; amorolfine hcl eq.toamorolfine-50mg, Each gm of cream contains; amorolfine hcl eq.to amorolfine-2.5mg

By Dermatologists- nail lacquer:for oncomycosis caused by dermatophytes yeasts & moulds. Cream:for treatment of dermatomycosis caused by dermatophytes cutaneous candidiasis and pityriasis versicolor.

25-11-2003

3132

Ceftriaxone + Tazobactum Injection

Each vial contains; ceftriaxone-1000mg, tazobactum sodium eq.to tazobactum-125mg

For the treatment of patients with community acquired pneumonia and lower respiratory infection.

21/07/2005

3133

Certoparin sodium inj. (finished formulation)

1 disposible syringe of 0.3ml solution contains certoparin sodium-3000 IU

For thromboembolism prophylaxis only. Antifactor Xa.

1999-October

3134

Cyclobenzaprine Hcl. Tablets 5mg/10mg

Each film coated tablet contains; cyclobenzaprine Hcl-5mg, 10mg

As adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

22.04.08

3135

Everolimus tablets

Each tablet contains; everolimus 0.25mg,0.5mg,0.75mg,1.0gm, Each dispersible tablet contains; everolimus-0.1mg,0.25mg

By nephrologists only- for the prophylaxis of organ rejection in patients at low to moderate immunological risks receiving allogenic renal transplants in combination with cyclosporin & corticosteroids.

2004-August

3136

FDC of Ambroxol + guaiphenesin

Each tab contains; ambroxol hcl-30mg, guaiphenesin-200mg

For cough & congestion.

10/09/2001

3137

Stanozolol

Each tablet contains; Stanozolol-2mg

1973-March

3138

Glycopyrrolate + neostigmine inj.

Each 5ml contains; glycopyrrolate-500mcg, neostigmine methyl sulphate-2500mcg

Reversal of residual non-depolarising competitive neuromuscular block.

11/04/2002

3139

Ipratropium bromide + salbutamol sulphate

Each actuation delivers; salbutamol sulphate eq.to salbutamol-100mg, ipratropium bromide BP-20mcg

In treatment of chronic obstructive pulmonary disease.

06/03/2000

3140

Ketorolac Tromethamine Ophthalmic Solution 0.45%

Indicated for the treatment of pain and inflammation following cataract surgery.

10.02.10

3141

Levosulpiride tablet (25mg)

Each uncoated tablet contains; levosulpiride-25mg

For the treatment of different G.I. problem like fanatical dyspepsia, nausea, vomiting and diabetic gastroparesis.

10.05.07

3142

Olopatadine Ophthalmic solution( 0.1%)

For allergic conjunctivitis.

08/06/2006

3143

Quetiapen fumarate Sustained Release Tablets 50mg and 100mg (Additional Strength)

Same as approved

05.04.11

3144

Ranolazine 1000mg ER Tabs (Additional Strength)

Same as approve

31.01.09

3145

Betamethasone diprop.+ salicylic acid lotion

Each ml contains; betamethasone diprop.-0.064%, salicylic acid-3%

New formulation- for treatment of keratosis, ichthysis, lichen planus & dry scaly conditions of skin.

14-05-2002

3146

Biomesh' GTR barrier (biodegradable)

An aid to promote regeneration and integration of peridontal tissue components after surgical procedure.

01/12/1999

3147

Cytarabine Injection 100mg Additional Packsize (20ml)

In combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic Þ¡

10.02.10

3148

Day & night capsules

Combikit of 5 tablets each i)-pseudoephedrine hcl ER-120mg + cetrizine hcl-5mg (orange tab) ii)-pseudoephedrine hcl ER-120mg + Tripolidine-2.5mg (blue tabs)

By RMP- for the treatment of symptomatic relief of allergic rhinitis in adults only.

2004-August

3149

Esomeprazole magnesium Delayed Release Tablets 20mg/40mg (Additional Indication)

1. Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Ulcer. 2. Risk Reduction of NSAID Associated Gastric Ulcer. 3. Prolonged Treatment after IV Induced Prevention of Rebleeding of Peptic Ulcer.

06.04.11

3150

Faropenem Sodium (150mg/200mg) Tablet

Each film coated tablet contains; faropenem sodium eq.to faropenem-150mg, 200mg

For the treatment of respiratory tract infection, UTI, skin & skin structure infection & gynaecological infection.

21/07/2005

3151

Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg.

For iron deficiency anemia.

08/06/2006

3152

Fluvastatin sodium

25-11-2003

3153

Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml

For intradermal implantation and facial soft tissue augmentation.

31.01.09

3154

Piroxicam transdermal patch

3155

Rimonabant tablet 20mg

For Obese Patients BMIâ?¥ 30kg/m2 or overweight patients BMIâ?¥ 27kg/m2 with Associated risk factors such As type-I diabetes or dyslipidemia.

11.05.07

3156

Sertaconazole Nitrate Cream 2%,

For the topical treatment of the superficial mycosis like dermatophytosis.

31.01.08

3157

Tolterodine-L-tartrate

Each tab contains; tolterodine-L-tartrate-2mg eq.to tolterodine-1.37mg

For treatment of patients wth symptoms of over active bladder including urinary frequency & urgency with or without urge inconsistence.

13-09-2001

3158

Bambuterol hcl (bulk locally) (D.F 22-4-94)

Bronchospasm in asthma, reversible air ways disease.

13-12-1999

3159

Caspofungin acetate Injection (Addl. Indication)

For use in following: (I) Empirical therapy for presumed fungal infections in febrile neutropenicpatients. (II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleural space infections. (III) TreatmÞ¡

31.01.09

3160

Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength)

Same as Approved.

31.01.08

3161

Cefpodoxime IP 100mg/100mg/200mg/200mg + Ofloxacin IP 100mg/200mg/100mg/200mg Tablets

For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only.

16.04.11

3162

Clotrimazole lozenges

Clotrimazole-10mg

For local treatment of oropharyngeal candidiasis in immuno compromised patients.

13-03-2000

3163

Ezetimib tabs

Each tab contains; ezetimib-10mg

By RMP only- for the treatment of primary hypercholesteromia homozygus familial hypercholesterolemia.

17-12-2003

3164

Lactilol monohydrate Syrup 66.67/100ml

Each 100ml syrup contains; lactilol monohydrate BP-66.67gm

For the treatment of constipation.

16.05.07

3165

Lamotrigine SR tablets

Each SR tablet contains; lamotrigine-50mg,100mg,200mg.

By neurologists-as add on therapy for partial and secondry generalized tonic-clonic seizures in adults not below 16 years of age.

27/08/2004

3166

Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg) + Entacapone (200mg) tablet

For Parkinsonâ??s disease.

25/07/2005

3167

Metronidazole colon drug delivery system

Each tab contains; metronidazole-400mg

New formulation- for treatment of intestinal amoebiasis & giardiasis in adult patients.

14-05-2002

3168

Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication)

For the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older.

10.02.10

3169

Super Oxidized Solution (containing Water 99.9% with salts like sodium hypochlorite, hypochlorous acid, hydrogen peroxide ozone, chlorine chloride, sodium hydroxide, sodium carbonate and sodium chloride)

For use as cleaning and debriding agents in wounds management & care.

12/06/2006

3170

Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution

For cleansing of physically contaminated wounds and for preoperative disinfection.

09.02.09

3171

Triple chamber bags for peritoneal dialysis soln.B.P

Compartment A-61ml; each 1000ml contains; dextrose IP eq.to dextrose anhydrous-453.0gm NaCl IP-5.67gm, water for injection-q.s, Compartment B-104ml; each 1000ml contains;dextroseIP eq.todextrose anhy-453.0g, NaCl IP-5.67g, WFI-q.s, Compartment C-1969ml;eaÞ¡

For peritoneal dialysis.

25-09-2001

3172

Bulaquine compound 80/53 (local bulk mfg),(D.A.R 25-5-87)

For vivax malaria only.

21-12-1999

3173

Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form )

Same as approved

20.04.11

3174

Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets

For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

31.01.08

3175

Ebastine tab & bulk

Each tab (film coated) contains; ebastine-10mg

For Seasonal & prennial allergic rhinitis & chronic idiopathic urticaria.

28-09-2001

3176

Enoxaparin sodium inj.

For additional indication: prophylaxis of deep vain thrombosis.

16-03-2000

3177

Glibenclamide + Metformin SR tablets

Glibenclamide-2.5mg,5mg, metformin-500mg

20/08/2004

3178

Linezolid dry powder for suspension

Each 5ml reconstituted suspension contains; linezolid-100mg

Bt RMP-for the treatment of complicated/uncomplicated skin and skin structure infection and community acquired pneumonia.

05/01/2004

3179

Methyl Prednisolone Aceponate Cream (0.1%)

Each gm of cream contains; Methyl prednisolone acetate 1mg

For treatment of Atopic dermatitis (exzema) inflammatory & allergic skin reaction.

15/06/2006

3180

Nicotine ploacrilex lozenges (additional Indication)

To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthkacontaining tobacco.

03.02.09

3181

Quetiapine fumerate tablets

Each film coated tab contains; quetiapine fumerate eq.to quetiapine 25mg,50mg(additional strength on 28-10-2002),100mg,200mg,300mg

For the management of the manifestation of of psychotic disorders (schizophrenia)

03/06/2002

3182

Saquinavir (as mesylate) 500mg Tablet

Addl.Strength.

25/07/2005

3183

S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate) 2.5/5mg

For essential hypertension

16.05.07

3184

Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion

Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present.

11.02.10

3185

Amifostine injection

Amifostine-500mg/vial. On reconstitution, amifostine-50mg/ml (same as approved on 26-3-96)

Shelf life extended 24 months to 36 months.

01/09/2004

3186

Amlexanox Oral Paste (5%)

Each gram of paste contains; amlexanox-50mg

For the treatment of apthous ulcers in people with normal immune system.

16.05.07

3187

Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules)

For the treatment of respiratory tract infection, skin and soft tissue infections & antibiotics associated diarrhoea in adult patients.

31.01.08

3188

Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength)

As loading dose for prevention of in-stent restenosis in PCI.

22/06/2006

3189

Atorvastatin calcium 5mg/10mg/20mg/40mg/80mg (Additional Dosage Form)

1) As an Adjunct to Diet to Reduce Elevated Total Cholesterol and Triglyceride Levels in Patients with Primary HyperCholesterolemia and Mixed Dyalipidemia (Type IIa and IIIb). 2) In adult patients with type II diabetes and without clinically evident coronÞ¡

20.04.11

3190

Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier

As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement.

11.02.10

3191

Combipack of Desogestrel and Ethinyl estradiol

for oral contraceptive in women only.

29/05/2000

3192

Glimepiride + rosiglitazone

Glimepiride-1mg, rosiglitazone-4mg

For the treatment of type-II NIDDM.

12/12/2003

3193

Itopride hcl tab & bulk

Each film coated tab contains; itopride hcl-50mg

G.I symptoms caused by reduced G.I motility (like feeling of gastric fullness, upper abdominal pain, anorexia, heart burn, nausea & vomiting in non-ulcer dyspepsia or chronic gastritis.

09/05/2002

3194

Lornoxicam 4mg + Paracetamol 500mg film coated tablets

For the short term use in acute painful & inflammatory conditions in adults.

05.02.09

3195

Ofloxacin ER tab

Each tablet containing ofloxacin-400mg, 800mg

By RMP- for LRTI, complicated UTI, uncomplicated skin, soft tissue infections.

20-09-2001

3196

Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg)

Each tablet contains; pramipexole dihydrochloride monohydrate-0.125mg, 0.25mg, 0.5mg, 1mg, 1.5mg

For the treatment of the signs and symptoms of idiopathic Parkinsonâ??s disease.

25/07/2005

3197

Ripaglinide

Each tablet contains; 0.25mg,0.5mg,1.0mg,2mg

Treatment of type-II diabetes (NIDDM) whose hyperglycemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.

23-03-2000

3198

Alprostadil for injection

Each single dose syringe contains; alprostadil USP-10mcg,20mcg

Treatment of erectile dysfunction in men. Endocrinologists/urologists/psychiatrists/venereologists only

09/05/2002

3199

Cefotaxime sodium + sulbactam sod. Inj.

Each vial contains; sterile cefotaxime sodium USP eq.to cefotaxime-500mg,1000mg, sterile sulbactam sod.USP eq.to sulbactam-250mg,500mg

RMP & gynaecologists only- for the treatment of lower respiratory tract infection and genito urinary tract infection.

26-12-2003

3200

Fludarabine Phosphate for Injection

Each vial contains; fludarabine phosphate 50mg eq.to 39.05mg of fludarbine

The treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) who have not responded to at least one standard alkylating agent containing regimen.

22/06/1999

3201

Fluvestrant 250mg/5ml Injection(Additional Dosage Regime)

(Same as approved) Posology : Adult females (Including the elderly). The recommended dose is 500mg at interval of one month, with an additional 500mg dose given two weeks after initial dose.

20.04.11

3202

Halobetasol 0.5mg + Miconazole 20mg per gram Cream

For steroid responsive dermatoses associated with superficial fungal infection of skin.

31.01.08

3203

Leflunomide tab

Each film coated tab contains; leflunomide-10mg,20mg,100mg

For active rheumatoid arthritis in adults only.

01/10/2001

3204

Lenalidomide capsule (5mg/10mg /15mg/25mg)

Each capsule contains; lenalidomide-5mg, 10mg, 15mg, 25mg

For the treatment of patients with transfusion dependent anemia due to low or intermediate-1-risk myalodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

16.05.07

3205

Levofloxacin 0.5% Ear drops

For otitis media.

27/06/2006

3206

Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets

For the treatment of patients with acute painful musculoskeletal conditions.

12.02.10

3207

MMR Vaccine

29-03-2000

3208

Montelukast tablets

Montelukast-4mg,8mg,10mg

For additional indication- relief of symptoms of seasonal allergic rhinitis in adults only.

2004-September

3209

Acarbose tablets

Each tab contains; acarbose-50mg,100mg

Insulin dependent (type-II) diabetes inadequately controlled by diet/or oral hypoglycaemic agent.

06/03/1997

3210

Alectinib capsules 150mg

Each hard capsule contains; Alectinib 150mg eq. To Alectinib hydrochloride 161.3mg

For the treatment of patients with anaplastic lymphoma kinase (ALK)-Positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Crizotinib.

23.01.17

3211

Alogliptin Tablet 6.25 mg/12.5 mg/ 25 mg

Each film coated tablet contains; alogliptin-6.25mg, 12.5mg, 25mg

"To improve glycemic control in combination with other glucose lowering medicnial products including insulin when these together with diet and exercise, do not provide adequated glycemic control or as monotherpy as adjunct to diet and exercise to improve Þ¡

27.08.14

3212

Amlodipine besylate + Atorvastatin tablets

Each uncoated tablet contains; amlodipine besylate eq.to amlodipine-5mg, atorvastatin calcium eq.to atorvastatin-10mg

By RMP- for the treatment of coexisting essential hypertension and hyperlipidaemia.

11/02/2004

3213

Amoxicillin + Carbocisteine

Each capsule contains; amoxicillin-250mg,500mg, carbocisteine-150mg, Each 5ml syrup contains; amoxicillin-125mg, carbocisteine75mg.

For respiratory infection characterized by excessive or viscous mucus, contraindicated in pregnancy.

1991- April

3214

Amoxycillin Trihydrate

Each dispersible tablet contains; Amoxycillin Trihydrate eq to 125mg of amoxycillin

1980-March

3215

Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial

Each vial contains; anidulafungin-50mg, 100mg

For the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients.

26.02.09

3216

Asenapine Maleate Sublingual Tablets 5mg/10mg

Each sublingual tablet contains; asenapine maleate eq.to asenapine-5mg, 10mg

For acute treatment of schizophrenia in adults only.

07.04.11

3217

Blonanserin Tablet 2mg/4mg/8mg

For the treatment of Schizophrenia in adult patients when first line treatment is ineffective.

24.04.12

3218

Buprenorphine hydrochloride

Each ml contains; buprenorphine hydrochloride eq.to 0.3mg of buprenorphine

Narcotic analgesic- Indicated in the treatment of post-operative pain, pre-medication before surgery & myocardial pain.

1986-April

3219

Carbamazepine C R tablets

Each C.R film coated tablet contains; carbamezepine-200mg,400mg

17/05/1993

3220

Carnecaine with Adrenaline injection

Carnecaine 2% with adrenaline, carnecaine 4% with adrenaline

1987-February

3221

Cefalonium 250 mg suspension

Each 3G syringe contains; cefalonium dihydrate-250mg

For routine dry cow therapy to treat existing sub-clinical infections and to prevent new infections which occur during the dry period.

08.04.13

3222

Chlorpheniramine maleate USP

Each sustained release tablet contians; Chlorpheniramne Maleate USP-8mg

1978-April

3223

Chlorphenoxamine Embonate

Each 5mL syrup contains; Chlorphenoxamine Embonate-17.5mg

1979-March

3224

Collagenase ointment

Each gm contains; collagenase-250 units

In the treatment for debriding chronic dermal and severely burn areas.

05/05/1994

3225

Dinoprostone (PGE2)

Each tablet contains; dinoprostone (PGE2)-0.5mg

For the induction of labours.

1990- February

3226

d-Norgestrel

Each coated tablet contains; d-Norgestrel-0.03mg

Oral contraceptive

1974-April

3227

Doxazosin mesylate

Each uncoated tablet contains; doxazocin mesylate eq,to doxazocin-1mg,2mg,4mg

Mild to moderate hypertension only

11/03/1999

3228

Escitalopram oxalate tab

Each film coated tab contains; escitalopram oxalate eq.to escitalopram-5mg,10mg,20mg

For treatment of major depressive disorder & panic disorders with or without agoraphobia.

24-01-2003

3229

Frusemide + KCl

Each tablet contains; frusemide-20mg, potassium chloride-750mg

1989-March

3230

Gadobutrol 1.0mmol/ml solution for Injection

Each ml contains; gadobutrol-604.720mg

"In adult, adolescence and children aged 2 years and older for: 1. contrast enhancement in cranial and spinal magnetic resonance imaging (MRI) 2. Contrast enhancement MRI of other body regions: liver kidneys.3. Contrast enhancement in Magnetic Resonance AÞ¡

07.05.15

3231

Gentamicin sulphate

0.8mg/kg, 0.4mg/kg

Urinary tract infection.

1968- July

3232

Halobetazol Propionate Cream (0.05%)

Corticosteroid responsive dermatomes.

02.02.07

3233

Hydroflumethiazide + rauwolfia

i) HFT-25 + R-50, ii) HFT-50 + R-50, iii) HFT-25

1971- March

3234

Ketorolac tromethamine tablet/injection

Each film coated tablet contains; ketorolac tromethamine-10mg, ampoule-30mg/ml, 15mg/ml (i.m inj. Cadila 13-5-92)

Non steroidal analgesic anti inflammatory- Indicated in the treatment of short term management of post operative pain and musculo-skeletal pain.

21/04/1992

3235

Lamivudine(40mg) + Nevirapine(70mg) + Stavudine(10mg) (in5ml)powder for suspension

Anti HIV.

28/01/2005

3236

Levodopa 200mg + Carbidopa 50mg C.R. tablet

For Parkinson's Disease.

08.01.08

3237

Levonorgestrel + Ethinyloestradiol

Triquilar (Calender pack contains 21 tablets): 6 tablets-Each tablet containing Levonorgestrel-0.05mg, Ethinyloestradiol-0.03mg, 5 tablet-Each containing Levonorgestrel-0.075mg, Ethinyloestradiol-0.04mg, 10 tablets-Each contains Levonorgestrel-0.125mg, EtÞ¡

1981-August

3238

Lynestrenol

Progesterone hormone

1964- January

3239

Marcaine adrenaline

marcaine-0.25% with & without adrenaline, marcaine-0.5% with or without adrenaline

1972- September

3240

Methacycline Hcl.

Antibiotic

1966- December

3241

Methocarbamol

1gm to 1.5gm (Max. 4gm/day)

Skeletal muscle relaxant.

1961- February

3242

Nalidix acid

500 mg tablets

Urinary tract infection.

1969- April

3243

Nifedipine capsules

Each capsule contains; nifedipine USP-10mg, 5mg

1984-December

3244

Niflumic acid

Each capsule contains; Niflumic acid-250mg

Anti-inflammatory drug- indicate in the treatment of rheumatoid arthritis, osteoarthritis.

1975- April

3245

Nimustine hcl injection

Each vial contains; nimustine as hydrochloride-25mg,50mg

Anti cancer- in the remission of subjectived objective symptoms of encephaloma gastro-intestinal cancer, lung cancer malignant lumphoma & chronic leukaemia.

1985-August

3246

Norethisterone + Ethinyl oesteadiol

Each tablet contains; Norethisterone-1mg, Ethinyl oesteadiol-30mcg

1977-June

3247

Norethyndrol 2.5 mg & Mestranol 0.1 mg

145-155 mg tabs (21 tablets)

Oral contraceptive

1967- April

3248

Olanzapine

Each film coated tab contains; olanzapine-15mg

Additional strength

18-01-2002

3249

Oxacillin sodium

250mg caps

New synthetic penicillin-use in Staphy. Resistance cases.

1963- April

3250

Oxibendazole

Oxibendazole -1.33% w/w

Veterinary anthelmentic- indicated in the treatment of gastro-intestinal nematodes, infections of cattle, sheep, horses and other domestic animals.

1976-May

3251

Panobinostat hard gelatin capsule 10mg/15mg/20mg

Each capsule contains; 10mg panobinostat free base corresponding to 12.576mg of panobinostat lactate anhydrous, Each capsule contains; 15mg panobinostat free base corresponding to 18.864mg of panobinostat lactate anhydrous, Each capsule contains; 20mg panÞ¡

In combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma, who received at least 1 prior therapy.

27.03.16

3252

Penfluridol tablets

Each tablet contains; penfluridol-20mg

Long acting neuroleptic- Indicated in the treatment of schizophrenia etc.

1988-March

3253

Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.Â

Each film coated tablet contains; prasugrel hydrochloride eq.to prasugrel-5mg, 10mg

To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) asÂ follows:Â Â â?¢ Patients with unstable angina (UA) Þ¡

28.05.10

3254

Propanidiol

5% solution

Local anaesthetic

1970- May

3255

Rilmenidine tablets

Each tablet contains; rilmenidine dihydrogen phosphate eq.to 1mg of rilmenidine (base).

Mild to moderate hypertension.

21/02/1995

3256

Semduramicin sodium 5% premix

Each kg of premix contains; semduramicin-50gm (eq.to semduramicin sod.)

04/03/1998

3257

Anastrozole tab (finished formulation import)

Each film coated tab contains; anastrozole-1mg

For the treatment of advanced breast cancer in post menopausal women.

10/02/2003

3258

Thiocolchicoside tablets

Each tab contains; thiocolchicoside-4mg

25/03/1996

3259

Timolol maleate + Pilocarpine hcl

Each ml of ophthalmic solution contains; timolol maleate-5mg (as base), pilocarpine hcl-20mg

For reduction of intraocular pressure in patients with ocular hypertension or open angle glaucoma

25-01-2000

3260

Triamterene

Diurectic

1965- February

3261

Trimethoprim tablets

Each tablet contains; trimethoprim-100mg

1983-June

3262

Trypsin-Kallikrein inactivator

2-3 ampoule i.v, 4-6 amp daily

Inactivates trypsin & Kallikrein-indicated in pancreatitis.

1962- February

3263

Urokinase for inj.

Thrombolytic agent- Indicated in the treatment of pulmonary embolism and thrombo embolic disorders involving deep veins.

1982-May

3264

Vinorelbine tartrate

Each vial contains; vinorelbine tartrate eq.to vinorelbine base-10mg/ml.

By oncologists- for advanced non-small cell lung cancer as a single agent or in combination and also in metastatic breast cancer patients who have failed the standard first line chemotherapy.

29-01-2001

3265

Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets

For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections.

12.02.10

3266

Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication)

For surgical prophylaxis (additional indication).

18.05.07

3267

Clarithromycin 1% gel

Each tube contains; clarithromycin-1%

Acne vulgaris

12/06/2002

3268

Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection

For the treatment of acute colicky pain in adult patients.

28.04.11

3269

FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule

Anti-histaminic & mucolytic.

29/07/2005

3270

Fluticasone propionate + salmoterol accuhaler

Each blister contain; powder for inhaled providing fluticasone propionate-500mcg,250mcg,100mcg, salmoterol (as the xinafoate)-50mcg

For regular treatment of bronchial asthma where the use of a bronchodilator and an inhaled cortocosteroid are appropriate

29-03-2000

3271

Gemcitabine in combine with cisplatin

For additional indication

2003

3272

Infliximab inj.

Each vial contains; infliximab 100mg in 10ml

Reduction of signs & symptoms of rheumatoid arthritis in patients who have an inadequate response to methotrexate (additional indication).

04/10/2001

3273

Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution

For the treatment of dandruff.

09.02.09

3274

Montelucast 10mg + Levocetirizine 5mg film coated tablets

For the treatment of allergic rhinitis in adults only.

31.01.08

3275

Olmesartan 40mg + Hydrochlorthiazide 25mg tablet (addl. Strength)

Anti-hypertensive.

28/06/2006

3276

Ziprasidone i.m injection

After reconstitution each ml of i.m inj.contains; ziprasidone mesylate eq.to ziprasidone-20mg

By psychiatrist only- for rapid control of agitation in psychotic patients.

03/09/2004

3277

Amifostine injection

Sterile lyoplillized powder for injection

Shelf life extended 24 months to 36 months.

2004

3278

Buclizine HCl tablet (25mg) & Syrup 6mg/5ml

As appetite stimulant.

28/06/2006

3279

Celecoxib Mouth Dissolving Tablet 50/100/200 mg

For the Treatment of Osteoarthritis and Rheumatoid Arthritis.

25.02.10

3280

Cerivastatin tab

Each tablet contains; cerivastatin sodium-100mcg,200mcg,300mcg

By RMP- primary hypercholesterolemia type IIa, IIb resistant to diet.

11/05/2000

3281

FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet

Each film coated tablet contains; gabapentin-300mg, methylcobalamine-500mcg

For the treatment of neuropathic pain in adults.

05/08/2005

3282

Gatifloxacin tab & inj.

Each film coated tab contains; gatifloxacin-200mg,400mg, Each single use vial of inj.contains gatifloxacin-10mg/ml

Acute bacterial exacubation of chronic bronchitis/acute sinusitis/community acquired pneumonia/uncomplicated UTI (cystitis)/uncomplicated urethral & cervical gonorrhoea & complicated UTI

03/10/2001

3283

Halobetasol Scalp Approved 0.05% w/v

For the relief of inflammatory andpuritic manifestation of corticosteroidrespensive dermatosis.

18.02.09

3284

Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel

For short term intermittent treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance including use of sun screen.

31.01.08

3285

Isotretinoin cap. USP & bulk import

Each soft gelatin capsule contains; isotretenoin USP-10mg,20mg

Dermatologists only- cystic & conglobate acne, severe nodular acne unresponsive to antibiotic therapy.

21-06-2002

3286

Lacosamide Syrup15mg/ml (Additional Dosage Form)

Same as approved

02.05.11

3287

Lornoxicam tablet 4mg/ 8mg

Each film coated tablet contains; lornoxicam-4mg, 8mg

For symptomatic treatment of pain and inflammation in patients of osteoarthritis and rheumatoid arthritis.

21.05.07

3288

r-hu-coagulation factor VII (a) inj.

Each vial contains; r-hu-coagulation factor VII (a); 60KIU (1.2mg), 120KIU(2.4mg),240 KIU (4.8mg)

Treatment of bleeding episodes and prevention of excessive bleeding associated with surgery in patients with inherited or acquired hemophilia with inhibitors to coagulation factor VIII or IX

14/01/2003

3289

Hydroquinone 2% + Tretinoin 0.05% + Hydrocortisone 1% Cream

For the treatment of patients with skin hyperpigmentation.

23.02.09

3290

Botulinum toxin type-A

Additional indication of cerebral palsey & cervical dystonia.

08/07/2002

3291

Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength)

Anti-biotic.

06/07/2006

3292

DTP + Hepatitis B-combined vaccine (finished formulation import)

Each 0.5ml dose of vaccine contains; min.30 IU (7.5 LF) of diptheria toxoid, min.60 IU (3.2 LF) of tetanus toxoid, min.4 IU (150U) of bordettella pertusis killed, r-H-Bs Ag protein-10mcg

In children from 6 weeks onwards, by RMP, for active immunization against DTP and Hepatitis-B

25-05-2000

3293

Feracrylum 1% solution

Additional indication as antiseptic.

05/10/2001

3294

Gemcitabine injection

Additional pack size 1.4gm/vial for pancreatic cancer.

02/09/2004

3295

Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 60mg + Menthol 1mg (per 5ml) Syrup

For the treatment of common cold and cough associated with fever.

31.01.08

3296

Phenytoin Sodium (300mg) tablet

Each film coated tablet contains; phenytoin sodium-300mg

By neurologists.

05/08/2005

3297

Primaquine Tablet 45mg(Additional Strength)

Used as Gametocytocidal drug in P. falciparum infections to prevent transmission of falciparum malaria particularly in area where there is potential for re-introduction of malaria.

05.05.11

3298

Propofol 2% w/v Injection (additional Strength)

Same as Approved

27.02.10

3299

Tranexamic Acid Tab SR 750mg

For the treatment of menorrhagia.

20.02.09

3300

Abatacept Injection 250mg/vial (Addl. Indication)

In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists.

20.02.09

3301

Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops

For reduction of IOP.

05/07/2006

3302

Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules

For treatment of painful inflammatory conditions associated with gastroduodenal ulcers.

31.01.08

3303

FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment

For psoriasis vulgaris.

12/08/2005

3304

Gadobenate dimuglimine i.v inj.

Each ml contains; gadobenate acid 334 mg as dimuglimine salt.

Contrast medium for MRI of liver & CNS.

07/03/2003

3305

Ganirelix soln for inj.

Each 0.5ml of soln for inj.contains ganirelix-0.25mg

Prevention of premature leutinising hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction technique.

08/10/2001

3306

Hyaluronic Acid Pre- filled Syringe 30mg/2ml& 60mg/4ml(Additional Strength)

To Restore Visco-Elastic Properties of the Synovial Fluid, with Alleviation of Pain and improvement of Joint, Mobility in Patients Affected by Degenerative or Mechanical Arthopathy.

05.05.11

3307

Infliximab injection

For additional indication of- maintenance therapy in crohn's disease, fistulising crohn's diase and maintenance therapy in fistulizing crohn's disease.

01/09/2004

3308

Livetiracetam conc. for infusion 100mg/ml (new dosage form)

As adjunctive therapy in partial onset seizures in adults with epilepsy when oral administration is temporarily not feasible.

21.05.07

3309

Spironolactone 25mg + Furosemide 20mg tablets

For treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis.

05.03.10

3310

Tissel kit

1 ml of reconstituted tisseol solution contains; clottable protein-75-115mg, thereof fibrinogen-70-110mg, plasmafibronectin (CIG)-2-9mg, factor XIII 10-50 u2, plasminogen 40-120 mcg, aprotinin soln (bovine)-3000 KIU/ml3

For achieving hemostasis to seal or glue tissues and to support wound healing, by RMP

30-05-2000

3311

Tranexamic acid tablets/i.v inj.

Change of indication to "treatment of excessive bleeding in patients with hemophilia during & following tooth extraction".

05/07/2002

3312

Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler

As third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately.

31.01.08

3313

Citalopram HBr.

Each film coated tablet containing; citalopram HBr eq.to citalopram base 10mg,20mg,40mg

Psychiatrists only- for treatment of depressive illness in the initial phase and as maintenance therapy against potential relapse/recurence panic disorder with or without agoraphobia.

03/10/2001

3314

Combination vaccine DPT + Hi-b

Composition; Each 0.5ml dose contains; haemophilus influenza-b oligo saccharide-10mcg, diptheria CRM 197-25mcg, diptheria toxoid (adsorbed)-12.5Lf, tetanus toxoid (adsorbed)-5Lf, pertusis vaccine (adsorbed) NMT-160 PU, aluminium NMT-0.85mg, thiomersal-50mÞ¡

For active immunization of children two months-five year of age against diptheria, tetanus, pertusis and haemophilus influenza type-b disease when indication for immunization with DTP vacc & Hib conjugate vaccine coincide and is not to be used for treatmeÞ¡

01/06/2000

3315

Eplerstat tablet 50mg

For abnormality of vibration sense and abnormal change in heart rate associated with diabetic peripheral neuropathy.

25.05.07

3316

Escitalopram + Clonazepam

Each film coated tab contains; escitalopram-10mg (as oxalate0, clonazepam-0.5mg

Psychiatrist- for treatment of patients with comorbid depression & anxiety disorders.

31/08/2004

3317

FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg) + Metformin (500mg E.R) Tablet

Anti-diabetic.

12/08/2005

3318

Levocetirizine Di-HCl Syrup2.5mg/5ml (Additional Indication)

For the Treatment of Allergic Rhinitis and Chronic Urticaria in Children from 6 months of Age.

05.05.11

3319

Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet.

For symptomatic relief of Irritable bowel syndrome in adults.

06/07/2006

3320

Nebivolol tabs & bulk import

Each tab contains; nebivolol hcleq.to nebivolol-5mg

For the treatment of essential hypertension.

12/07/2002

3321

Olopatadine 5mg + Ambroxol 30mg tablets

For the management of cough in adult patients only.

05.03.10

3322

PEG-interferon alfa-2a

Each 0.5ml PFS/1 ml vial contains PEG interferon alfa-2a: 135mcg,180mcg

For treatment of multiple myeloma kaposi's sarcoma in AIDS patients with malignant neoplasia, hairy cell leukemia, chronic myelogenous leukemia, chronic active hep.B & C

13/03/2003

3323

Citicoline tablet 200mg (additional strength)

As approved

25.05.07

3324

Dorzolamide + Timolol eye drops

Dorzolamide-2%, timolol-0.5%

28/08/2004

3325

Doxyphylline 400 mg + Terbutaline 5mg tablets

For the treatment of asthma and chronic obstructive pulmonary disease in adult patients only.

23.02.09

3326

Hyaluronic acid injection

Each ml contains; hyaluronic acid-20mg in PFS

For treatment of wrinkles & folds of face & lips enhancements.

03/04/2003

3327

Inactivated purified rabies vaccine (pitman moore strain propagated on duck embryo)

Each vial contains; inactivated purified rabies virus (pitman moore strain propagated in duck embryo)-â?¥ 2.5 IU

Active immunization against rabies.

12/07/2002

3328

Ivabradine Tablets 5mg/7.5mg (Additional Indication)

For Symptomatic Treatment of Chronic Stable Angina Pectoris in Coronary Artery Disease Patients with Normal Sinus Rhythm, Indicated in Combination with Beta-Blockers in Patients Inadequately Controlled with an Optimal Beta-Blocker Dose and Whose Heart ratÞ¡

05.05.11

3329

Metformin + rosiglitazone tabs

Each uncoated tab contains; rosiglitazone maleate eq.to rosiglitazone-2mg, metformin IP-500mg

Patients with type-2 diabetes mellitus when diet exercise and the single agent do not result in adequate glycemic control.

11/10/2001

3330

Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules

For the treaetment of painful diabetic neuropathy in adults only.

05.03.10

3331

r human erythropoeitin

r Hu Epo inj-1000 IU/ml,2000 IU/ml, 3000 IU/ml, 4000 IU/ml, 10000 IU/ml

For additional indication of perisuregry. First approval on 27-1-93 vide no.12-67/88-DC

19-06-2000

3332

Solifenacin Succinate Tablet (5mg/10mg)

For overactive bladder with urge urinary incontinence urgency & urinary frequency.

06/07/2006

3333

Tenofovir Disoproxil Fumarate Tablet (300mg)

Each film coated tablet contains; tenofovir disoproxil fumarate-300mg

For the treatment of HIV-1 infection in combination with other anti-retroviral agents.

17/08/2005

3334

VSL # (Combination of lactic acid bacteria (VSL # 3)

For the treatment of irritable bowel syndrome.

31.01.08

3335

Ambroxol CR tabs

75mg

2002

3336

Calcium acetate 435mg + Magnesium carbonate 235mg tablets

For the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis).

05.03.10

3337

Clostimethate Sodium of 1,00,000IU Injection

For the treatment of serious infection caused Gram-ve bacteria including LRTI, UTI, where commonly used anti bacterial agent may be infective because of bacterial resistance.

31.01.08

3338

Cyclosporin capsules

Each capsule contains; cyclosporin 10mg.

As additional strength.

27-06-2000

3339

Gadoversetamide inj.

Each ml contains; gadoversetamide-330.9mg (0.5mm)

For use in magnetic resonance imaging in patients with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.

04/06/2003

3340

Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream

For the treatment of melasma of face in adults.

23.02.09

3341

Linezolid tabs & bulk & oral susp.

Each film coated tab contains; linezolid-400mg, 600mg, Each 5ml of reconstituted oral suspension contains; linezolid-100mg

Complicated/uncomplicated skin & skin structure infection, community acquired pneumonia.

04/10/2001

3342

Resperidone long acting injection

Each long acting injection vial resperidone-25mg,37.5mg,50mg

By psychiatrists- for the treatment of schozophrenia.

26/08/2004

3343

Sucralfate (7%) + Povidone Iodine (5%)Ointment

Each gm contains; sucralfate-70mg, povidone iodine-50mg

As topical anti infective in conditions like ulcer, wounds, cuts and skin infection.

23/08/2005

3344

Sunitinib malate Capsules 12.5mg/25mg (Additional Indication)

Treatment of Unresectable or Metastatic Well-differentiated Pancreatic Neuroendocrine Tumours with Disease Progression in Adults.

05.05.11

3345

Varenicline (As tartrate) 0.5mg/1mg tablets

Each film coated tablet contains; varenicline tartrate eq.to varenicline-0.5mg, 1mg

As an aid to smoking cessation treatment in adults.

30.05.07

3346

Zolpidem Tartrate E.R tablet (6.25mg/12.5mg).

For insomnia.

10/07/2006

3347

Azithromycin eye drops 1%

Conjunctivitis

06.06.07

3348

Bivaluridin Injection (250mg/vial)

Each vial contains; bivaluridine-250mg

For use as an Anti-coagulant in patients with unstable angina undergoing percutaneous transluminal coronary angiography (PTCA).

25/08/2005

3349

Cinnarizine SR tablets

Each tablet contains; cinnarizine-75mg

02/09/2004

3350

Lidocaine7.5mg + Prilocaine2.5mg per acutation spray

For the treatment of adult male patients with premature ejaculation.

12.03.10

3351

Deferasirox dispersible tablet 125/250/500mg.

Each disp.tablet contains; deferasirox-125mg, 250mg, 500mg

For the treatment of chronic iron overload due to blood transfusion (transfusional haemosiderosis) in patients aged 2 years and above.

12/07/2006

3352

Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension

For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, blotiÞ¡

05.03.10

3353

FDC of beta-carotene + vitamins+minerals

Each cap contains; beta-carotene (30% dispersion, eq.to vit.A 7500IU-15.0mg, vit.E acetate-25.0mg, vit.C-100.0mg, pyridoxine hcl (vit.B6)-1.5mg, cyanocobalamine (vit.B12)-5mcg, folic acid-400mcg, zinc (elemental) as ZnO-15mg, selenium (elemetal) as SeO2-1Þ¡

10/10/2001

3354

Imipenem + cilastatin inj.

Each vial contains; imipenem eq.to anhd.imipenem-250mg,500mg, Cilastatin sod.eq.to cilastatin-250mg,500mg

For the treatemnt of serious lower respiratory/urinary tract infection, intra abdominal, bone & joint infections, endocarditis & bacterial septicemia.

25/07/2003

3355

Isosorbid-5-mononitrate (SR) + aspirin hard gelatin caps.

Each hard gelatin capsule contains; isosorbid-mononitrate (as SR pellets)-60mg, aspirin-75mg

By cardiologists- for prophylaxis of angina and prevention of myocardial infarction.

16-07-2002

3356

Ketoconazole 2% + Zinc Pyrithone 1% Lotion

For the treatment of pityriasis and dandruff of the scalp.

23.02.09

3357

Levetiracetam Oral Solution 100mg/ml (Additional Indication)

As Adjunctive Therapy in the Treatment of Partial Onset Seizures With or Without Secondary Generalisation in Adults, Children and Infants from 1 Month of Age with Epilepsy.

05.05.11

3358

Ramipril 5mg + Hydrochlorthiazide 12.5mg tablets (Additional Strength)

Same as Approved.

20.02.08

3359

Rosiglitazone maleate tablets

Each film coated tablet contains; rosiglitazone maleate eq.to 1mg,2mg,4mg,8mg of rosiglitazone.

By RMP- for treatment of type-II diabetes mellitus as mono therapy & adjunct to diet.

28-06-2000

3360

Ciclesonide Nasal Spray 50mcg/spray

For seasonal & perennial allergic rhinitis in adults, adolescents aged â?¥ 12 years.

08.06.07

3361

Efavirenz Oral Solution (30mg/ml)

Each ml contains; efavirenz-30mg

For the treatment of HIV-1 infection in combination with other anti-retroviral agents in adults & adolescents and children 3 years of age and older who are unable to swallow the hard capsules.

25/08/2005

3362

Esomeprazole Delayed Release Granules for Oral Suspension: Each 1g sachet contains: Esomeprazole Magnesium I.P(as trihydrate) equivalent to Esomeprazole 10 mg as enteric coated granules (Additional Dosage Form).

1) Treatment of Gastroesophageal Reflux Disease (GERD). 2) Risk Reduction of NSAID Associated Gastric Ulcer. 3) H.Pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence. 4) Pathological Hypersecretory Conditions Including Zollinger-Ellison SynÞ¡

13.05.11

3363

Granisetron tabs

Each film coated tablet contains; granisetron hcl eq.to granisetron-1mg,2mg, each ml of inj.contains; granisteron hcl eq.to granisetron-1mg.

By RMP- for nausea vomiting in cancer patients treated with cytotoxic drugs.

05/07/2000

3364

Lamivudine 30mg + Zidovudine 60mg +Nevirapine 50mg Oral Suspension (Tablets for oral Suspension)

For the treatment of HIV patients.

23.02.09

3365

Metformin 1000 mg SR tablets

1000mg

2002

3366

Metronidazole CR tablet 600mg

For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis.

21.02.08

3367

Racecadotril caps

Each cap contains; racecadotril-100mg

For the treatment of acute diarrhoea in adults only.

10/10/2001

3368

Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo

For the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp.

05.03.10

3369

Tirofiban infusion

Each 1 ml inj.contains; tirofiban (as hcl)-0.05mg

By specialists only- in combination with heparin for the treatment of acute coronary syndrommes including patients undergoing PTCA or atherectomy.

12/08/2003

3370

Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet.

For vitamin C deficiency.

12/07/2006

3371

Voriconazole tablets & injection

i)-Each film coated tablet contains; voriconazole-50mg,200mg, ii)-Each vial contains; voriconazole-200mg eq.to 10mg/ml following constitution.

Specialists only- for the treatment of invasive aspergillosis and serious fungal infection caused by seedosporium apiospermum and fusarium spp.including flusarium solani in patients intolerant of or refractory to other therapies. Also amended on 29-10-200Þ¡

08/09/2004

3372

Bendamustine Hydrochloride Injection 100mg/vial (Additional Indication)

For the use in Indolent B-cell NonHodgkin's Lymphoma (NHL) that has Progressed During or Within Six months of Treatment with Rituximab or a Rituximab containing Regimen.

18.05.11

3373

Cefdinir bulk,caps & oral suspension

Each caps contains; cefdinir-300mg, Each 5ml of reconstituted oral suspension contains; cefdinir-125mg

Community acquired pneumonia acute exacerbation of chronic bronchitis, uncomplicated skin & skin structure infection, pharyngitis, tonsilitis. Acute maxillary sinusitis & acute bacterial otitis media-additional

10/10/2001

3374

Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection

Antibiotic

08.06.07

3375

Combikit of lamivudine tabs, efavirenz tab & didanosine delayed release capsules

Combikit of tablets & capsules. 1xefavirenz-600mg, 1xlamivudine-300mg, 1xdidanosine (delayed release)-250mg,400mg

By RMP only- for treatment of HIV infection.

20/09/2004

3376

Didanosine Powder for oral solution (2gm/4gm per bottles)

Anti-AIDS

26/08/2005

3377

Forskolin Eye drop (1%)

For open angle glaucoma.

27/07/2006

3378

Faropenam Sodium Extended Release Tablet 225/300/450 mg

For the Treatment of respiratory tract infections, urinary tract infection, skin and skin structure infections and gynaecological infections.

08.03.10

3379

Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets

As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control.

23.02.09

3380

Lamivudine 40mg + Stavudine 10mg dispersible tablet.

For HIV infection.

12/07/2006

3381

Mefenamic acid + tizanidine

Mefenamic acid-500mg, tizanidine-2mg

By RMP

12/07/2002

3382

Quetiapine fumarate SR tablets

For the additional indication "acute manic episode associated with bipolar disorder".

21.02.08

3383

Raubasine + Almitrine bismesylate

Each film coated tablet contains; almitrine bismesylate-30mg, raubasine-10mg

For RMP- for the corrective treatment of symptoms due to abnormal mental deficiency and age related hypoxia in elderly patients (viz. Cerebral muscular insufficiencies)

11/08/2003

3384

Rituximab (finished formulation import)

Each vial of rituximab-10mg/ml

By cancer specialist-for the treatment of patients with relapsed or chemo resistant indolent B cell non-hodgkins lymphomas.

10/07/2000

3385

Ambroxol + Pseudoephedrine + Chlorpheniramine maleate tabs/suspension/syrup

26/02/1998

3386

Axitinib Tablet 1mg/5mg

Each film coated tablet contains; axitinib-1mg, 5mg

For the â?? treatment of advanced renal cell carcinoma after failure of one prior systemic therapyâ?.

18.09.14

3387

Azabiperidol bulk

Neroleptic agent- Indicated in the treatment of acute & chronic schizophrenia, anxiety, depressive, psychosis & hyperkinetic children.

1981-September

3388

Benziquinone guanyl hydrazone thiosemi carbazone

10 mg

Powerful oral and pharyngeal disinfectant.

1961- March

3389

Bepotastine besilate ophthalmic solution 1.5% w/v

Each ml contains; bepotastine besilate-15.0mg, benzalkonium chloride IP-0.01% w/v (as preservative), sterile aqueous vehicle-q.s

For the treatment of itching associated with allergic conjunctivitis.

08.06.16

3390

Betaxolol ophthalmic solution

Each 5ml vial contains; betaxolol 0.5% w/v (as betaxolol hcl).

Ocular hypertension and chronic open angle glaucoma.

01/05/1992

3391

Biclotymol

Each 100ml syrup contains; biclotymol (adult-0.198g, children-0.150g), glyceryl galacolate (adult-0.200g, children-0.200g), pholocodine (adult-0.133g, children--0.100g), chlorphenamine (adult-0.0133g, children- 0.010g)

Respiratory tract infections, bronchitis, coughs and *tracheobronchitis.

1986-May

3392

Buparvaquone

Buparvaquone solution for injection contains; 5% w/v buparvaquone.

Indicated in the treatment of bovine theileriosis.

1991- April

3393

Carboquone tablet/injection

Each tablet contains; carboquone-0.25mg,0.5mg, Each vial contains; carboquone-1mg

Anti cancer- in the remission of subjectived objective symptoms of encephaloma gastro-intestinal cancer, lung cancer malignant lumphoma & chronic leukaemia.

1985-August

3394

Carisoprodol

Muscle relaxant

1965- March

3395

Chlorphenoxamine hcl

Each tablet contains; chlorphenoxamine hcl-12mg.

1971- March

3396

Clonidine Hcl

Each ml contains; Clonidine Hcl-150mcg

1976-June

3397

Clopidogrel bisulphate

Each film coated tablet contains; clopidogrel bisulphate eq.to clopidogrel-75mg

By RMP- for treament of atherosclerosis events (myocardial infarction, stroke & vascular death)

01/02/2001

3398

Clotrimazole

Each vaginal tablet contains; Clotrimazole-0.1gm

Antifungal & local anti trichomonial agent- Indicated against certain bacteria, protozoa and against certain organism which are sensitive to metronidazole.

1975-June

3399

Darunavir (as ethanolate) Tablet 300mg

Each film coated tablet contains; darunavir (as ethanolate)-300mg

For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100mg ritonavir, anÞ¡

23.03.09

3400

Desonide cream

Desonide cream-0.05%

For relief of the inflammatory and pruritic manifestation of corticosteroid responsive dermatosis.

07/03/1997

3401

Dibenal+allantoin + boric acid+menthol

Dibenal-0.5% w/w, allantoin-0.2% w/w, boric acid-1% w/w, menthol-0.08% v/w

1973-May

3402

Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium 2.00 % w/v + Methyl Salicylate IP 10.00% w/v + Menthol 5.00 % w/v + Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional Strength)

Diclofenac diethylamine BP: 2.32%w/v eq. To diclofenac sodium-2.00% w/v + Methyl salicylate IP-10.0%w/v + Menthol-5.0%w/v + Absoule alcohol IP- 10.00% v/v

For the Treatment of Acute Lower Back Pain.

01.01.13

3403

Diflorasone Diacetate ointment (0.5mg/gm)

Each gm of topical ointment contains; diflorasone diacetate-0.5mg

By dermatologists- For the treatment of inflammatory & pruritic manifestation of corticosteroid responsive dermatoses.

08/02/2005

3404

Dimethylpolysiloxane

Cream tubes of 75 g & jar of 40 g

Prevention of irritation of skin.

1969- May

3405

Omeprazole 20/40mg + Sodium Bicarbonate 600mg + Magnesium Hydroxide 700mg sachet

Additional strength.

19.03.09

3406

Disopyramide

Each capsule contains; Disopyramide-100mg

Anti-arrhythimic agent- indicated in the treatment of cardiac arrhythmias including atrial fibrillation, vent. tachycardia arrhythmia.

1977-June

3407

Disopyramide injection

Each ampoule contains; disopyramide phosphate eq.to 100mg of disopyramide base in 5ml aqueous solution, disopyramide phosphate eq.to 150mg of disopyramide base in 7.5ml aqueous solution.

1983-August

3408

Doxepin hydrochloride

Each tablet/dragee/capsule contains; doxepine hydrochloride-10mg, 25mg & 50mg

1972- September

3409

Eliglustat capsules 84mg

Each capsule contains; Eliglustat 84mg (Eq. To 100mg of eliglustat tartrate or hemitartrate salt)

For the long term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (Ems), intermediate metabolizers (Ims), or poor metabolizers (PMs) as detected by an appropriate test.

31.01.17

3410

Epicillin (6-Aminopenicillanic acid)

Each capsule contains; Epicillin-250mg, 500mg

Antibiotic- For the treatment as respiratory tract, G.I. Tract and genitourinary tract infections.

1974-May

3411

Estradiol + dydrogesterone

Estradiol-2mg, dydrogesterone-10mg

For treatment of women with intact uterus for the symptoms of estrogen deficiency as consequence of the menopause or after overectomy and for the prevention of post menopausal osteoporosis.

01/02/2000

3412

Eszopiclone tablet (1mg/2mg/3mg)

For insomnia

07.02.07

3413

Etoposide injection

Each 5ml ampoule contains; etoposide-100mg, etoposide capsules-50mg(4-11-92)

Anti cancer- Indicated in the treatment of small cell lung cancer, malignant lymphomas, acute leukaemia, testicular tumours etc.

1988-March

3414

Etravirine Tablet 100mg

In combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTÞ¡

26.04.12

3415

Furazolidone + Metronidazole Benzoate + Pectin + Kaolin

Each 5mL contains; Furazolidone-30mg, Metronidazole Benzoate-100mg, Pectin, Kaolin.

1979-March

3416

Lincomycin + Neomycin + Methyl prednisolone

Each 10ml contains; lincomycin hcl monohydrate eq.to 200mg base, neomycin sulphate eq.to 200mg base, methyl prednisolone-5mg

1989-March

3417

Lomefloxacin tablet

Each tablet contains; lomefloxacin-400mg

In the treatment of mild to moderate infections caused by susceptible starins of designated micro-organism in RTI uncomplicated and complicated UTI.

20/05/1994

3418

Moxifloxacin Eye Ointment (5mg/gm)

For ophthalmic use.

06/02/2006

3419

Nafarelin acetate

Each 1ml nasal spray contains; nafarelin (as base)-2mg

Endometriosis and central precarious puberty only (for gynaecologist only)

17-03-1999

3420

Nanocrystalline Silver Gel 0.002%

For the treatment of burns and wound infections.

04.01.08

3421

Norethisterone 2mg & Mestranol 0.1 mg

Oral contraceptive

1967- April

3422

Norfloxacin

Eye drop/ear drop/eye oint.-0.3%

1990- February

3423

Quinethazone

50 mg tabs

Diuretic (oral)

1964- January

3424

Rofecoxib inj.

Each ml contains; rofecoxib-12.5mg

For short term treatment of acute post-operative pain in adults only.

11/02/2003

3425

Rosaxacin

Each capsule contains; rosoxacin-150mg

Oral anti-gonococcal agent- Indicated in the treatment of gonorrheal urethritis

1982-July

3426

Salbutamol Sulphate

Each Sustained release tablet contains; Salbutamol Sulphate B.P Eq to 8mg of Salbutamol

1980-March

3427

Secnidazole tablet

Each tablet contains; secnidazole-500mg, Each film coated tablet contains; secnidazole-1gm(20-5-94), Each 15ml suspension contains; secnidazole-500mg(19-2-98)

Intestinal amoebiasis, amoebic hepatitis, trichomonial vaginitis, bacterial vaginitis and giardiasis.

13/05/1993

3428

Sertraline

50mg, 100mg

For additional indication

12/02/2004

3429

Streptokinase-streptodornase

Anti-inflammatory.

1963- April

3430

Sulbutiamine tabs

Each sugar coated tabs contains; sulbutiamine-200mg

Symptomatic treatment of functional asthenia.

22/04/1996

3431

Sulfametopyrazine + Pyrimethamine

Each tablet contains; Sulfametopyrazine-500mg, Pyrimethamine-25mg

1978-May

3432

Sulpha-dimethyl oxazole (Sulfamoxole)

1-2 g per day

Intermediate acting sulpha drug.

1962- March

3433

Sulprostone injection

Each ampoule contains; sulprostone-500mcg

To be made available to MTP centres approved by the states not below district level.

1987-February

3434

Tapentadol Hydrochloride Tablets 50mg/75mg/100mg

Each film coated tablet contains; tapentadol hydrochloride eq.to tapentadol-50mg, 75mg, 100mg

For relief of moderate to severe acute pain in adults 18 years of age or older.

18.04.11

3435

Teneligliptin Hydrobromide Hydrate 20mg

Each film coated tablet contains; tenegliptin hydrochloride hydrate eq.to tenegliptin-20mg

"For the treatment of type 2 Diabetes Mellitus as a monotherapy adjunct to diet and Exercise."

18.05.15

3436

Tetramisole hydrochloride

Each tablet contains; tetramisole hcl-50mg, 150mg

Anthelmintic

1970- May

3437

Thiabendazole

1968- July

3438

Tofisopam uncoated tablet JP... 50/100mg

Each uncoated tablet contains; tofisopam JP-50mg, 100mg

For the treatment of anxiety and depression.

16.04.10

3439

Tromantadine hcl ointment

Tromantadine hcl-1gm, gel base ad-100gm

Herpes simplex infection of the skin.

23/02/1995

3440

Zaleplon cap & bulk

Each cap contains; zaleplon-5mg,10mg

For short term treatment of insomnia

17-01-2002

3441

Abacavir sulphate oral solution

Each 1ml oral solution contains; abacavir (as sulphate)-20mg

By RMP only- for the treatment of HIV infection in combination with other anti retroviral drugs.

20/09/2004

3442

Aceclofenac 100mg + Tizanidine 2mg film coated tablets

For the treatment of acute low back pain in adult patients only.

23.02.09

3443

Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength)

For the treatment of hypertension only.

10.03,10

3444

Atorvastatin Calcium 80mg tablets (Additional Strength)

Additional Strength (it should not be used routinely because of increased risk of adverse events. It should be reserved for patients who are considered to be at higher risk after careful risk assessment).

25.02.08

3445

FDC of Loperamide + simethicone tab

Each chewable tab contain; loperamide hcl-2mg, simethicone-125mg

For control of acute diarrhoea in adults only.

16-10-2001

3446

Fondaparinux sodium

Each pre filled syringe of subcutaneous injection contains; fondaparinux sod.-2.5mg/0.5ml

Specialist

2003

3447

Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspension

For Post-Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists.

19.05.11

3448

Isotretinoin 0.05% + Erythromycin 2% gel

For acne

08.06.07

3449

Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup

For productive cough.

20/07/2006

3450

Pygeum africanum soft gelatin caps & bulk import

Each cap.contains; pygeum africanum extract-50mg

Benign prostate hypertrophy

30-07-2002

3451

Sodium Valproate (750mg/1000mg) C.R. Tablet

Addl.Strength

26/08/2005

3452

Trastuzumab powder concentrate infusion

Each vial contains; trastuzumab-440mg

By cancer specialist-in metastatic breast cancer who have tumours that over express human epidermal growth factor receptor-2 (HER2)

10/07/2000

3453

Aliskiren Tablet 150mg/300mg

For hypertension

08.06.07

3454

Cefepime injection

Each vial contains; cefepime-250mg

For the treatment of LRTI & UTI, skin & skin structure infection.

2004-September

3455

Cefixime 200mg + Pot. Clavulanate (125mg) tablet

Anti-biotic

20/07/2006

3456

Clonazepam tabs.

Additional indication of panic disorder.

17-10-2001

3457

Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules

19.05.11

3458

Dorzolamide (as hcl) 20mg opthalmic solution (bulk+formulation)

Each ml contains; dorzolamide (as hcl)-20mg

Ophthalmologists- for the treatment of elevated intraocular pressure in patients with ocular hypertension on open angle glaucoma.

03/10/2003

3459

Doxofylline MR Tablet 650 mg

For the treatment of Bronchial Asthma and COPD in Adults.

11.03.10

3460

Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tablet

For the treatment of haemorrhoid.

29.02.08

3461

Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotion

As sunscreen lotion for prevention of sunburn skin.

23.02.09

3462

Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet

Each bilayered SR tablet contains; oxcarbazepine-150mg, 300mg, 600mg

For the treatment of partial seizures in adults with epilepsy as monotherapy or adjunctive therapy.

08/09/2005

3463

Salmon calcitonin nasal spray

Each metered dose delivers; synthetic salmon calcitonin-50IU,100IU,200IU

By RMP- in post menopausal osteoporosis, bone pain associated with osteolysis and/or osteopenia paget's disease.

18-07-2000

3464

Sirolimus oral soln.

Each ml of soln.contains; sirolimus-1mg/ml

Prophylaxis of organ rejection in patients receiving renal transplants.

13-07-2002

3465

Acitretin

Each hard gelatin capsule contains; acitretin-10mg, 25mg

For the treatment of severe psoriasis in adults patients (excluding female of child bearing potentials) with 7 points of warning

09/09/2005

3466

Amtolmetin Guacil tablets 600mg

For the treatment of osteoarthritis & rheumatoid arthritis.

07.03.08

3467

Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup

For the symptomatic relief of productive cough associated with allergic rhinitis, when both antihistamine and mucolytic agents are desired.

23.02.09

3468

Drotrecogin alpha (activated)

Each vial contains; drotrecogin alpha (activated) lyophilized-5mg,20mg

For reduction of mortality in adult patients with severe sepsis.

23-07-2002

3469

Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength)

As approved

08.06.07

3470

Iobitridol soln for inj.

Each ml contains; iobitridol corresponding to 250mg, 300mg, 350mg of iodine.

For patients undergoing i.v urography, barin & whole body CT, digital substraction angiography of aorta & lower limbs & angio cardiography.

17-10-2001

3471

ISMN SR 30mg + Aspirin75/150mg tablet (addl. Strength).

Same as approved.

20/07/2006

3472

Oxandrolone Tablet (2.5/10mg)

To promote weight gain.

04/08/2006

3473

Latanoprost 50mcg/ml Ophtalamic Solution (Additional Indication)

For the Reduction of Elevated Intraocular Pressure in Paediatric Patients with Elevated Intraocular Pressure and Paediatric Glaucoma.

02.06.11

3474

Meropenem Injection IP 500mg/1.0g (Additional Indication)

For Treatment, in Children, of the following Infections Caused by Single or Multiple Bacteria Sensitive to Meropenem: Pneumonias and Nosocomial Pneumonias, Urinary Tract Infections, Intra-abdominal Infections, Gynaecological Infections Such as EndometriatÞ¡

20.05.11

3475

Rosiglitazone tablets

Each tablet contains; rosiglitazone-2mg,4mg,8mg

For additional indication of "in combination with suphonyl urea or metformin when diet,exercise and rosiglitazone alone or diet, exercise plus the single agent do not results in adequate glycemic control".

14-07-2000

3476

Trandolapril tablets (bulk+ formulation)

Each tablet contains; trandolapril-1mg,2mg,4mg

RMP only- for the treatment of mild to moderate hypertension.

03/10/2003

3477

Valdecoxib + Paracetamol

Valdecoxib-20mg, paracetamol-500mg

RMP- for treatment of acute pain in adults only.

20/09/2004

3478

Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.005%) (additional strength)

For lowering of IOP in patients with open angle glaucoma occular hypertension.

07.03.08

3479

Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for children)

As approved

08.06.07

3480

Clarithromycin M.R tabs

Each modified release tab contains; clarithromycin-500mg

Lower respiratory tract infection, upper respiratory tract infection & skin & soft tissue infections.

16-10-2001

3481

Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment

For plaque psoriasis.

20/07/2006

3482

Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule (Additional Strength)

Same as approved

31.05.11

3483

Dried Ivy Leaf Extract (0.7gm/100ml) cough syrup

Each 100ml solution contains; active agent dried ivy leaf extract-0.7gm

For the treatment of acute inflammation of respiratory tract accompanies by coughing & symptomatic treatment of chronic inflammatory bronchitis in adults.

15/09/2005

3484

Fenoverine cap. (bulk+formulation)

Each capsule contains; fenoverine-100mg

RMP- for the treatment of smooth muscle spasm of gastro intestinal tract & IBS.

08/10/2003

3485

"Hyperox" peracetic acid + hydrogen peroxide liquid

Composition; peracetic acid, hydrogen peroxide (NLT 24.0%), peracetic acid (NLT 4.5%)

Disinfections of farms for livestock species.

2004-September

3486

Insulin lispro mixtures (rDNA) inj.

Already approved for different mixtures, diabetes mellitus.

31-07-2000

3487

Lidocaine Lozenges 200/300mg

For single agent anesthesia in upper gastro intestinal endoscopy.

26.02.09

3488

Methotrexate 0.25% topical gel

Each gm contains; methotrexate IP 0.25% w/w in hydroxy gel base.

Topical treatment of psoriasis.

21-08-2002

3489

Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg

For the treatment of the sign and symptoms of idiopathic parkinsons disease.

13.03.10

3490

Amlodipine 10mg/10mg + Telmisartan 40mg/80mg Tablets (Additional Strength)

Same as approved

31.05.11

3491

Calamine 8% + Liquid Paraffin10% lotion

As antipruritic and smoothening agent.

26.02.09

3492

Combikit of oxymetazoline & NaCl soln.

Each combikit contains; oxymetazoline 0.05%-10ml, NaCl soln 2%-15ml

Symptomatic relief of nasal mucosal congestion & adjunctive therapy of middle ear infection associated with acute/chronic rhinitis, common cold, sinusitis.

12/10/2001

3493

Dexrabeprazole sodium Enteric Coated tablet 5mg/10mg

Each entric coated tablet contains; dexrabeprazole sodium-5mg, 10mg

For the treatment of gastric ulcer, duodenal ulcer, & GERD.

13.06.07

3494

Drosperinone 3mg + Ethinyl Estradiol 0.02mg tablets

For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication).

16.03.10

3495

Latanoprost + timolol maleate eye drops

Each ml contains; latanoprost-50mcg, timolol maleate eq.to timolol-50mg (5.0mg ??)

Reduction of intraocular pressure in patients with open angle glaucoma & ocular hypertension.

02/08/2002

3496

Methoxsalen USP-20mg Tablet

1) For repigmentation of idiopathic vitiligo alongwith phototherapy. 2) For symptomatic control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy.

07.03.08

3497

Moclobemide film coated tablets, bulk

Tablets of moclobemide-150mg,300mg

By psychiatrist- major depression & social phobia.

28-07-2000

3498

Modafinil tablets & bulk

Each tablet contains; modafinil-100mg,200mg

By neurologists/psychiatrists/specialists only- to improve wakefulness in patients with excessive day time sleepiness associated with narcolepsy.

16/12/2003

3499

Nimesulide 1% + Methyl Salicylate 5%

Each container contains; nimesulide BP-1.0%(w/w), methyl salicylate IP-5.0%(w/w)

For local application in relieving pain in acute low bachache, tendonitis, tenosinovitis & spasm.

20/09/2005

3500

Oxcarbazepine tablets

2004-September

3501

Sodium Hyaluronate Injection (1%)

For OA.

26/07/2006

3502

Amphotericin B emulsion injection

Each ml of the emulsion contains; amphotericin B IP-5mg

Indicated for the treatment of visceral leishmaniasis.

29/08/2003

3503

Cefditoren pivoxil 400mg tablets (Additional Strength)

Same as Approved.

11.03.08

3504

Cefuroxime axetil extended release tablets

Each ER tablet contains; cefuroxime axetil eq.to cefuroxime-500mg,1000mg

2004-October

3505

Desogestrel tab

Each film coated tab contains; desogestrel-0.075mg

Oral contraception in women only

20-08-2002

3506

Feracrylum (1%) + Metronidazole (1%)

Each gm of gel contains; feracrylum-1%, metronidazole-1%

An antiseptic gel for topical application.

05/10/2005

3507

Levonorgestrel releasing intrauterine system

Each sterile IUS contains; levonorgestrel-52mg

By RMP- contraception, menorrhagia & endometrial hyperplasia during estrogen replacement therapy in women.

13-09-2000

3508

Miglitol 25 mg + Metformin 500mg tablets

Additional Strength

16.03.10

3509

Nifedipine 0.3% + Lidocaine1.5% cream

For the treatment of anal fissures.

26.02.09

3510

Renolazine Extend Release tablet (500mg)

For Chronic Angina.

14.06.07

3511

Rofecoxib gel

Each gm of gel contains; rofecoxib-10mg

For acute musculo skeletal pain in adults.

18/10/2001

3512

Baclofen E.R capsule (30mg)

Each ER capsule contains; Baclofen USP 30mg

For the symptomatic treatment of neuronal spasticity due to multiple sclerosis, spinal chord, pathology & injury.

01/08/2006

3513

Botulinum toxin type A 50 Units/Vial and 100 Units/Vial (Additional Indication)

For the prophylaxis of headaches in adults with chronic migraine.

02.06.11

3514

Doxofylline ER tablets 400mg/800mg (addl. Strength)

For the treatment of bronchial asthma & COPD in adults.

12.03.08

3515

Exemestane tab

Each tab contains; exemestane-25mg

For Treatment of advanced breast cancer in post menopausal women whose disease has progressed following Tamoxifen therapy.

18-10-2001

3516

FDC of Methylcobalamin (1500 mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet

Each tablet contains; methylcobalamine(ER)-1500mcg, pyridoxine Hcl(IR)-20mg, Folic acid(IR)-5mg

For the management of hyper-homocysteinemia.

19/09/2005

3517

Iomeprol inj.

Each ml contains; iomeprol corresponding to 300mg,400mg iodine.

For use in hospitals, nursing home, institution only. For use in intravenous urography C/T (Brain & Body)

05/10/2000

3518

Nimesulide IM injection

Each ml contains; nimesulide-100mg

For the treatment of pyrexia and inflammatory conditions in live stock.

11/10/2004

3519

Phenytoin sodium ER capsules (300mg) (New dosage form)

Each ER capsule contains; phenytoin sodium-300mg

For the control of generalized tonic-clonic (grand mal) and complex partial seizures and prevention & treatment of seizures occurring during or following neurosurgery.

13.06.07

3520

Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules

For the prophylaxis of migraine.

16.03.10

3521

Quinapril 20mg + Hydrochlorthiazide 25mg film coated tablet

For the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion.

26.02.09

3522

S-amlodipine tab/bulk

Each uncoated tab contains s-amlodipine besilate eq.to s-amlodipine-2.5mg

Essential hypertension and angina pectoris.

16-08-2002

3523

Tadalafil 10mg/20mg Tablets

Each film coated tablet contains; Tadalafil 10mg/20mg

For the treatment of erectile dysfunction in adult men.

11/09/2003

3524

Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet

For BPH in men with enlarged prostate.

14.06.07

3525

Amisulpiride Tablet (50/100/200mg)

For schizophrenic disorder.

01/08/2006

3526

Betamethasone 0.05% + Miconazole 2% Cream

For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin.

12.03.08

3527

Capecitabine tablets (finished formulation import)

Each film coated tablet contains; capecitabine-150mg,500mg

By cancer specialists- for treatment of metastatic breast cancer after failure of paclitaxel and anthracycline containing chemotherapy regimen.

12/10/2000

3528

Citicholine 500mg + Piracetam 400mg Tablets

For the treatment of acute stroke.

16.03.10

3529

Clostridium Botulinum Toxin Type-A Injection 100Units/Vial (Additional Indication)

For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy.

03.06.11

3530

Decapeptide lotion (basic fibroplast growth factor)

Each glass bottle contains; basic fibroplast growth factor-2mg

Treatment of vitiligo/white patches in adults.

22-10-2001

3531

Gatifloxacin eye ointment (0.3%)

Each gm of ointment contains; gatifloxacin-3mg

Ophthalmologists only- for the treatment of external bacterial infections of eyes.

15/10/2004

3532

Ketorolac Tromethamine 0.4% Eye drops (addl.Strength)

Ophthalmic.

20/09/2005

3533

Levodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving tablet

For the symptomatic symptoms of idiopathic Parkinson's Disease.

04.03.09

3534

Perindopril erbumine tablets

Each tablet contains; perindopril tert-butyl amine/erbumine-8mg

For the treatment of arterial hypertension.

15.07.2003

3535

Thalidomide caps

Each cap contains thalidomide USP-50mg,100mg

For acute treatment of the cutaneous manifestation of moderate to severe erythema nodosum loprosum and for the treatment of multiple myeloma.

12/08/2002

3536

Cefepime injection 500mg/1gm/2gm (For additional indication)

For bacterial meningitis in children.

14.06.07

3537

Desloratadine bulk & tabs.

Each tab contains (film coated); desloratadine-5mg

Seasonal allergic rhinitis in adults.

30-10-2001

3538

Diclofenac 50mg + Chlorzoxazone500mg Tablets

For the treatment of acute inflammation conditions associated with spasm in adults only.

16.03.10

3539

Diclofenac transdermal patch

Each 70 sq.cm patch contains; diclofenac diethylamine-200mg

By RMP- for the treatment of mild to moderate pain due to OA & soft tissue injuries.

2004-October

3540

Donepezil Sustained Release Tablet 23mg (Modified Dosage Form)

For the Treatment of Mild to Moderate Severe Alzheimer's Dementia.

03.06.11

3541

Levetiracetam Oral Solution (100mg/ml)

Each 1ml solution contains; leveiracetam-100mg

As adjuvant therapy in treatment of partial onset seizures in adults with epilepsy when oral tablets cannot be swallowed by patients.

04/10/2005

3542

Paliperidone ER Tablets 1.5mg

Additional strength.

04.03.09

3543

Pergolide tablets

Each tablet contains; pergolide mesylate eq.to pergolide base-50mcg,250mcg,1000mcg

By neurologists- adjunctive treatment to levodopa in management of the signs & symptoms of parkinson's diasease.

11/10/2000

3544

Premetrxed disodium injection 100mg/vial (Additional Strength)

Same as Approved.

12.03.08

3545

Quetiapine S.R tablet 200/300mg

Each oral SR tablet contains; Quetiapine fumarate eq. to quetiapine 200mg/300mg

For the management of manifestation of psychotic disorders (Schizophrenia).

01/08/2006

3546

Sirolimus tablets 2mg

Each tablet contains; sirolimus-2mg

The prophylaxis of organ rejection in patients receiving renal transplant alongwithh the regmens of cyclosporines and corticosteroids.

01.12.2003

3547

Tilmicosin aqu.conc. Liquid

Each ml of aq.conc.liquid contains; tilmicosin-250mg

In treatment of chronic respiratory diseases in poultry

23-08-2002

3548

Cabergoline tab

Each tab (uncoated) contains; cabergoline-0.5mg

For hyperprolactinemia, inhibition of lactation & suppression of lactation.

05/09/2002

3549

Ceftiofur sod. Inj.

Each vial contains; ceftiofur sodium sterile powder for injecion-500mg

Additional lower strength.

12/10/2004

3550

Daclizumab solution for infusion (finished formulation, import)

Each vial contains; daclizumab-25mg/5ml

By hospital, nursing homes, institution only. For prophylaxis in acute organ rejection in patients receiving transplants.

12/10/2000

3551

Losartan 100mg + Hydrochlorthiazide 25 mg tablet

Additional higher strength.

16.03.09

3552

Lumiracoxib Tablet (100/200/400mg)

For OA, RA acute pain & primary dysmenorrhoea.

01/08/2006

3553

Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets

For the treatment of diabetic neuropathy in adults.

16.03.10

3554

Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension

For gastric ulcer, duodenal ulcer, and GERD.

12.03.08

3555

Progesterone pessary

Each pessary contains; progesterone B.P-100mg,200mg,400mg

Supplementation of insufficient secretion of progesterone in women participating in fertilisation programme.

25-10-2001

3556

Rifaximin Oral Suspension 100mg/5ml (New Dosage Form)

Each 5ml suspension contains; Rifaximin 100mg

Treatment of Infectious Diarrhoea in Adult and Children(>2years of age and above).

09.06.11

3557

Tazarotene

Anti acne.

12.09.2003

3558

Tranexamic acid mouthwash (50mg/ml)

Each ml contains; tranexamic acid-50mg

For the prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery.

15.06.07

3559

Zinc (Gluconate) oral solution (20mg/5ml)

Each 5ml contains; zinc gluconate USP eq.to elemental zinc-20mg

For the treatment of acute diarrhoea in children as an adjunct to oral rehydration.

10/10/2005

3560

Allyloestrenol

5mg tab

Progestational compound

1964- January

3561

Aminosidine Sulphate

Each vial contains; Ammosidine sulphate-500mg

Antibiotic- indicated in the treatment of staphylococcus sepsis, infection of the respiratory tract due to staphylococcus and pneumococcus, infections of the urinary tract due to E.coli, P.vulgaris, Gonococci infection resistant to other antibiotics.

1976-June

3562

Amlodipine besylate tablets

Each tablet contains; amlodipine besylate eq.to active amlodipine besylate-5mg,10mg,2.5mg(8-11-94, TPL)

Indicated in hypertension, angina pectoris.

19/05/1993

3563

Amlodipine + Lisinopril tabs

Each tab contains; amlodipine besylate eq.to amlodipine-5mg,2.5mg, lisinopril eq.to lisinopril anhydrous-5mg,2.5mg

Mild to moderate hypertension.

27/03/1997

3564

Amoxycillin + Clavulanic acid tablets

Each tablet contains; potassium clavulanate eq.to 125mg of clavulanic acid, amoxycillin trihydrate eq.to 250mg, 500mg, 875mg(27-1-99) of amoxycillin

1987-February

3565

Azithromycin caps/suspension/inj.

i)-Each capsule contains; azithromycin dihydrate eq.to 250mg of base, ii)-Each 5ml contains; azithromycin-200mg,50mg

For susceptible infections including community acquired pneumonia pelvic inflammatory disease.

13/05/1994

3566

Benazepril hcl tabs

Each tab contains; benazepril hcl-5mg,10mg,20mg

Essential hypertension and congestive heart failure.

22/04/1996

3567

Calcium polystyrene sulphonate

Each container contains; calcium polystyrene sulphonate-300gm

By RMP- for treatment hyperkalemia associated with oligurea, anurea or dialysis.

05/02/2001

3568

Centbucridine Bulk/Injection

Centbucridine-0.5%

For the purpose of infiltration or regional block anethesia and for dental surgery only.

1985-August

3569

Ropivacaine HCl Inj. 2mg/5mg/7.5mg/10mg

Each ml contains; ropivacaine Hcl USP-2mg, 5mg, 7.5mg, 10mg

For the production of local or regional anasthesia for surgery and for acute pain management.

20.03.09

3570

Ceritinib Hard gelatin Capsule150 mg

Each hard gelatin capsule contains; ceritinib-150mg

For the treatment of patients withÂ anaplasticÂ lymphomaÂ kinaseÂ (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who haveÂ progressed on or are intolerant toÂ crizotinib.

03.07.15

3571

Chlorzoxazone

250 mg tabs

Muscle relaxant.

1963- April

3572

Cimetidine

Each tablet/capsule contains; Cimetidine 200mg, Syrup-Each 5mL contain cimetidine-200mg

1980-June

3573

Cinitapride (as hydrogen tartrate) 1mg tablet

For the treatment of gastroesophageal reflux disease and functional inconveniences of the gastrointestinal motility.

04.01.08

3574

Clotrimazole

Each 100gm contains/100mL contains Clotrimazole-1gm

1975-June

3575

Desogestrel + Ethinyloestradiol tablets

Each tablet contains; desogestrel-0.1mg, ethinyloestradiol-0.03mg

1983-November

3576

Dexibuprofen Tablet (200mg/300mg/400mg)

For OA, RA & ankylosing spondylitis.

06/02/2006

3577

Diltiazem Hcl. 2% gel

Each gm of gel contains; diltiazem HCl IP-20mg

For the treatment of anal fissure.

08.02.07

3578

Dinoprost injection

Each ml contains; dinoprost-5mg

1986-May

3579

Diphenoxylate Hcl.

1969- May

3580

Divalproex sodium tab

Each enteric coated tab contains; divalproex sodium eq.to valproic acid-125mg,250mg,500mg

As monotherapy or adjunctive therapy in the treatment of patients with complex partial seizure and manic episodes associated with bipolar disorder.

17-01-2002

3581

Epsilon amino caproic acid

Each ml contains; epsilon caproic acid-250 mg/ml

1971- March

3582

Erythromycin

300mg/6ml

For treatment of mastilis in lactating cows only.

07/02/2000

3583

Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) in smooth transparent ring

Each contraceptive(1.87g/unit) vaginal ring contains; etonogestrel-11.7mg, ethinylestradiol-2.7mg

For Contraceptive in women only.

15/02/2005

3584

Ferrous ethylene diamine tetra acetate trihydrate

25-50 mg

Oral iron compound (chelate form).

1962- March

3585

Flupenthixol Decanoate

Each mL contains; Flupenthixol Decanoate-20mg

1977-July

3586

Furosemide

Oral diuretic

1965- April

3587

Gadopentetate dimegluminate inj.

Each ml contains; 469.01mg gadopentetic acid, dimeglumine salt in aqueous solution.

Contrast media- Cranial and spinal magnetic resonance tomography.

06/05/1992

3588

Ibutilide fumarate injection 0.1mg/ml

Each ml contains; ibutilide fumarate-0.1mg (eq.to ibutilide free base 0.087mg)

For the rapid converion of artirial fibrillation or artrial flutter of recent onset to sinus rhythm. Patients with artrial arrhythmias of longer duration are less likely to respond to Ibutilide fumarate injection. The effectivess of ibutilide has not beenÞ¡

10.06.16

3589

Ifosfamide

Each vial contains; Ifosfamide-200mg, 500mg & 1gm

To be supplied only against demand from hospitals/ cancer institutions for their use and against prescription of cancer specialists

1979-March

3590

Kitotifen fumerate

Each tablet contains; kitotifen fumerate eq.to -1mg base, Each 5ml syrup contains; kitotifen fumerate eq.to-1mg, Ketotifen nasal drop*

Anti asthmatic drug- Indicated in prophylactic treatment of bronchial asthma, symptomatic improvement of allergic conditions including rhinitis and conjunctivitis.

1991- May

3591

Lidocaine 2% + prilocaine 2.5% w/w cream

Lidocaine-2% w/w, prilocaine-2.5%w/w

As a topical anaesthetic for use on normal intact skin for local anaesthetic

1999-May

3592

Lincomycin Hcl.

500 mg tablets

Antibiotic infections caused by gram +ve organism which are sensitive to its actio.

1968- August

3593

Megestrol acetate 4mg & Ethinyloestradiol 0.05 mg

20 tabs

Oral contraceptive

1967- April

3594

Melatonin tablets

Each tab contains; melatonin-3mg

For sleep disorders Jet lag and regulation of circadium rhytham disorders.

12/03/1998

3595

Metoprolol tartrate bulk drug

1982-september

3596

Metronidazole

250mg-oral, 500mg-vaginal

Trichomonal infestatious.

1961- March

3597

Miconazole Nitrate

Each vaginal pessary contains; Miconazole Nitrate-100mg

1978-June

3598

Mitoxantrone injection

Each ml contains; mitoxantrone hcl eq.to 2mg of mitoxantrone

Anti cancer- Indicated in the treatment of acute non-lymphotic leukaemia, breast cancer, non-hodgkins lymphoma.

1989-March

3599

Permethrin cream 5%

Each (30gm tube contains) gm contains; permethrin-(50mg) 5%

Infestation with sarcopyto scabies.

06/03/1995

3600

Propranalol Hcl.

Each tablet contains; propranolol hcl-10mg, 40mg, Each ml-1mg/ml

1972- October

3601

Ramipril + S(-) amlodipine tab

Each tab/cap contains; ramipril-2.5mg, S(-) amlodipine besylate eq.to S(-) amlodipine-2.5mg

For treatment of essential hypertension.

11/02/2003

3602

S(-) amlodipine + Atorvastatin

Each uncoated tablet contains; s(-) amlodipine besylate eq.to s(-) amlodipine-2.5mg, atorvastatin calcium eq.to atorvastatin-10mg

By RMP- for the treatment of coexisting essential hypertension and hyperlipidaemia in adults.

10/02/2004

3603

S-Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per ml

For surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block.

28.04.11

3604

Silver sulphadiazine ophthalmic ointment

Silver sulphadiazide-1%

1988-April

3605

Sodium chloride+ Potassium chloride+ Magnesium chloride+Calcium chloride dihydrate+20/6molar sodium lactate+ Dextrose anhydrous

Each 100mL contain Sodium chloride-558mg, Potassium chloride-14.9mg, Magnesium chloride-10.16mg, Calcium chloride dihydrate-21.9mg, 20/6molar sodium lactate-1.34ml, Dextrose anhydrous-1.5gm

1973-May

3606

Sodium Fusidate

Each gm contains; Sodium Fusidate-20mg, application 3 times daily

Antibiotic- for the treatment of staphylococcal infections such as abscesses boils, carbuncles, varicose ulcer,eczema.

1974-May

3607

Sodium valproate

Antiepileptic drug

1981-October

3608

Telmisartan 20mg + Amlodipine Besylate Eq. to Amlodipine 2.5mg + Hydrochlorothizide 6.25mg Tablets (Additional Strength)

For the Treatment of Essential Hypertension.

03.01.13

3609

Ticagrelor Tablet 90mg

For the prevention of thrombiotic events (cardiovascular death, myocardial infarction and stroke) in patients with Acute coronary syndromes (ACS) unstable angina, non ST elevation Myocardial infarction (STEMI) including patients managed medically, and thoÞ¡

03.05.12

3610

Tinidazole infusion

Tinidazole i.v infusion-2mg/ml in 400ml infusion bottle, 2mg/ml in 800ml infusion bottle.

In the treatment of anaerobic infections.

1990- February

3611

Trimethoprim + sulmethoxazole

i)-Each tablet contains; Trimethoprim-80mg, Sulphamethoxazole-400 mg, ii)-Paediatric tablet-each tablet contains; Trimethoprim-20mg and Sulphamethoxazole-100 mg, iii)-Suspension-each 5ml contains; Trimethoprim-40mg and Sulphamethoxazole-200 mg

Chemotherapeutic agent

1970- July

3612

Ulinastatin Injection 50,000 IU/1,00,000 IU

Each vial contains; ulinastatin J.P-50,000 IU, 1,00,000 IU

For the treatment of mild to severe acute pancreatitis.

19.09.14

3613

Zotepine tablet

Each film coated tablet contains; zotepine-25mg, 50mg, 100mg

For the treatment of schizophrenia

16.04.10

3614

1. PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii 2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5Þ¡

For the treatment of rotavirus diarrhoea.

09.06.11

3615

Amlodipine + Ramipril tablets

Each hard gelatin capsule contains; amlodipine-5mg, ramipril-2.5mg

04/10/2004

3616

Atorvastatin

Each film coated tablet contains; atorvastatin-5mg

As an adjunct to diet to reduce elevated total cholestrol & triglyceride level in patients with primary hypercholesterolemia & mixed dysbetalipoprotenimia (Type IIa & IIb)

30/10/2001

3617

Deflazocort oral suspension (6mg/5ml) (new Dosage Form)

As approved

15.06.07

3618

Etoricoxib 1%+ Menthol 5% Spray

For the topical treatment of acute musculoskeletal pain.

16.03.10

3619

Mecobalamin 1000mcg + Alpha Lipoic Acid 200mg + vitamin B6 3mg + Folic Acid 1.5mg + Inositol 100mg + Benfotiamine 100mg capsule

For the treatment of diabetic neuropathy.

19.03.08

3620

Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion

A sunscreen lotion for prevention of sunburn skin.

19.03.09

3621

Oetylonium bromide

Each tablet contains; otilonium bromide-40mg +bulk import

By RMP- in treatment of irritable bowel syndrome, painful spastic condition of distal enteric tract.

15-12-2000

3622

Risedronate Sodium

For osteoporosis.

17.10.2003

3623

Sodium ferric gluconate complex in sucrose inj & bulk import

Each ml contains; sod,ferric gluconate complex with sucrose eq.to elemental iron-62.5mg (12.5mg/ml)

Treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

05/09/2002

3624

Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet

Each film coated tablet contains; efavirenz-600mg, emtricitabine-200mg, tenofovir disoproxil fumerate-300mg

For the treatment of HIV-1 infection in adults only.

01/08/2006

3625

Trimebutine Maleate

Each coated tablet contains; trimbutine maleate eq.to trimebutin-100mg, 200mg

For the treatment of relief of symptoms associated with irritable bowel syndrome.

10/10/2005

3626

Beclomethasone dipropionate inhaler

Each canister contains; beclomethasone dipropionate-50mcg,100mcg,250mcg

By RMP- for treatment of asthma.

21-12-2000

3627

Butorphanol tartrate inj. & bulk import

Each ml contains; butorphanol tartrate USP-1mg, 2mg

Management of pain where use of opiod analgesics is appropriate

11/09/2002

3628

Enalapril (2.5mg/5mg) + Hydrochlorthiazide (12.5mg) Tablet (Addl.Strength)

Enalapril-2.5mg, 5.0mg, Hydrochlorthiazide-12.5mg in each uncoated tablets

For the treatment of patients with hypertension who are not adequately controlled on monotherapy.

24/10/2005

3629

ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength)

Same as Approved.

19.03.08

3630

Levocetrizine 2HCl syrup

Each 5ml of liquid syrup contains; levocetrizine 2HCl-2.5mg

By RMP

2004-October

3631

Misoprostol

Each tablet contains; misoprostol-100mcg

31/10/2001

3632

Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules

For the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD).

17.03.10

3633

Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets

Additional indication. (For Symptomatic Treatment of Moderate To Severe Pain.)

21.06.11

3634

Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet

For BPH with overactive bladder.

15.06.07

3635

Valgancyclovir

For CMV.

20.11.2003

3636

Ambroxol 30mg + Levosalbutamol 1mg + Guiphenesin 50mg /5ml syrup

For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis.

19.03.09

3637

Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules

Additional higher strength

17.03.10

3638

Eperisone Hydrochloride Sustained Release Capsule 75mg/150mg (Modified Dosage Form)

For Improvement of Myotonic Conditions caused by Neck-Shoulder Arm Syndrome, Scapulohumeral Periarthritis and Low Back Pain.

24.06.11

3639

Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup

Each 5ml contains; erdosteine-150mg, guaifenesin IP-50mg, terbutaline sulphate IP-1.25mg

For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis.

08/08/2006

3640

Gemtuzumab ozogamicin inj.

Each vial contains; gemtuzumab ozogamicin (lyophilized powder)-5mg

Treatment of acute myeloid leukemia

12/09/2002

3641

isotretinoin topical gel (0.05% w/w)

Each gm of gel contains; isotretinoin USP-0.5mg

By dermatologist- for the treatment of acne vulgaris.

13/10/2004

3642

Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules

For duodenal ulcer, gastric ulcer & GERD.

15.06.07

3643

Oseltamivir (as phosphate) Capsule (75mg) & oral suspension (12mg/ml)

For influenzae.

25/10/2005

3644

Oxcarbazepine

Each film coated tablet contains; oxcarbazepine-150mg, 300mg, 600mg

Neurologists only- As monotherapy & adjunct therapy in treatment of partial seizures in adult patients with epilepsy.

30-10-2001

3645

Somatropin (r human growth hormone) (old molecule)

Each vial contains; rDNA developed human growth hormone-24IU (8mg)

By endorinologists- growth failure due to in adequate secretion of normal endogenous growth hormone.

20-12-2000

3646

Sufentanil Citrate

Anesthetic agent.

17.12.2003

3647

Temozolamide capsules 140mg/180mg (Addl. Strength)

Same as Approved.

31.03.08

3648

Amisulpiride 300mg tablets (Additional Strength)

Same as Approved.

20.03.08

3649

Celecoxib injection

2004-October

3650

Cetirizine HCl drops (10mg/ml)

Each 1ml of drop contains; cetirizine Hcl-10mg

For the treatment of seasonal/perennial allergic rhinitis & chronic idiopathic urticaria in infants & children.

10/11/2005

3651

Cladribine

Anti cancer.

09.09.2003

3652

Dexrabeprazole Sodium E. Coated tablet 5mg/10mg

For duodenal ulcer, gastric ulcer & GERD.

13.06.07

3653

Fexofenadine 120mg + Montelukast 10mg Chewable tablet

Additional dosage form

07.07.11

3654

Hepatitis-B Vaccine (recombinant)

20mcg/ml

02/03/2000

3655

Lamotrigine Orodispersible Tablet 12.5 mg (additional strength)

Same as Approved

20.03.10

3656

Montelucast 4 mg + Levocetrizine 2.5 mg tablet

Additional lower paedriatric dose.

19.03.09

3657

Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg table

Each film coated tablet contains; glibenclamide IP-5mg, metformin Hcl IP-500mg, Rosiglitazone maleate eq.to rosiglitazone-2mg

As 3rd line treatment of type-II diabetes mellitus when diet, excercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control.

08/08/2006

3658

Tobramycin + flurometholone ophthalmic suspension

Each ml contains; tobramycin sulph. USP eq.to tobramycin-3mg, flurometholone USP-1mg

Steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated & where superficial ocular bacterial infection exists.

12/09/2002

3659

Zoledronic acid powder in vial for infusion including solution

Each vial contains; zoledronic acid anhydrous-4mg

Treatment of tumour induced hypercalcemia.

05/11/2001

3660

Cefepime Injection (New indication)

For bacterial meningitis in children.

14.06.07

3661

Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : -FerrouÞ¡

As contraceptive pill for women

27.07.11

3662

Lanthanum Carbonate Chewable tablet (250mg/500mg)

For the treatment of hyperphosphatemia.

09/11/2005

3663

L- Lysine Hcl Ointment (150mg/gm)

For wounds of various etiology.

08/08/2006

3664

Nifedipine SR Tablets 10mg/20mg

For the treatment of essential hypertension.

24.03.08

3665

Rosiglitazone + metformin (SR) tab

Each uncoated tab contains; rosiglitazone maleate eq.to rosiglitazone-2mg,4mg, metformin hcl IP (in SR form)-500mg

Treatment of patients with type-II diabetes where diet, exercise and the single agent do not result in adequate glycemic control.

11/09/2002

3666

Sodium picosulfate & liquid paraffin emulsion

Each 15 ml emulsion contains; sodium picosulfate-5mg, liquid paraffin-4.8ml

For constipation in adults.

09/11/2001

3667

Sulperazone sulbactum sodium + Cefoperazone sodium

2000

3668

Surgical Sealant

To be indicated for use in sealing suture lines along arterial and venous reconstructions.

26.03.09

3669

Teriparatide

For osteoporosis.

04.09.2003

3670

Trabectedin powder for Conc. solution for infusion (Additional Indication)

In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinumsensitive ovarian cancer.

20.03.10

3671

Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrup

For symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis.

26.03.08

3672

Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule.

Each capsule contains; ambroxol Hcl (SR pellets)-75mg, desloratidine-5mg

For symptomatic relief of productive cough associated with allergic rhinitis, when both antihistamine and mucolyte agents are desired.

11/11/2005

3673

Bendrofluazide

Diuretic.

24.07.2003

3674

Cefixime (SR) 400mg + Moxifloxacin (SR) 400 mg Tablets

For the treatment of lower respiratory tract infections in adults only.

08.08.11

3675

Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules

For SAR, PAR & Chronic idiopathic urticatia.

09/08/2006

3676

Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive)

For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

26.03.09

3677

Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets

Additional higher strength

23.03.10

3678

Metformin SR (500mg) tablets

Each tablet contains; metformin hcl-500mg

For type II diabetes.

09/11/2001

3679

Phenytoin Sodium E.R (300mg)

For control of generalised tonic clonic (grand-mal) and prevention and treatment of seizures occuring during or following neurosurgery.

14.06.07

3680

Quinapril tab & bulk

Each tab contains; quinapril hcl eq.to quinapril-5mg,10mg,20mg

Mild to moderate hypertension & adjunct to cardiac glycoside in congestive heart failure.

19-09-2002

3681

Roxithromycin tablets

75mg

For paediatric use.

15/05/2000

3682

R(-) salbutamol i.e levosalbutamol rotacaps & inhalers

Each actuation delivers R(-) salbutamol sulphate eq.to R(-) salbutamol-50mcg,100mcg.

By RMP only- for the treatment of bronchospasm in patients with reversible obstructive airway diseases.

2004-October

3683

Acebrophylline Syrup 10mg/ml (Additional Indication)

For the treatment of children (age 6 to 12 years) with chronic obstructive pulmonary disease(COPD) and bronchial asthma.

30.03.09

3684

Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets

For the treatment of Diabetic neuropathy.

10.08.11

3685

Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet

Each uncoated bilayered tablet contains; alprazolam IP-0.25mg (SR), sertraline hydrochloride eq.to sertraline-25mg,50mg

For the treatment of Panic disorder with or without agoraphobia.

07/08/2005

3686

Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup

For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis.

26.03.08

3687

Beractant intratracheal suspension (sterile)

Each ml contains; phospholipids-25mg, sodium chloride-9mg

Indicated for the prevention and treatment of respiratory distress syndrome in prematute infants.

02/10/2000

3688

Diclofenac sodium SR Tablet 150 mg

For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondilytis,gout,painful post perative pain following dental surgery etc.

26.03.10

3689

Organ preservative solution

Stated as "not defined as drugs" in UK/USA; it is under "medical devices".

2004-October

3690

Sodium Hyaluronate 0.1% eye drops (addl.Strength)

Ophthalmic use.

10/11/2005

3691

Synthetic ACTH bulk

15-11-2001

3692

Tranexamic acid Mouth Wash (50mg/ml)

For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery.

15.06.07

3693

Betamethasone + gentamycin sulph. Lotion

Each ml contains; betamethasone diprop. USP-0.064mg, gentamycin sulph.eq.to gentamycin-1mg

Treatment of infected dermatosis, infection. Eczema & contact dermatitis topical

25-09-2002

3694

Boswellia Serrata 0.05gm/gm of Cream

For the treatment of mild to moderate psoriasis.

28.03.08

3695

Deflazacort Oral Suspension (6mg/5ml) (New dosage form)

For asthma, rheumatoid arthritis when glucocorticosteriod therapy is warranted.

15.06.07

3696

Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet

Each tablet contains; dexibuprofen-200mg, 300mg, Paracetamol-500mg

For the relief of pain and inflammation associated with RA, OA & ankolysing spondylosis.

10/08/2006

3697

FDC of S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ

Each tablet contains; S(-) metoprolol succinate eq.to s(-) metoprolol tartrate (ER)-25mg, 50mg, Hydrochlorthiazide-12.5mg

For the treatment of mild to moderate hypertension in adults.

11/11/2005

3698

Formoterol fumerate + Budesonide inhaler

Each actuation delivers; formoterol fumerate-6mcg, budesonide-100mcg,200mcg

Persistent asthma where use of a combination of inhaled corticosteroids therapy & long acting beta-agonist has been found to be appropriate.

19/11/2001

3699

Gemcitabine injection

For label extension; gemcitabine alone or in combination for treatment of locally advanced or metastatic NSCLC & transition cell carcinoma of bladder.

2004-October

3700

Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength)

Same as Approved

26.03.10

3701

Mesalamine PR Tablets 1.2gm

For the induction of remission in patients with active, mild to moderate ulcerative colitis.

30.03.09

3702

Ranolazine ER Tablet 375mg/750mg (Additional Strength)

Same as approved

11.08.11

3703

Cefdinir caps & oral suspension

Additional indication of acute maxillary sinusitis & acute bacterial otitis media.

22/11/2001

3704

Etoricoxib injection 90mg/ml

For short term use in acute painful condition in adults only.

28.03.08

3705

Gadobenate dimeglumine IV Injection (Gadobenate dimuglimine 529mg equivalent to Gadobenate acid 334mg + Meglumine 195 mg) (Additional Indication)

Contrast-enhanced MR-angiography where it improves the diagnostic accuracy for detecting clinically significant stenoocclusive vascular disease in patients with suspected or known vascular disease of the abdominal or peripheral arteries.

11.08.11

3706

ISMN SR 60mg + Metoprolol Succinate ER 25/50mg

Each film coated ER tablet contains; diluted isosorbide mononitrate BP eq.to isosorbide mononitrate-60mg(SR), metoprolol succinate USP eq.to metoprolol tartrate-25mg, 50mg(ER)

For the treatment of patients suffering from angina & Hypertension.

10/08/2006

3707

Lidocaine 2.5% w/w + Prilocaine 2.5% w/w Gel

Additional higher Strength

26.03.10

3708

Mycophenolate Mofetil Tablets 750mg Additional Strength

Same as approved.

31.03.09

3709

Orlistate capsules

Each hard gelatin capsule contains; orlistate-120mg

27/10/2004

3710

Stavudine 10mg + Lamivudine 40mg + Nevirapine 70mg dispersible tablet

For HIV infection.

11/11/2005

3711

Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule

For BPH with overaction bladder in Adults only.

15.06.07

3712

Valacyclovir hcl tab & bulk

Each film coated tab contains; valacyclovir hcl eq.to valacyclovir-500mg,1000mg

Herpes zoster infection & genital herpes (initial & recurrent)

25-09-2002

3713

Voglibose (0.2mg/0.3mg) Tablet

Each uncoated tablet contains; voglibose-0.2mg, 0.3mg

For improvement of post pandrial hyperglycaemia in diabetic mellitus only when diet and/or excercise or oral hypoglycemic drugs or insulin preparations in addition to diet and /or excercise do not result adequate glycemic control.

17/11/2005

3714

Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet

Each tablet contains; i) aspirin IP-75mg + glycine-37.5mg, ii) aspirin IP-150mg + glycine IP-75mg

For primary & secondry prevention of acute coronary syndrome in patients with CAD, in prophylaxis against stroke and patients with risk of vascular thrombosis.

10/08/2006

3715

Ceftiofur sodium inj.

Each 1gm & 4gm vial contains; (on reconstitution with 20ml or 80ml sterile WFI); ceftiofur sod.eq.to ceftiofur-50mg/ml

For treatment of bovine respiratory diseases, acute bovine interdigital necrobacillosis, bacterial respiratory diseases in swine, sheeps & horses, cannine UTI & for control of mortality associated with E.coli in day old chickens & day old turkey poultry.

08/10/2002

3716

Celecoxib injection

Each ml of injection contains; celecoxib-100mg

By specialists only- for short term treatment of acute post operative pain in adults only, with a spl.condition; in patients with cardiovascular disorders celecoxib inj.should be administered with precaustion under the supervision of cardiologists/specialÞ¡

27/10/2004

3717

Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength)

Oral contraceptive in women.

28.03.08

3718

Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic Acid-1000mg, Laropiprant-20mg

26.03.10

3719

Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule

For gastric ulcer, duodenal ulcer and GERD.

18.06.2007

3720

Somatropin (recombinant) inj.

Each cartridge for injection contains; somatropin (recombinant)-36 IU (12mg powder)

Short stature due to inadequate or failed secretion of pituitary growth hormone.

23/11/2001

3721

Tacrolimus Capsules 0.5mg/1mg/5mg (Additional indication)

Lupus nephritis (in a case where the effect of steroids is insufficient or administration of steroids is difficult because of their adverse reactions).

11.08.11

3722

Theophylline 400mg SR + Montelukast 10mg Tablet

For the treatment of patients with bronchial asthma.

31.03.09

3723

Rivastigmine transdermal patch (each patch of 5cm², 10cm², 15cm² & 20cm² contain Rivastigmine base 9/18/27/36mg respectively

For the treatment of patients with mild to moderately severe dementia of the Alzheimer type and dementia associated with Parkinson's disease.

28.01.08

3724

Iodixanol Injection

Each ml contains: Iodixanol 652 mg equivalent to 320 mg I. Iodixanol 305 mg equivalent to 150 mg I. Iodixanol 550 mg equivalent to 270 mg I.

23 September 1999

3725

Fenofibrate Tablets 160 mg

Each tablet contains: Fenofibrate B.P 160mg

For Type (IIA) Type (IIB) III, IV and V Hyper Lipidaemias resistant to diet.

29.08.2002