New Drugs Approved by CDSCO
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Sr.No Drug Name Strength Indication Date of Approval
1 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 2-Sulphanilamide-5-methyl pyrimidine 0.5 g tablets Sulpha drug 1970- January
3 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
4 Acetylcystein Antimycolytic enzyme. 1966- March
5 Amylobarbitone & Trifluoperazine dihydrochloride Psychoneurotics, tranquilizer & sedative. 1967- February
6 Atenolol bulk 1986-January
7 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
8 Bromonaphthol 250 mg tabs Anthelmintic-in hookwarm infection only. 1963- February
9 Cefprozil Powder for oral suspension (125mg/5ml) Antibiotic. 06/01/2006
10 Centbucridine (0.5%) + Feracrylem (3%) For hemorrhoid & anal fissure 11-01-2005
11 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
12 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
13 Ciprofloxacin eye drops/eye oitment Ciprofloxacin-0.3% w/v Indicated in the treatment of external ocular infection of the eye. 1991- February
14 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
15 Cyproheptadine Each tablet contains; cyproheptadine Hcl-4mg 1973-January
16 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
17 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
18 Dimethindene maleate Anti-histaminic 1965- January
19 Disprospan injection Each vial contains; betamethasone dipropionate-6.43mg, betamethasone sodium phosphate-2.63mg 1984-July
20 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
21 Domperidone SR tab Each uncoated SR tab contains; domperidone BP-30mg For the treatment of chronic dyspepsia, gastro paresis, nausea & vomiting. 16-01-2003
22 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
23 Fenbendazole bulk drug 1983-january
24 Flavoxate Hydrochloride Each tablet contains; Flavoxate Hydrochloride-100mg 1981
25 Fluprednylidene-21-Acetate Each 100gm contains; Fluprednylidene-21-Acetate-0.1gm 1978
26 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
27 Lofepramine tablet Each tablet contains; lofepramine-35mg,70mg Tricyclic anti depressants- Indicated in the treatment of depressive condition only. 1990- January
28 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
29 Me-salicylate 30% + Menthol 10% + camphor 4% Cream For temporary relief from pain, swelling & inflammation due to musculoskeletal disorder. 29.11.07
30 Metaraminol bitartarate 2-10mg im/sc, 0.5-5mg iv Sympathomimetic (adrenergic) urgent vasopressor. 1964- January
31 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
32 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
33 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
34 Nitroglycerin oitnment Anti-anginal drug- Indicated in treatment of angina pectoris due to coronary artery disease. 1982-january
35 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
36 Oxiconazole nitrate Oxiconazole nitrate-1% w/v For topical treatment of superficial fungal infections of the skin 17-01-2000
37 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
38 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
39 Practolol Each tablet contains; Practolol BP-100mg 1974
40 Propranolol + Hydrallazine Each tablet contains; Propranolol-40mg, Hydrallazine-25mg 1980-February
41 Prothipendyl hydrochloride 40-120 mg/day Psycho sedative & Tranquiliser-relaxes the autonomas system. 1962- January
42 Reserpine + clopamide + dihydroergocristine Each tablet contains; Reserpine-0.1mg, clopamide-5mg, dihydroergocristine-0.5mg 1972- January
43 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
44 R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection Chemotherapy induced nausea & vomiting. 12.01.07
45 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
46 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 sarcoptř° 14.01.09
47 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
48 Sulphadiazine + Trimethoprim tablets/suspension Each tablet contains; sulphadiazine-400mg, trimethoprim-80mg, Each 5ml suspension contains; sulphadiazine-200mg, trimethoprim-40mg 1987-January
49 Tolfenamic acid cap Cap. 200mg Additional indication of migraine 07/01/2002
50 Tolnaftate 1% sol. In bottle of 10 cc Treatment of dermatomycosis. 1969- January
51 Tolnaftate + Nystatin Each gm contains; Tolnaftate-10mg, Nystatin-100,000 Units 1977-February
52 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
53 Tramadol SR Moderate to severe pain. 27/01/1998
54 Trimethoprim + Sulphamethoxozole Each 3mL ampoule contains; Trimethoprim-160mg, Sulphamethoxozole-800mg 1979-January
55 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
56 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
57 Trofodermin cream Each 100gm contains; clostebol-500mg, neomycin sulphate-500mg 1985-June
58 Zoalene + Ethoxyquin Zoalene-25%, Ethoxyquin-0.125% 1975- January
59 Acetyl salicylic acid + Aluminium Hydrochloride + Magnesium Hydrocloride Each tablet contains; Acetyl salicylic acid-350mg, Aluminium Hydrochloride-90mg, Magnesium Hydrocloride-90mg 1981-November
60 Alphachymotrypsin Each tablet contains; Alphachymotrypsin- 25chg units 1975-July
61 Epi-Growth Factor 1gm + Silversulphadiazine Cream For Burns. 19.10.2004
62 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
63 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
64 Aripiprazole tablets Each uncoated tablet contains; aripiprazole-5mg Psychiatrist only- for the treatment of schizophrenia. 23/02/2004
65 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
66 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
67 Bismuth aluminate New bismuth salt (antacid). 1962- April
68 Bisoprolol fumerate 2:1 + hydrochlorthiazide Bisoprolol fumerate (2:1)-2.5mg,5mg, hydrochlorthiazide-6.25mg Mild to moderate hypertension. 13-05-1999
69 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
70 Canagliflozin, 100 & 300 mg Tablet Each film coated tablet contains; canagliflozin-100mg, 300mg ‚??Indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type-2 Diabetic Mellitus‚?Ě. 17.11.14
71 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
72 Chloramphenicol Each capsule contains; chloramphenicol-500 mg 1972- October
73 Chlordantoin + Benzylkonium chloride Each 100gm contains; Chlordantoin-1%, Benzylkonium chloride-0.05% Anti-fungal agent 1970- August
74 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 adjuvanř° 01.07.2012
75 Clozapine tablets Each uncoated tablet contains; clozapine-25mg, 100mg. Indicated in the management of schzophrenic patients. 07/03/1995
76 Cyclandelate Each capsule contains; Cyclandelate-200mg 1977-July
77 Desloratadine tabs. Each tablets 5mg desloratadine For additional indication; chronic idiopathic urticaria 14-01-2002
78 Dexchlorpheniramine maleate Each tablet contains; Dexchlorpheniramine maleate-2mg 1976-July
79 Diltiazem inj. Each ml contains; diltiazem hcl-5mg 16/05/1994
80 d-norgestrel + ethinyloestradiol Each tablet contains; d-norgestrel 0.25mg, ethinyloestradiol-0.05mg 1971- April
81 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
82 Fluocortolone caproate + Fluocortolon Trimethyl acetate Each 100gm contain s;Fluocortolone caproate-0.25gm, Fluocortolon Trimethyl acetate-0.25gm 1978-June
83 Glipizide + Metformin tablets Each tab contains; glipizide-2.5mg,5mg, metformin-250mg,500mg For non insulin dependent diabetes mellitus. 20/03/1998
84 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
85 Gugulipid Lipid lowering agent 1986-June
86 Gugulipid tablets Each tablet contains; gugulipid eq.to guggulsterone-25mg 1987-March
87 Lynestrenol + Ethinyloestradiol 22 active tablets, each contains; Lynestrenol-1mg, Ethinyloestradiol-50mg, 6 Placebo tablets contain Ferrus Fumerate-60mg 1980-June
88 Mebhydroline Napadisylate 50mg tabs Antihistaminic 1964- February
89 Mepartricin tablet Each enteric coated tablet contains; mepatricin-50000units Functional disorders in benign prostatic hypertrophy. 28/05/1993
90 Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet For acute painful musculoskeletal condition in adult. 22/02/2005
91 Miconazole Nitrate Miconazole Nitrate-2% 1979-March
92 Mitoxantrone bulk drug 1989-March
93 Nalbuphine injection 10mg/20mg per ml. Eacl ml contains; nalbuphine HCl-10mg, 20mg For the relief of moderate to severe pain. 08.02.07
94 Norethisterone acetate and ethinyl oestradiol 1 mg (20 tabs) Oral contraceptive 1967- April
95 Norgestrel + Ethinyloestradiol Oral contraceptive 1968- August
96 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
97 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
98 Orciprenaline sulphate Sympathomimetic 1965- April
99 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)ř° 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 oř° 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 ‚?• 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-20mg√?2, clarithromycin tab-500mg√?2, amoxycillin cap-500mg√?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 MTXř° 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 satisfactoř° 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 36ř° 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 ‚??treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation‚?Ě 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, iř° 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 ‚?¶.. ...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 earř° 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 ř° 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 cř° 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-15¬Ī5%, nylon fiber-53¬Ī3%, polyester fiber-16¬Ī3%, polyurethane binder-4¬Ī2%, elastomer (Lycra) fiber-12¬Ī5%. 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 anotheř° 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 arř° 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 ř° 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 ‚?§ 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 wř° 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 surgicař° 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 Philař° 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 therapyř° 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.ř° 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.ř° 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 2ŠĶ? to 8ŠĶ?. 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 Atorvastař° 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 Ramiprř° 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 ‚??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 ‚?• 4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ‚?• 50% - a gesř° 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 Capsules  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 Eř° 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 ř° 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: ¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†¬†ř° 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. coř° 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 sř° 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 (stař° 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 Troxipide  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.  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 approvalsř° 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 Juveř° 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 100mgř° 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 weař° 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-ř° 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 CNSř° 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, cirhosř° 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 PPARő≥ 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 PPARő≥ agonist. ř° 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 ‚?? 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 Tablet  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 ař° 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 ő≤-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.ř° 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 peroxideř° 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 Disoř° For the treatment of HIV infections in adults. 19.07.10
985 Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm¬≤, 12.5cm¬≤, and 25cm¬≤contains: Buprenorphine‚?¶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 indicateř° 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 indicatedř° 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 arrhythmř° 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, imř° 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 uncomplicař° 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 treatment  of acute and chronic pain, 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 Zolmitriptan 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 Pour‚??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 coř° 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 admř° 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) 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 wř° 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 cř° 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 (‚?• 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 3¬į and 4¬į 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 (‚?• 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 polymaltř° 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 stř° 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 withř° 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 inhř° 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 transpř° 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 &ř° 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 Pediatř° 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 ‚?•27 kg/m2 in presence of other risk factors (viz.hypertension, diabetes, dř° 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, gř° 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); age‚?•75 years; hypertension; diabetes mellitř° 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 Injection  (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 ř° 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 (‚?•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 prostatiř° 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 tř° 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 magnaeseř° 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 na√Įve 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 Hcl  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 tř° 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: ‚?Ę 1000ml of electrolyte solution in Compartment A contains: Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm Lactic ř° 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 Tablets  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 adjuvantř° 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 injectioř° 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 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 prednisolonř° 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 5% 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-5mgř° 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.¬†For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk ř° 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 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. 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) ‚?? 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 ineffectiveř° 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)  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 Tablets‚?¶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. fř° 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 injection (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 degreř° 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.¬†(2) Bovine ketosis. (3) Musculoskeletal conditions. (4) Shock. (5) Parturient paresis (supportivř° 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 indiviř° 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 ‚?¶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 Hydrolysate¬† injection (Lyophilised) ‚?¶..1050mg / 2100mg (approx)¬†¬† equivalent to nitrogen‚?¶.30mg / 60mg respectively.¬† 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 ő≤-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 contař° 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 rř° 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 paediatriř° 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 ř° 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 agentsř° 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 basř° 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 coř° 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 ‚?¶30mg/60mg Each film coated tablet contains; dapoxetine hydrochloride eq.to dapoxetine-30mg, 60mg For the treatment of premature ejaculation¬†(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 1% 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.  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 ofř° 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,ř° 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/2ml¬† 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 predominř° 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 + LPř° 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.¬† 2) Each 3.5gm of vaginal pessary contains; Aqueous extract of Triticum Vulgare (dry residue 200mg/100ml)-0.60gm, 2-phenoxyř° 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/ml  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 ř° 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 ř° 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.  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. 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 hyperliř° 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 (heterozygoř° 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 panř° 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 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 giř° 28.05.10
2460 Thiamine propyl disulphide 1969- July
2461 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
2462 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
2463 Trofosfamide indicated in the treatment of lymphogranulomatosis, lymphosarcoma, reticulosarcoma,ovarian carcinoma, carcinoma of breast. 1975- November
2464 Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet For osteoporosis. 01/02/2006
2465 Allopurinol Each tablet contains; 100mg of allopurinol In the treatment of gout and secondry hyperuricaemia. 1969- March
2466 Aluminium salicylate Anti-diarrhoeial, antiseptic. 1965- February
2467 Amineptine tablets Each tablet contains; amineptine hcl-100mg Anti depressant- Indicated in the treatment of all types of depression. 1988-January
2468 Arteether injection i.m Each ampoule contains; arteether-150mg Same as artesunate (Antimalarial) 14/01/1997
2469 Betahistine hcl Each tablet contains; 16mg 20-01-2000
2470 Betamethyl Digoxin Each tablet contains; Betamethyl Digoxin-0.1mg & 0.5mg, Liquid; Betamethyl Digoxin-0.6mg, Injection; Betamethyl Digoxin-0.1mg 1978-March
2471 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
2472 Bisoprolol 2.5mg tablets NOC issued for the additional indication of congestive heart failure (CHF). 19-01-2001
2473 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 ř° 17.01.17
2474 Cefaclor modified release tablet Each MR tablet contains; cefaclor-375mg,750mg. 27/01/1995
2475 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
2476 Colistin sulphomethate + Dibucaine Each vial contains; Sterile powder of colistin sulphomethate sodium eq to 10,000,00 Units, Dibucaine Hcl-2mg 1980-February
2477 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 inř° 25.02.15
2478 Estradiol valerate tab 1mg/2mg 1mg, 2mg 02/03/1998
2479 Ethacrynic acid USP Each tablet contains; ethacrynic acid USP-25mg & 50mg non-Thiazide saluretic diuretic. 1973-February
2480 Ethambutal dihydrochloride 100, 200 & 400 mg tablets Mycobacterium tuberculosis. 1968- March
2481 Ferrous sulphate 150 mg sustained release 1971- January
2482 Fibrinolysin and Desoxy ribonuclease combined (Bovine) Enzymes useful in removal of exudates and clots from wound and promote healing. 1962- February
2483 Fluconazole tabs/caps/inj. Each cap/tab contains; fluconazole-50mg,100mg,200mg,150mg, Fluconazole i.v injection contains; fluconazole-2mg/ml 26/04/1993
2484 Fusafungine Each Aerosol cartridge contains; Fusafungine Hcl-25mg 1977-March
2485 Fusidic acid eye drops Each gm contains; fusidic acid BP-10mg 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. 03/03/1992
2486 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
2487 ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength) Same as Approved 02.01.08
2488 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
2489 Labetolol tablets Each tablet contains; labetolol hydrochloride-50mg,100mg,200mg 1987-January
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-Hodgkin‚??sř° 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 400mg  Each film coated tablet contains; raltegravir potassium 434.4mg eq.to raltegravir-400mg In combination with other anti retroviral agents for  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 ‚??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 therapy‚?Ě. 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 ‚??For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had¬†an inadequate response or intolerance to Methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic diseaseř° 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 17ő≤-estradiol intranasal spray Each spray (0.07ml) delivers; 17-ő≤-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 Allergen Extracts Contact allergic conditions- to be supplied to clinics & physician having facilities to conduct such test and prescription from the specialist. 1979-January
2522 Ambroxol + Guaiphenesin + Menthol + Pseudoephedrine Ambroxol-30mg, guaiphenesin-100mg, menthol-01mg, pseudoephedrine-60mg Cough congestion 29-10-1999
2523 Aminophylline CR 225/350mg Asthma, COPD, Bronchitis. 21.03.07
2524 Amlodipine + benazepril hcl tabs/caps Each cap contains amlodipine (as besylate)-2.5mg,5mg, benazepril-10mg,20mg Hypertension 22-03-2002
2525 Amoscanate bulk/tablets Each tablet contains; amoscanate-250mg Indicated in treatment of adult hookworm infestation only. 1985-November
2526 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
2527 Cefotaxime sodium Antibiotic- Indicated in the treatment of patients with serious infections. 1987-April
2528 Ceftizoxime sodium sterile Each vial contains; 500mg,1000mg. 3rd generation cephalosporin. 1990-May
2529 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
2530 Dicloxacillin Antibiotic- infection of respiratory tract, skin and mucosa infection, bone infection. 1978-July
2531 Diphenoxylate Hcl. 1969- July
2532 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
2533 Fluticasone furoate nasal spray Each spray delivers; fluticasone furoate-27.5mcg For the treatment of symptoms of allergic rhinitis. 20.03.09
2534 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
2535 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
2536 Halquinol Antiamoebic, antidysentric. 1965- September
2537 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
2538 Nelfinavir 625mg tablet (addl.strength) For HIV patients. 20/05/2005
2539 Nicorandil E.R Tablet (10mg/20mg) Angina pectoris. 24/04/2006
2540 Pipazethate Dragee-20mg, drops-40mg/ml Antitussive. 1961- September
2541 Polio virus vaccine live (oral) 0.1 ml Prophylactic, immunological 1962- November
2542 Progesterone micronized soft gelatin caps. 21/06/1995
2543 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
2544 Reserpine + clopamide + dihydroergocristine Diuretic 1971- October
2545 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
2546 S (+) Etodolac 300mg + Thiocolchicoside 8mg Tablet For the treatment of patients with acute painful musculoskeletal conditions. 05.01.11
2547 Sodium Cromoglucolate Anti-asthmatic drug 1972-November
2548 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 infectionsř° 11/11/1996
2549 Tacrolimus Capsules 0.25mg For the prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplant. 03.12.12
2550 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
2551 Trimethoprim + Sulphadoxine Bacterial infections in cattle. 1973-September
2552 Abacavir sulphate tablets & bulk Each tablet contains; abacavir sulphate eq.to abacavir-300mg HIV infection in combination with other antiretroviral agent. 22-03-2002
2553 Amantadine Hydrochloride Parkinsonism 1972-December
2554 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
2555 Aprotinin Acute Pancreatites. 1973-November
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 vehiř° 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 ‚?§ 72 hours of age with RDS (confirmed by clinical and radiologic findings) and reř° 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 ř° 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 Terlipressin acetate injection i.v Each vial contains; terlipressin acetate-1mg In the treatment of bleeding oesophagal varices. 22/07/1995
2616 Amoxycillin + Clavulanic acid Amoxycillin-250mg, clavulanic acid-125mg 13-12-1999
2617 Bleomycin Anticancer 1973-December
2618 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
2619 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
2620 Edrophonium chloride 10 mg Cholinergic & curare antagonist. 1961- October
2621 Flumequine Respiratory tract infections. 1987-September
2622 Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250 /500mcg) dry powder inhaler For Asthma & COPD. 10/05/2006
2623 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
2624 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
2625 Ifosfamide Anticancer- indicated in the treatment of ovarian, breast, testicular carcinoma, hyper nephrone, pancreatic carcinoma and malignant lymphoma. 1978-September
2626 ISMN 60mg Sr + Atenolol 50mg/100mg For angina pectoris 23.03.07
2627 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
2628 Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet For the treatment of patients with diabetic polyneuropathy. 05.01.11
2629 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
2630 MI cu 250 Intra-uterine device 1979-May
2631 Ornidazole vaginal tabs. Each uncoated vaginal tab.contains; ornidazole-500mg Trichomonal vaginitis & non-specific bacterial vaginitis. 04/07/2001
2632 Orthoclone sterile (OKT-3) Indicated for acute allograft rejection and in renal transplant patients (Immunosppressant) 1990-October
2633 Paspat injection (finished form for import) Bronchial asthma, spastic bronchitis, allergic rhinitis, summer conjuctivitis, allergic dermatosis. 27/05/1993
2634 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
2635 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
2636 Propafenone hydrochloride Anti arrhythmic agent- Indicated in the treatment of ventricular extra systoles supra ventricular tachycardia etc. 1986-November
2637 rDNA hepatitis B vaccine (10mcg) 10mcg At a dose of 10mcg up to an age of 19 years approved. 15-09-2000
2638 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
2639 Septopal beads and chains Indicated for the treatment of bone and soft tissue infections. 1985-January
2640 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
2641 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 leř° 16.01.09
2642 Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) For Plaque psoriasis. 24/05/2005
2643 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
2644 Testolactone 1971- November
2645 Vitamin D3 (Cholecalciferol) Orally disintegrating strips 2000 IU (additional Dosage form) For the treatment of Vitamin D3 deficiency. 01.10.15
2646 Aminoglutethimide tablets Anti cancer- In the treatment of metastatic breast cancer. 1985-August
2647 Amoxycillin trihydrate bolus Each bolus contains; amoxycillin trihydrate-750mg 16/10/1996
2648 Carbenoxolone Sodium Gastric ulcer 1973-December
2649 Centchroman tab 30mg Each tablet contains; centchroman-30mg Used as a oral contraceptive. 1990- November
2650 Clonazepam tabs. Each tab.contains; clonazepam-0.25mg Additional indication; petitmal, its variant, akinetic & myoclonic seizures. 05/07/2001
2651 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 controllř° 04.11.09
2652 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
2653 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
2654 Flurbiprofen 50 & 100mg Non steroid anti inflammatory- Indicated in the treatment of rheumaoid arthritis, Oesteoarthritis and allied disorders. 1979-July
2655 Gabapentin caps Each capsule contains; gabapentin-300mg,400mg Epilepsy. 03/08/1995
2656 Gatifloxacin tabs/inj. Additional indication- for skin & skin structure infection. 2004-July
2657 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 ř° 05.12.12
2658 Glucagon Hypoglycemic agent- indicated in the treatment of severe hypoglycemic reaction in diabetic patients. 1978-October
2659 Labetolol hydrochloride Anti hypertensive agent- Indicated in the treatment of all forms of hypertension (except hypertension of pregnancy) 1986-December
2660 Levonorgestrel 0.03mg tablet For control of fertility 23.03.07
2661 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
2662 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
2663 Methandienone Each ml contains; methandienone-22.5mg to 27.5mg 1969- September
2664 Midazolam (as maleate) 7.5mg/15mg tablet For insomnia. 10/05/2006
2665 Moxidectin 1% w/v injection Moxidectin-1% w/v In the treatment and control of internal and external parasites in cattle. 16/01/1997
2666 Nadifloxacin 1% cream & bulk Each gm contains; nadifloxacin-10mg Acne vulgaris (patients with multiple inflammatory lesion) 28-03-2002
2667 Neutral insulin & Insulin zinc suspension (Human insulin) injection In the treatment of insulin requiring diabetics by injection or infusion. 1987-September
2668 Nitroglycerin patches (finished formulation) Each patch contains; nitroglycerin-25mg,50mg For the treatment of angina pectoris due to coronary artery disease. 03/06/1993
2669 Oxyphenbutazone 0.1gm Anti-inflammatory, antipyretic. 1961- November
2670 Rofecoxib suspension (oral) Each 5ml suspension contains; rofecoxib-12.5mg,25mg. Not to be used in children 25-09-2000
2671 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
2672 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
2673 Spiramycin inj. 1971- November
2674 Spironolactone IP 25mg + Furosemide IP 40mg Tablet Additional strength 05.01.11
2675 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
2676 2-thymyloxy methyl Glyoxalidine Hcl 0.05% Vasoconstrictor. 1961- November
2677 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
2678 Betamethasone-17-Benzoate Topical anti-inflammatory steroid. 1973-December
2679 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
2680 Bortezomib 2mg/vial (additional pack size) As approved 28.03.07
2681 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
2682 Clopamide 20mg Diuretic- indicated in the treatment of oedema of cardiac hepatic or renal origin and hypertension only. 1979-July
2683 Colistin sulphate + pectin + kaolin 30ml suspension contains; Colistin sulphate-0.154g, pectin-0.196g, kaolin-2.625g 1969- July
2684 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
2685 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 1ŠĶ? and 2ŠĶ? internal haemorrhoids. 17.11.09
2686 Febuxostat 40mg (Additional Strength) Same As approved 16.01.10
2687 Fenofibrate capsules Each capsule contains; fenofibrate-200mg (micronized) For type IIa, IIb, III, IV & V hyper lipidaemias resistant to diet 22-12-1999
2688 Gatifloxacin (200mg) + Ornidazole (500mg) tablet For diarrhoea of mixed infection in adults. 06/06/2005
2689 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
2690 Infliximab injection For additional indication- in maintenance therapy of Crohn's disease & fistulising Crohn's disease. 15/07/2004
2691 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
2692 Measles vaccine Each 0.5ml dose contains measles virus (CAM-70 strain) not less than 1000 CCID50 Active immunization against measles. 02/04/2002
2693 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
2694 Olmesartan (as Medoxomil) 10mg (addl. Strength) Anti-hypertensive. 18/05/2006
2695 Rabies veterinary vaccine inactivated 1987-November
2696 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
2697 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
2698 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
2699 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
2700 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
2701 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
2702 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
2703 Zolpidem Tartarate Orally disintegrating Tablet 5mg/10mg (Additional dosage form) For insomnia. 12.10.15
2704 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
2705 Amoxycillin Antibiotic- indicated in the treatment of urinary tract infections, respiratory, genito-urinary, ENT and soft tissue infections. 1978-December
2706 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
2707 Bleomycin oil suspension for injection Anti cancer- Indicated in the treatment of neck & head cancer malignant. 1985-September
2708 Carbazochrome salicylate Each ml contains; Carbazochrome salicylate eq.to 5mg of adrenochrone monosemicarbazone 1969- July
2709 Chelate amino acid based minerals (finished formulation) Trace mineral deficiencies. 20/07/1993
2710 Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) For HIV infection in adults. 07/06/2005
2711 Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg For HIV infection 02.04.07
2712 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
2713 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
2714 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
2715 Etodolac i.m injection 400mg/2ml (Additional dosage form) For the treatment of post operative orthopaedic pain. 14.12.15
2716 Fluconazole tab Fluconazole-400mg Additional strength 2003
2717 Gemcitabine injection Gemcitabine hcl eq.to gemcitabine-200mg,1000mg In the management of non small cell lung cancer. 24/01/1996
2718 Influenza vaccine inactivated for equine. For treatment of Influenza in equine. 1987-November
2719 Iohexol Sterile Sol. X-ray contrast medium- Indicated in neuroradiology, angiography, urography, arthrography etc. 1986-june
2720 Lamivudine oral solution 25mg/5ml For the treatment of chronic hepatitis B virus infection. 30-12-1999
2721 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
2722 Methylcobalamin orally disintegrating strips 1500mcg (add. Dosage form/ indication) For the treatment of peripheral neuropathy and diabetec neuropathy. 17.12.14
2723 Natamycin Natamycin-2% Trichonomial agent- indicated in the treatment of vaginal irritation & discharge due to monilial, trichomonial infections. 1979-September
2724 Paracetamol Chewable Tablet 500 mg. (Additional Dosage Form) Same as approved 05.01.11
2725 Phenelzine dihydrogen sulpha Anti-depressant. 1961- November
2726 Pregabalin Capsule 25/50/100/200mg (addl. Strength) Same as approved. 19/05/2006
2727 Stronger neo minophagen-c injection Same as above For additional indication of cirrhosis with activity. 05/05/1999
2728 Thiophanate Anthelmentic 1973-December
2729 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
2730 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
2731 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
2732 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
2733 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
2734 Doramectin 1% injectable solution 1% injectable solution For control of GI round worm, eye worm, screw worms in sheep & swine. 03/10/2000
2735 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
2736 Glycopyrrolate ampole 1mL contain 0.2mg of Glycopyrrolate 1979-September
2737 Hamycin Anti-fungal, anti-biotic. 1961- November
2738 Iron sorbitol citric acid complex Each ml contains eq.of 50mg of Iron as iron sorbitol citric acid complex. 1969- July
2739 Measles (Edmoustan zagreta strain) mumps and rubella vaccine 1987-December
2740 Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule For diabetic neuropathy 02.04.07
2741 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 butyricumř° For Vitamins and Minerals deficiency states in adult patients. 11.01.11
2742 Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form) For allergic rhinitis & chronic urticaria. 28.01.08
2743 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
2744 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
2745 Oxcarbazepine S.R 450mg/900mg Tablet (addl. Strength). Anti-epileptic. 18/05/2006
2746 Oxyfedrine Coronary vasodilator 1973-April
2747 Paclitaxel suspension for injection Conc. For nanodispersion 100/300mg (add. Indication) Management of endometriosis associated pain. 18.12.14
2748 Paracetamol suppositories Each suppository contains; paracetamol-80mg, 170mg For symptomatic relief of pain & fever. 10/07/2001
2749 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
2750 Prednisolone + Ofloxacin 2003
2751 Purified chick embryo cell (PCEC) tissue culture rabies vaccine Vaccine- Indicated for treatment after exposure to rabies and for pre-exposure prophylaxis. 1985-November
2752 Sodium hyaluronate 2% Injection Each ml of pre-filled syringe contains; sodium hyaluronate-20mg To be used for facial tissue augmentation. 14.01.09
2753 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
2754 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
2755 Urovison Mixture of Sodium salt of and methyl glucanine salt of diatrizoate(40:18) Contrast media. 1978-December
2756 Zalcitabine film coated tablets (finished formulation) Each film coated tablet contains; zalcitabine-0.375mg,0.750mg For the treatment of AIDS 26/07/1993
2757 Abciximab injection Each 5ml vial contains; abciximab-10mg 02/05/1997
2758 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
2759 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
2760 Calcium citrate malate (bulk) 24.02.09
2761 Cefpodoxime proxetil tabs/dry syrup i)-Each tab contains; cefpodoxime proxetil-100mg, ii)-cefpodoxime proxetil dry syrup-40mg/5ml 12/03/1996
2762 Ciclesonide rotacaps (200/400mcg) For Asthma. 19/05/2006
2763 Dequalinium acetate Bacteriostatic and fungistatic. 1961- November
2764 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
2765 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
2766 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
2767 Furaltadone 1973-June
2768 Galanthamine Hydrobromide Treatment of neuritis & poliomyelitis, infantile cerebral palsies. 1978-December
2769 Guanethidine sulphate Each ml contains; guanethidine sulphate-10mg 1969- October
2770 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 moř° For patients requiring parental nutrition in energy depletion as well as essential fatty acid deficiency states. 11/07/2001
2771 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
2772 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 ř° 22.12.14
2773 Metronidazole + benzocaine topical gel Each gm of gel contains; metronidazole (as benzoate)-10mg, benzocaine-200mg RMP- for treatment of gingivitis 2003-September
2774 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
2775 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-baseř° 16.01.10
2776 Propofol 10mg + Lignocaem 1mg per ml injection For induction of anesthesia 04.04.07
2777 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
2778 Cefoperazone sodium inj. Im/iv Each vial contains; cefoperazone sodium-1g,2g 23/08/1993
2779 Emtricitabine (200mg) capsule Each capsule contains; emtricitabine-200mg For HIV infection in adults. 09/06/2005
2780 Ethosuximide TAB-250MG, Syrup-5ml=0.25g Anticonvulsant for petitmal epilepsy 1961- December
2781 Ezetimibe 10mg + Fenofibrate 160mg tablet For combined hypertipidemia 04.04.07
2782 Feracrylum oral capsule Each capsule contains; feracrylum-100mg Gastroenterologists-for the treatment of non ulcer dyspepsia associated with H.Pylori 2003-September
2783 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
2784 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
2785 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
2786 Leuprolide acetate depot inj. For additional indicatio; of endometriosis & uterine leiomyomata in women. 17-07-2001
2787 Linezolid IV inj. Each ml contains; linezolid-2mg, dextrose-5% Complicated/uncomplicated skin & skin structure infections/community acquired pneumonia. 01/04/2002
2788 Lorazepam Psychiatric drug. 1973-September
2789 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
2790 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
2791 Mycophenolate mofetil caps/tab (finished formulation) Each cap/tab contains; mycophenolate mofetil-250mg,500mg For organ rejection in renal transplant etc. 07/02/1999
2792 Oseltamivir 30mg & 45mg Capsules (Additional Strength) Same as Approved. 28.01.08
2793 Pericyazine Pericyazine-2.5mg & 10mg Specialists/hospital 1969- October
2794 Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution For hygenic and surgical hand disinfection. 18.01.10
2795 Rebamipide tablets Each film coated tab contains; rebamipide-100mg By gastroenterologists-for the treatment of gastric intestinal ulcers in adults only. 29/07/2004
2796 Venlafaxine hcl Each capsule contains; venlafexine hcl eq.to venlafaxine-37.5mg,75mg,150mg as extended release pellets. Major depression 06/10/2000
2797 5-Fluorouracil Each 5ml vial contains; 5-Fluorouracil-250mg Caution 1979-January
2798 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
2799 Atenolol 50mg + HCTZ 25mg (addl. Strength) For hypertension. 03/02/2006
2800 Azelastine nasal spray Additional indication- for children in the age group of 6-12 years. 08/01/2002
2801 Bethanidine sulphate 10 & 50 mg tablets Hypertensive drug. 1968- June
2802 Bezafibrate retard tablet Each film coated retard tab contains; bezafibrate-400mg 02/04/1993
2803 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
2804 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
2805 Ursodeoxycholic acid tablets 600mg For the treatment of patients with chronic cholestatic liver disease. 30.01.08
2806 Calcium gluconate + isothipendyl + acetylsalicylic acid + Caffeine Each dragee contains; calcium gluconate-50mg, isothipendyl hcl-4mg, acetylsalicylic acid-200mg, Caffeine-30mg 1972- June
2807 Ceftaroline Fosamil Injection 600 mg/Vial Ceftaroline fosamil powder for concentrate for solution for infusion-600mg/vial "For the treatment of adult (‚?• 18 years of age) patients with community-acquired pneumonia". 09.05.16
2808 Centbutindole tablets Each tablet contains; centbutindole-1.5mg 1987-February
2809 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
2810 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
2811 Cyclopenthiazide 1-2 Tablets daily Non-mercurial oral diuretic & hypotensive. 1962- February
2812 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 witř° 18.01.17
2813 Desloratadine + Pseudoephedrine (SR) tablets Each tablet contains; desloratadine-2.5mg,5mg, pseudoephedrine SR-120mg,180mg 2004
2814 Dichlorphenamide 50mg tabs Carbonic anhydrase inhibitor. 1964- January
2815 Diclofenac potassium sugar coated tabs Each sugar coated tablet contains; diclofenac potassium-50mg 18/03/1994
2816 Diethylamine Salicylate Diethylamine Salicylate-10% w/w For external use only 1978-March
2817 Difluprednate Opthalmic Emulsion 0.05% w/v Each ml contains; difluprednate-0.5mg For the treatment of inflammation and pain  associated with ocular surgery.  01.04.10
2818 Disophenol Each c.c contains; disophenol-45mg Treatment of hook worm in dogs and cats. 1970- April
2819 dl-naorgestrel + Ethinyl oestradiol Each tablet contains; dl-naorgestrel-0.5mg, Ethinyl oestradiol-0.03mg Oral contraceptive 1975- April
2820 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
2821 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
2822 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
2823 Halobetasol 0.05% + Clotrimazole 1.0% cream For the treatment of steroid responsive fungal infections including eczema and psoriasis. 04.01.08
2824 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
2825 Iron polymaltose 2ml=100mg Fe Antianaemia-iron therapy. 1963- April
2826 isoniazid + Ethambutol + Vitamin B6 Each tablet contains; isoniazid-300mg, ethambutol-800mg, vitamin B6-10mg Anti-TB fide 21-01-2000
2827 KFD Vaccine (Kyasanur forest disease) 1989-March
2828 Metoprolol injection Each ml contains; metoprolol tartrate-1mg 1985-August
2829 Metoprolol tartrate Antihypertensive agent- Indicated in the treatment of hypertension. 1982-March
2830 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). ř° 07.03.12
2831 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, wř° 31-01-2001
2832 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
2833 Niclosamide Anthelmintic against tape worm 1965- February
2834 O-ethoxybenzamide 200mg to 500mg Alagesic, antiphlogistic, antipyretic. 1961- February
2835 Zonisamide capsule 25/50mg (addl. Strength) Same as approved. 25/05/2006
2836 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
2837 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
2838 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
2839 Oxazepam 10 mg tabs Tranquilizer 1967-March
2840 Oxazepam 10 mg tabs Tranquiliser 1966- April
2841 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 Cushing‚??s Disease for whom Pituitary surgery is not an option or has not been curative". 18.03.15
2842 Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength) As approved 23.01.07
2843 Pyrantel tartrate In the treatment if ingestation with G.I round worm in sheep, cattle & swine (Broad spectrum anthelmintic) 1969- April
2844 Rifampicin + Isoniazid Rifampicin-300mg+INH-200mg, Rifampicin-450mg+INH-300mg, Rifampicin-600mg+INH-300mg 1983-June
2845 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 bronchodilř° 17.07.14
2846 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
2847 Saccharomyces Cerevisiae Each capsule contains; dried yeast powder-250 mg, saccharamyces cervisiae containing not less than 10 million living cells. 1971- January
2848 Salbutamol sulphate Each tablet contains; Salbutamal sulphate-4mg 1973-February
2849 Sodium Cromoglycate 1976-May
2850 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
2851 Tamoxifen citrate Each capsule contains; Tamoxifen citrate eq to 10mg of tamoxifen citrate 1981-April
2852 Tinidazole + Diloxanide furoate Each tablet contains; tinidazole-150mg, diloxanide furoate-250mg 1984-September
2853 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
2854 Tolfenamic acid caps Each capsule contains; tolfenamic acid-200mg Rheumatoid arthritis, osteo arthritis, ankylosing spondylitis and related conditions associated with pain. 04/03/1998
2855 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
2856 Aliskiren 150/160mg + Valsartan 300/320mg tablets For the treatment of hypertension. 19.01.10
2857 Calcium succinate & Iron edetate sodium 1969- October
2858 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
2859 Empty Hydroxy Propyl Methyl Celulose Capsules NA 11.01.11
2860 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
2861 Fondaparinax Sodium injection (Additional Indication) Treatment of acute coronary syndrome (ACS) with and without ST-segment elevation. 28.01.08
2862 Fusafungine Old drug with new pump system 26/03/1996
2863 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
2864 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
2865 Meloxicam inj. Each vial contains; meloxicam-5mg/ml Painful inflammatory conditions including arthritis in animals as well as pyrexia. 02/04/2002
2866 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
2867 Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg For hypertension. 24/05/2006
2868 Paracetamol Fast Release Tablet 500mg (Additional Dosage Form) Same as approved 10.02.11
2869 Pimaricin Oint-20mg/gm, Vag tab-50mg Anti fungal antibiotic for "Streptomyces natalensis". 1961- December
2870 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
2871 Rosuvastatin calcium 2003
2872 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
2873 Spenglersan colloid G Immunomodulator 02/06/1997
2874 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 ř° To be indicated for use in sealing suture lines along arterial and venous reconstructions. 31.03.09
2875 Azelastine eye drops 0.5mg/ml 05/05/2000
2876 Camostat Mesylate tablets 100mg For remission of acute symptoms of chronic pancreatitis and post-operative reflux esophagitis. 29.01.08
2877 Citicoline (750mg) tablet (additional strength), syrup 500mg/5ml (new dosage Form) (not For children) As approved 10.04.07
2878 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
2879 Famciclovir tab & bulk Each film coated tab contains; famciclovir-125mg,250mg,500mg,750mg Herpes zoster in immuno competents & immuno compromised patients. 11/04/2002
2880 Filgrastism injection (finished formulation) 1.6ml contains; filgrastin-48MU, 1ml contains; filgrastim-30MU 30/09/1993
2881 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
2882 Goserelin acetate injection Goserelin acetate eq.to 3.6mg of gesoserlin In the treatment of prostate cancer, breast cancer, endometriosis. 24/04/1996
2883 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
2884 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
2885 Kanamycin sulphate 1 g daily Antibiotic for cases resistant to other antibiotic, urinary tracks staphylococcus infections. 1961- December
2886 Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet For production cough 24/05/2006
2887 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
2888 Losartan + ramipril tabs Each tablet contains; losartan potassium-50mg, ramipril BP-2.5mg,5mg RMP- mild to moderate hypertension. 10/09/2003
2889 Mebrophen hydramine Mebrophen hydramine-25mg 1969- December
2890 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 tř° 19.01.10
2891 Prazosin mesylate Mild to moderate hypertension only 11/03/1999
2892 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
2893 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
2894 Apramycin sulphate 50gm in each 100gm. Bacterial enteritis cellibacllosis, salmonellosis in poultry. 22/07/1997
2895 Beriplast (fibrin adhesive glue) Tissue adhesion, suture support, haemostasis, wound care, sealing of body cavities and subarachnoid space only. 19/06/1996
2896 Depo-provera inj. (finished formulation) 18/11/1993
2897 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
2898 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
2899 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 infecř° 11.04.07
2900 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
2901 Feracrylum spray Each spray contains; feracrylum-1% & 3% Management of post-operative wounds, cuts, abrasion as an haemostatic agent. 24-07-2001
2902 Ferric Carboxymaltose equivalent to elemental Iron‚?¶50mg/ml Injection For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used. 11.02.11
2903 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
2904 Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe For intradermal implantation and facial soft tissue augmentation. 30.01.08
2905 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
2906 Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet For pediatric patients with HIV infection. 14/06/2005
2907 Levofloxacin tabs Levofloxacin-750mg For the treatment of complicated skin and skin structure infections only 20-06-2003
2908 Orciprenaline sulphate Orciprenaline sulphate-10mg 1969- December
2909 Rabeprazole + Mosapride SR Rabeprazole-20mg, mosapride-15mg 27/07/2004
2910 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 100mř° Total parenteral nutrition following major abdominal, major thoracic or major urological surgery. 19.01.10
2911 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
2912 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
2913 Atropine sulphate + hyoscyamine sulphate + scopolamine hcl + phenobaribotol Atropine sulphate-0.06mg,hyoscyamine sulphate-0.30mg, scopolamine hcl-0.035mg, phenobaribotol-64.8mg 1969- December
2914 Deflazacort Tablet 18mg (Additional Strength) Same as approved 30.01.10
2915 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
2916 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
2917 Ioversol injection (finished formulation) 160,240,300,320,350 Contrast medium 29/12/1993
2918 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
2919 Letrozole 2.5mg tablet (for additional indication) For induction of ovulation in anovulatory infertility (additional indication). 10.04.07
2920 Levofloxaxin inj. Levofloxacin-750mg 17-09-2003
2921 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
2922 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
2923 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
2924 Saquinavir caps In the treatment of advanced HIV infection 26-08-1997 to 26-08-1997
2925 Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml. For the treatment of patients with chronic cholestatic liver disease. 11.02.11
2926 Baclofen ER Capsule 10 mg/50 mg. (Additional Strength) Same as approved 17.02.11
2927 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 gonococcř° 2004-August
2928 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
2929 Diphenoxylate Hcl.-2.5mg + Atropine sulphate-0.025mg Each tablet contains; Diphenoxylate Hcl.-2.5mg + Atropine sulphate-0.025mg 1969- June
2930 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
2931 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
2932 Ketoprofen transdermal patches Each patch contains; ketoprofen-30mg For the relief of musculoskeletal pain & inflammation. 17-05-1999
2933 Midazolam Maleate Bulk Anesthetic. 05/07/2005
2934 Perflutren liquid microsphere injectable suspension For diagnostic use. 31/05/2006
2935 Pregabalin SR Tablet 75mg (Additional Strength) Same as approved 30.01.10
2936 Quetiapine SR Tablets 50mg (additional strength) As approved 10.04.07
2937 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 ř° 08/11/2000
2938 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
2939 Sevoflurane inhalation For induction and maintenance of general anaesthesia in all procedures and patients types. 09/07/1996
2940 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
2941 Sucrolase USP (Bulk) 12.05.09
2942 Tamsulosin hcl MR cap. each capsule contains; tamsulosin hcl (as MR pellets)-400mcg,200mcg Signs & symptoms of benign prostatic hyperplasia. 04/04/2002
2943 Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream For the topical treatment of bacterial and fungal infections. 30.01.08
2944 Calcium Polycarbophil (500mg) Tablet For additional indication; for 500mg oral tablets i) for relieving diarrhoea, ii) for improving irritable bowel syndrome 13/07/2005
2945 Cinnarizine 20mg + Dimenhydrinate 40mg tablets For the treatment of vertigo 03.02.10
2946 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
2947 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 demř° 23/08/2004
2948 Cyclosporin Eye drops (0.1%) (addl. Strength) For Ophthalmic use. 02/06/2006
2949 Dexketoprofen Trometamol ER Tablet 50mg (Additional Strength) Same as approved 21.02.11
2950 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
2951 Itraconazole inj. Each ml inj.contains; itraconazole-10mg Emperic therapy of febrile neutroprnic patients with suspected fungal infections. 29-04-2002
2952 Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) As approved 10.04.07
2953 Nimesulide suppository Each suppository contains; nimesulide-50mg,100mg, 200mg(22-3-2000) 17-05-1999
2954 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
2955 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
2956 Riluzole tablets In the treatment of patients with amyotrophic later sclerosis (motor neurone disease). 17-10-1997 to 17-10-1999
2957 Valdecoxib tabs Each tablet contains; valdecoxib-40mg Additional strength-for primary dysmenorrhoea in adult only. 2003-September
2958 Nepafenac (Bulk) 08.06.09
2959 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
2960 Atorvastatin + Ezetimibe tabs. Each tablet contains; atorvastatin-10mg,20mg, ezetimibe-10mg 13/08/2004
2961 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
2962 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
2963 FDC of Papain + Urea Ointment Each gm of ointment contains; papain USP ‚?• 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
2964 Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops For Ophthalmic use. 02/06/2006
2965 Gatifloxacin Eye drop 5 mg/ml For the treatment of bacterial conjunctivitis caused by susceptible strains. 21.02.11
2966 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
2967 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
2968 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
2969 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
2970 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
2971 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 ‚?• 30kg/m2 or ‚?• 27kg/m2 in presence of other risk factor (e.g, hypertension, diabetes, dyslipidemia)ř° 01.06.09
2972 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
2973 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
2974 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
2975 Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. For hypertension. 05/06/2006
2976 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
2977 Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) Antibiotic 20.04.07
2978 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
2979 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
2980 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
2981 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
2982 Influenza vaccine inactivated (vaxigrip) Prophylaxis against influenza. 13/08/1996
2983 Injection monocomponent insulin lispro (r DNA) Each 10ml vial contains; monocomponent insulin lispro-40 Iu/ml (rDNA origin) 01/12/1997
2984 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
2985 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
2986 Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength) Same as approved 06.02.10
2987 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
2988 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.ř° For prophylaxis & therapeutic treatment of protein depletion in children where oral/enternal nutrition is impossible/impracticable. 23-04-2002
2989 Aprepitant 40mg capsules (additional strength) Prevention of post-operative nausea & vomiting (additional indication). 24.04.07
2990 Didanosine chewable tabs Each tablet contains; didanosine-25mg, 50mg, 100mg By RMP- HIV infection when anti-retroviral therapy is wanted. 15-11-2000
2991 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
2992 Gabapentin SR 600mg tablets As adjunctive therapy in the treatment of partial seizures of epilepsy. 30.01.08
2993 Glipizide GITs tabs (gastro intestinal therapeutic system) Each tab contains; glipizide-5mg,10mg Non insulin dependent diabetes mellitus (NIDDM type-II) 21/08/1996
2994 Ketoprofen Plaster ( Size - 7cm x 10 cm) For the Relief of Musculoskeletal pain and Inflammation. 09.03.11
2995 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
2996 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
2997 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
2998 Milnacipran Hcl 12.5mg (Addl. Strength) Same as approved 06.02.10
2999 Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream For dermatoses. 06/06/2006
3000 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
3001 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
3002 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
3003 Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). For deep vein thrombosis. 08/06/2006
3004 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
3005 Chloroquine Phosphate eye drops (0.3mg/ml) For dry eye syndrome. 13/07/2005
3006 Fexofenadine hcl suspension Each 5ml contains; fexofenadine hcl-60mg For paediatric & geriatric patients. 27-08-2001
3007 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
3008 Memantine 5mg /10mg + Donepezil 5mg Tablets For moderate to severe Alzheimer's disease. 31.01.08
3009 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
3010 Olopatadime Ophthalmic solution (0.2%) (additional Strength) As approved 24.04.07
3011 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
3012 r-follicle stimulating hormone (FSH) NOC issued for additional strength of 37.5IU 19-08-1999
3013 Rofecoxib + paracetamol fdc tabs Each tab contains; rofecoxib-25mg, paracetamol-500mg By RMP- for the management of acute pain in adults only. 2003-October
3014 Ropinirole 6mg ER Tablets (Addl. Strength) Same as approved 06.02.10
3015 Sucralfate + metronidazole cream Each gm contains; sucralfate-0.07g, metronidazole-0.01g Bedsore, haemorrhoids, fistulae & fissures. 29-04-2002
3016 Topiramate tablets & sprinkle capsules For additional indication. 2004-October
3017 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
3018 2-Bromo-2-nitropropan-3-diol 1975- April
3019 Aspirin DL lysine Each vial contains; Aspirin DL Lysine-900mg 1986-April
3020 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
3021 Beclomethasone Dipropionate Beclomethasone Dipropionate-0.025%, Beclomethasone Dipropionate-0.025%+Neomycin Sulphate-0.5%, Beclomethasone Dipropionate-0.025%+ Chinoform-3% 1974-April
3022 Bitoscanate Anthelmintic 1970- April
3023 Budesonide inhaler Each metered inhaler supplies; budesonide-200mcg. Anti asthmatic- Indicated in the treatment of bronchial asthma. 1988-February
3024 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
3025 Carnecaine injection Carnecaine 2%-20mg articaine. 1987-February
3026 Carvedilol (already approved) new strength 3.125mg/6.25mg 3.125mg, 6.25mg In treatment of congestive hearth failure (CHF) 10/03/1999
3027 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
3028 Chlorphenoxamine hcl Each tablet contains; Chlorphenoxamine Hcl-12mg, caffeine IP-30mg 1972- July
3029 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
3030 Cisplatin injection/bulk Each vial contains; cisplatin-10mg,50mg Anticancer- Indicated in treatment of metastatic testicular & metastatic ovarian tumours. 1982-April
3031 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
3032 Cloxacillin sodium + Colistime sulphate intramammary infusion Each (10ml) syringe contains; cloxacillin sodium-200mg, colistine sulphate-50000 units 04/03/1998
3033 Combination of Oxethazaine, aluminium hydroxide & magnesium hydroxide Antacid, demulcent & mucosal anaesthetic. 1966- June
3034 Dehydro-emetine Anti-emetine (synthetic). 1963- April
3035 Diethylamine Salicylate + Nopoxamine Each 100gm contains; Diethylamine Salicylate-10gm, Nopoxamine-1gm 1980-March
3036 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
3037 Diphenylpyraline hydrochloride Each capsule contains; 5mg of diphenyl pyraline hcl Allergic reaction, rhinitis, urticaria, eczema (anti-histamine). 1969- April
3038 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
3039 Dronedarone (as Hydrochloride) film coated tablet .... 400 mg.¬† 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, diabř° 09.04.10
3040 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
3041 Flucortolone & flucortolone caproate Acute & chronic eczema, allergic dermatosis. 1968- July
3042 Fluvastatin Tablet (As calcium) 10mg/20mg/40mg (additional strength) As approved 29.01.07
3043 Fosinopril sod.tab & bulk Each tab contains; fosinopril sodium-10mg,20mg,40mg Mild to moderate hypertension. 10/01/2002
3044 Hydroxyethyl theophylline + Theophylline Monohydrate Each sustained release tablet contains; Hydroxyethyl theophylline-231 mg, Theophylline Monohydrate-69mg 1981-June
3045 Ibuprofen + Paracetamol tablets Each tablet contains; ibuprofen-400mg, paracetamol-325mg 1984-October
3046 Ilaprazole Tablets 5mg/10mg Each enteric coated tablet contains; ilaprazole-5mg, 10mg For the treatment of duodenal ulcer in adults only. 05.04.11
3047 Erdosteine Powder for oral suspension 35mg/ml For chronic obstructive bronchitis. 06/02/2006
3048 Irbesartan + hydrochlorthiazide Each uncoated tablet contains; irbesartan-150mg,300mg, Hydrochlorthiazide-12.5mg By RMP- for mild to moderate hypertension. 31-01-2001
3049 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
3050 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
3051 Lynestrenol 2.5mg & Mestranol 0.075mg 100 mg tabs (22 tablets) Oral contraceptive 1967- April
3052 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
3053 Methotrimeprazine (acid maleate) tab-5mg, 25mg,100mg, amp- 25mg/cc 1964- January
3054 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 ř° 13/04/1992
3055 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
3056 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
3057 Norethisterone B.P. Each tablet contains; Norethisterone B.P-0.35mg 1977-May
3058 N-Phenylethyl anthranilic acid N-Phenylethyl anthranilic acid-300mg 1978-April
3059 Olanzapine Each tablet contains; 5mg,7.5mg,10mg,2.5mg For treatment of schizophrenia in adults 27-01-2000
3060 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
3061 Polythiazide 2-4 mg daily Non-mercurial oral diuretic & hypotensive. 1962- February
3062 P-Piperidineethoxy-O-Carbomethoxy Benzophenone Hydrochloride 5mg to 10mg Antispasmodic and analgesic. 1961- February
3063 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
3064 Prednisolone stearoylglycolate Each tablet contains; prednisolone stearoylglucolate-6.65mg, ointment- 1.9g, cream & ointment- 1.9 g 1971- February
3065 Ranitidine syrup Each 10ml contains; ranitidine hcl eq.to ranitidine-150mg 1990- February
3066 Rifampicin syrup 1983-June
3067 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
3068 Sulphamethoxy diazine Antibacterial 1965- February
3069 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 suř° 06/05/1994
3070 Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet For BPH. 06/02/2006
3071 Tenoxicam tablet Each tablet contains; tenoxicam-20mg NSAID- rheumatoid arthritis, osteoarthritis, arthrosis, ankylosing spondylitis, gout, non-articular rheumatic conditions. 29/04/1993
3072 Theophylline Anhydrous + Ephedrine Hcl + Diazepam + prednisalone Each tablet contains; Theophylline Anhydrous-100mg, Ephedrine Hcl-10mg, Diazepam-1mg, prednisalone-1.5mg 1973-March
3073 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
3074 Tripotassium dicitrato bismuthate 1989-March
3075 Ulinastatin for Injection 50000 IU / 100000 IU For the treatment of severe sepsis. 03.04.12
3076 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
3077 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
3078 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 laproscopř° 06.02.10
3079 Dasatinib 20mg/50mg/70mg (Additional Indication) Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase. 16.03.11
3080 Doxifluridine Capsules 100mg/200mg For carcinoma of the stomach, colon, rectum, breast, uterine, cervix and bladder. 31.01.08
3081 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
3082 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
3083 Icodextrin 7.5% peritoneal dialysis solution For peritoneal dialysis. 08/06/2006
3084 Leflunomide film coated tablets Leflunomide film coated tablet-10mg For additional indication- active psoriatic arthritis in adults only. 30/08/2004
3085 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
3086 Mecobalamine E.R. Tablet (1500mcg) For neuropathic pain. 19/07/2005
3087 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
3088 Misoprostol Tablet 600mcg Additional strength. 09.01.09
3089 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
3090 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
3091 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
3092 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
3093 Haemodialysis Powder/Liquid Form containing citrate For use for patients being treated by hemodialysis. 19.08.08
3094 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, acumř° 27-12-2000
3095 Lactulose powder for oral solution Each pouch contains; lactulose B.P-10gm,20gm Constipation 03/09/2001
3096 Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg Anti-epileptic. 08/06/2006
3097 Levocetirizem 2Hcl. Dispersible tablet (2.5mg) For allergic rhinitis & chronic urticaria. 08.05.07
3098 Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules For the treatment of vitamin deficiency states in adults. 14.01.09
3099 Nicotine polacrilex gum 30-04-2002
3100 Olmesartan Medoxomil (5mg/20mg/40mg) Tablet Each tablet contains; olmesartan medoxomil-5mg, 20mg, 40mg Anti-hypertension. 21/07/2005
3101 Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets For the treatment of adult patients with peripheral neuropathy. 09.02.10
3102 Verteporfin powder for solution for infusion 15mg vials 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
3103 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
3104 Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) As approved 07.05.07
3105 Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet Anti-biotic. 08/06/2006
3106 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
3107 Buprenorphine hcl + Naloxone sublingual tablets Each sublingual tab contains; buprenorphine hcl eq.to bprenorphine-2mg, naloxone hcl eq.to naloxone-0.5mg 2004-August
3108 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
3109 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
3110 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
3111 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
3112 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 ratř° 10.02.10
3113 Metoprolol tartrate tablets 50 mg (Addl. Indication) Adjunct to the treatement of Hyperthyroidism. 14.01.09
3114 Ursodeoxycholic Acid (600mg) S.R Tablet UDCA (600mg) sustained release. For treatment of i) primary billiary cirrhosis & ii) gallstones 20/07/2005
3115 Valsartan + S(-) amlodipine Each hard gelatin capsule contains; valsartan-80mg, s(-)amlodipine (as besylate)-2.5mg By RMP- for treatment of hypertension. 2003-November
3116 Cimetropium Bromide tablet 50mg For the treatment of irritable bowel syndrome. 31.01.08
3117 Collagen fleece For surgical procedure. 03/02/2000
3118 Combipacks (triple chambered bag) of aminoacid+electrolytes' dextrose (15% & 30%) and IV fat emulsion(LCT/MCT 20% w/w) By RMP 2003-November
3119 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
3120 Efavirenz tab Each film coated tab contains; efavirenz-600mg Higher strength 30-04-2002
3121 Etodolac ER tablets 400mg/500mg Each extended release tablet contains; etodolate-400mg, 500mg For the treatment of osteoarthritis & rheumatoid arthritis. 08.05.07
3122 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
3123 Levonorgestrel tabs Each tab.in packs of 2 tabs contain; levonorgestrel-0.75mg Emergency contraception in women. 06/09/2001
3124 Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate3.33mg per 5ml For symptomatic treatment of constipation in adults. 29.01.09
3125 Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) Anti-HIV 08/06/2006
3126 Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Pack size) Same as approved 10.02.10
3127 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 findinř° 05.04.11
3128 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
3129 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
3130 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
3131 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
3132 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
3133 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
3134 FDC of Ambroxol + guaiphenesin Each tab contains; ambroxol hcl-30mg, guaiphenesin-200mg For cough & congestion. 10/09/2001
3135 Stanozolol Each tablet contains; Stanozolol-2mg 1973-March
3136 Glycopyrrolate + neostigmine inj. Each 5ml contains; glycopyrrolate-500mcg, neostigmine methyl sulphate-2500mcg Reversal of residual non-depolarising competitive neuromuscular block. 11/04/2002
3137 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
3138 Ketorolac Tromethamine Ophthalmic Solution 0.45% Indicated for the treatment of pain and inflammation following cataract surgery. 10.02.10
3139 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
3140 Olopatadine Ophthalmic solution( 0.1%) For allergic conjunctivitis. 08/06/2006
3141 Quetiapen fumarate Sustained Release Tablets 50mg and 100mg (Additional Strength) Same as approved 05.04.11
3142 Ranolazine 1000mg ER Tabs (Additional Strength) Same as approve 31.01.09
3143 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
3144 Biomesh' GTR barrier (biodegradable) An aid to promote regeneration and integration of peridontal tissue components after surgical procedure. 01/12/1999
3145 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 ř° 10.02.10
3146 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
3147 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
3148 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
3149 Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. For iron deficiency anemia. 08/06/2006
3150 Fluvastatin sodium 25-11-2003
3151 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
3152 Piroxicam transdermal patch
3153 Rimonabant tablet 20mg For Obese Patients BMI‚?• 30kg/m2 or overweight patients BMI‚?• 27kg/m2 with Associated risk factors such As type-I diabetes or dyslipidemia. 11.05.07
3154 Sertaconazole Nitrate Cream 2%, For the topical treatment of the superficial mycosis like dermatophytosis. 31.01.08
3155 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
3156 Bambuterol hcl (bulk locally) (D.F 22-4-94) Bronchospasm in asthma, reversible air ways disease. 13-12-1999
3157 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) Treatmř° 31.01.09
3158 Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength) Same as Approved. 31.01.08
3159 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
3160 Clotrimazole lozenges Clotrimazole-10mg For local treatment of oropharyngeal candidiasis in immuno compromised patients. 13-03-2000
3161 Ezetimib tabs Each tab contains; ezetimib-10mg By RMP only- for the treatment of primary hypercholesteromia homozygus familial hypercholesterolemia. 17-12-2003
3162 Lactilol monohydrate Syrup 66.67/100ml Each 100ml syrup contains; lactilol monohydrate BP-66.67gm For the treatment of constipation. 16.05.07
3163 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
3164 Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg) + Entacapone (200mg) tablet For Parkinson‚??s disease. 25/07/2005
3165 Metronidazole colon drug delivery system Each tab contains; metronidazole-400mg New formulation- for treatment of intestinal amoebiasis & giardiasis in adult patients. 14-05-2002
3166 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
3167 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
3168 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;eař° For peritoneal dialysis. 25-09-2001
3169 Bulaquine compound 80/53 (local bulk mfg),(D.A.R 25-5-87) For vivax malaria only. 21-12-1999
3170 Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form ) Same as approved 20.04.11
3171 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
3172 Ebastine tab & bulk Each tab (film coated) contains; ebastine-10mg For Seasonal & prennial allergic rhinitis & chronic idiopathic urticaria. 28-09-2001
3173 Enoxaparin sodium inj. For additional indication: prophylaxis of deep vain thrombosis. 16-03-2000
3174 Glibenclamide + Metformin SR tablets Glibenclamide-2.5mg,5mg, metformin-500mg 20/08/2004
3175 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
3176 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
3177 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
3178 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
3179 Saquinavir (as mesylate) 500mg Tablet Addl.Strength. 25/07/2005
3180 S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate) 2.5/5mg For essential hypertension 16.05.07
3181 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
3182 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
3183 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
3184 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
3185 Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) As loading dose for prevention of in-stent restenosis in PCI. 22/06/2006
3186 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 coronř° 20.04.11
3187 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
3188 Combipack of Desogestrel and Ethinyl estradiol for oral contraceptive in women only. 29/05/2000
3189 Glimepiride + rosiglitazone Glimepiride-1mg, rosiglitazone-4mg For the treatment of type-II NIDDM. 12/12/2003
3190 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
3191 Lornoxicam 4mg + Paracetamol 500mg film coated tablets For the short term use in acute painful & inflammatory conditions in adults. 05.02.09
3192 Ofloxacin ER tab Each tablet containing ofloxacin-400mg, 800mg By RMP- for LRTI, complicated UTI, uncomplicated skin, soft tissue infections. 20-09-2001
3193 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 Parkinson‚??s disease. 25/07/2005
3194 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
3195 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
3196 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
3197 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
3198 FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule For Hypercholesterolemia. 26/07/2005
3199 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
3200 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
3201 Halobetasol 0.5mg + Miconazole 20mg per gram Cream For steroid responsive dermatoses associated with superficial fungal infection of skin. 31.01.08
3202 Leflunomide tab Each film coated tab contains; leflunomide-10mg,20mg,100mg For active rheumatoid arthritis in adults only. 01/10/2001
3203 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
3204 Levofloxacin 0.5% Ear drops For otitis media. 27/06/2006
3205 Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets For the treatment of patients with acute painful musculoskeletal conditions. 12.02.10
3206 MMR Vaccine 29-03-2000
3207 Montelukast tablets Montelukast-4mg,8mg,10mg For additional indication- relief of symptoms of seasonal allergic rhinitis in adults only. 2004-September
3208 Acarbose tablets Each tab contains; acarbose-50mg,100mg Insulin dependent (type-II) diabetes inadequately controlled by diet/or oral hypoglycaemic agent. 06/03/1997
3209 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
3210 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 ř° 27.08.14
3211 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
3212 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
3213 Amoxycillin Trihydrate Each dispersible tablet contains; Amoxycillin Trihydrate eq to 125mg of amoxycillin 1980-March
3214 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
3215 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
3216 Blonanserin Tablet 2mg/4mg/8mg For the treatment of Schizophrenia in adult patients when first line treatment is ineffective. 24.04.12
3217 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
3218 Carbamazepine C R tablets Each C.R film coated tablet contains; carbamezepine-200mg,400mg 17/05/1993
3219 Carnecaine with Adrenaline injection Carnecaine 2% with adrenaline, carnecaine 4% with adrenaline 1987-February
3220 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
3221 Chlorpheniramine maleate USP Each sustained release tablet contians; Chlorpheniramne Maleate USP-8mg 1978-April
3222 Chlorphenoxamine Embonate Each 5mL syrup contains; Chlorphenoxamine Embonate-17.5mg 1979-March
3223 Collagenase ointment Each gm contains; collagenase-250 units In the treatment for debriding chronic dermal and severely burn areas. 05/05/1994
3224 Dinoprostone (PGE2) Each tablet contains; dinoprostone (PGE2)-0.5mg For the induction of labours. 1990- February
3225 d-Norgestrel Each coated tablet contains; d-Norgestrel-0.03mg Oral contraceptive 1974-April
3226 Doxazosin mesylate Each uncoated tablet contains; doxazocin mesylate eq,to doxazocin-1mg,2mg,4mg Mild to moderate hypertension only 11/03/1999
3227 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
3228 Frusemide + KCl Each tablet contains; frusemide-20mg, potassium chloride-750mg 1989-March
3229 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 Ař° 07.05.15
3230 Gentamicin sulphate 0.8mg/kg, 0.4mg/kg Urinary tract infection. 1968- July
3231 Halobetazol Propionate Cream (0.05%) Corticosteroid responsive dermatomes. 02.02.07
3232 Hydroflumethiazide + rauwolfia i) HFT-25 + R-50, ii) HFT-50 + R-50, iii) HFT-25 1971- March
3233 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
3234 Lamivudine(40mg) + Nevirapine(70mg) + Stavudine(10mg) (in5ml)powder for suspension Anti HIV. 28/01/2005
3235 Levodopa 200mg + Carbidopa 50mg C.R. tablet For Parkinson's Disease. 08.01.08
3236 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, Etř° 1981-August
3237 Lynestrenol Progesterone hormone 1964- January
3238 Marcaine adrenaline marcaine-0.25% with & without adrenaline, marcaine-0.5% with or without adrenaline 1972- September
3239 Methacycline Hcl. Antibiotic 1966- December
3240 Methocarbamol 1gm to 1.5gm (Max. 4gm/day) Skeletal muscle relaxant. 1961- February
3241 Nalidix acid 500 mg tablets Urinary tract infection. 1969- April
3242 Nifedipine capsules Each capsule contains; nifedipine USP-10mg, 5mg 1984-December
3243 Niflumic acid Each capsule contains; Niflumic acid-250mg Anti-inflammatory drug- indicate in the treatment of rheumatoid arthritis, osteoarthritis. 1975- April
3244 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
3245 Norethisterone + Ethinyl oesteadiol Each tablet contains; Norethisterone-1mg, Ethinyl oesteadiol-30mcg 1977-June
3246 Norethyndrol 2.5 mg & Mestranol 0.1 mg 145-155 mg tabs (21 tablets) Oral contraceptive 1967- April
3247 Olanzapine Each film coated tab contains; olanzapine-15mg Additional strength 18-01-2002
3248 Oxacillin sodium 250mg caps New synthetic penicillin-use in Staphy. Resistance cases. 1963- April
3249 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
3250 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 panř° 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
3251 Penfluridol tablets Each tablet contains; penfluridol-20mg Long acting neuroleptic- Indicated in the treatment of schizophrenia etc. 1988-March
3252 Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.¬† 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) as¬† follows:¬†¬†‚?Ę Patients with unstable angina (UA) ř° 28.05.10
3253 Propanidiol 5% solution Local anaesthetic 1970- May
3254 Rilmenidine tablets Each tablet contains; rilmenidine dihydrogen phosphate eq.to 1mg of rilmenidine (base). Mild to moderate hypertension. 21/02/1995
3255 Semduramicin sodium 5% premix Each kg of premix contains; semduramicin-50gm (eq.to semduramicin sod.) 04/03/1998
3256 Thiocolchicoside tablets Each tab contains; thiocolchicoside-4mg 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. 25/03/1996
3257 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
3258 Triamterene Diurectic 1965- February
3259 Trimethoprim tablets Each tablet contains; trimethoprim-100mg 1983-June
3260 Trypsin-Kallikrein inactivator 2-3 ampoule i.v, 4-6 amp daily Inactivates trypsin & Kallikrein-indicated in pancreatitis. 1962- February
3261 Urokinase for inj. Thrombolytic agent- Indicated in the treatment of pulmonary embolism and thrombo embolic disorders involving deep veins. 1982-May
3262 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
3263 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
3264 Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication) For surgical prophylaxis (additional indication). 18.05.07
3265 Clarithromycin 1% gel Each tube contains; clarithromycin-1% Acne vulgaris 12/06/2002
3266 Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection For the treatment of acute colicky pain in adult patients. 28.04.11
3267 FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule Anti-histaminic & mucolytic. 29/07/2005
3268 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
3269 Gemcitabine in combine with cisplatin For additional indication 2003
3270 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
3271 Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution For the treatment of dandruff. 09.02.09
3272 Montelucast 10mg + Levocetirizine 5mg film coated tablets For the treatment of allergic rhinitis in adults only. 31.01.08
3273 Olmesartan 40mg + Hydrochlorthiazide 25mg tablet (addl. Strength) Anti-hypertensive. 28/06/2006
3274 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
3275 Amifostine injection Sterile lyoplillized powder for injection Shelf life extended 24 months to 36 months. 2004
3276 Buclizine HCl tablet (25mg) & Syrup 6mg/5ml As appetite stimulant. 28/06/2006
3277 Celecoxib Mouth Dissolving Tablet 50/100/200 mg For the Treatment of Osteoarthritis and Rheumatoid Arthritis. 25.02.10
3278 Cerivastatin tab Each tablet contains; cerivastatin sodium-100mcg,200mcg,300mcg By RMP- primary hypercholesterolemia type IIa, IIb resistant to diet. 11/05/2000
3279 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
3280 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
3281 Halobetasol Scalp Approved 0.05% w/v For the relief of inflammatory andpuritic manifestation of corticosteroidrespensive dermatosis. 18.02.09
3282 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
3283 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
3284 Lacosamide Syrup15mg/ml (Additional Dosage Form) Same as approved 02.05.11
3285 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
3286 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
3287 Hydroquinone 2% + Tretinoin 0.05% + Hydrocortisone 1% Cream For the treatment of patients with skin hyperpigmentation. 23.02.09
3288 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
3289 Atenolol 25mg/50mg + Indapamide SR 1.5mg For essential hypertension. 21.05.07
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 1% 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-50mř° 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 treatmeř° 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)-‚?• 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 ratř° 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, blotiř° 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 SeO2-1ř° 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 ‚?• 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 Synř° 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 29-10-200ř° 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 ‚?? treatment of advanced renal cell carcinoma after failure of one prior systemic therapy‚?Ě. 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, anř° 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 NNRTř° 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 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
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 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 Endometriatř° 20.05.11
3474 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
3475 Trandolapril tablets (bulk+ formulation) Each tablet contains; trandolapril-1mg,2mg,4mg RMP only- for the treatment of mild to moderate hypertension. 03/10/2003
3476 Valdecoxib + Paracetamol Valdecoxib-20mg, paracetamol-500mg RMP- for treatment of acute pain in adults only. 20/09/2004
3477 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
3478 Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for children) As approved 08.06.07
3479 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
3480 Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment For plaque psoriasis. 20/07/2006
3481 Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule (Additional Strength) Same as approved 31.05.11
3482 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
3483 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
3484 "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
3485 Insulin lispro mixtures (rDNA) inj. Already approved for different mixtures, diabetes mellitus. 31-07-2000
3486 Lidocaine Lozenges 200/300mg For single agent anesthesia in upper gastro intestinal endoscopy. 26.02.09
3487 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
3488 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
3489 Amlodipine 10mg/10mg + Telmisartan 40mg/80mg Tablets (Additional Strength) Same as approved 31.05.11
3490 Calamine 8% + Liquid Paraffin10% lotion As antipruritic and smoothening agent. 26.02.09
3491 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
3492 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
3493 Drosperinone 3mg + Ethinyl Estradiol 0.02mg tablets For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication). 16.03.10
3494 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
3495 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
3496 Moclobemide film coated tablets, bulk Tablets of moclobemide-150mg,300mg By psychiatrist- major depression & social phobia. 28-07-2000
3497 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
3498 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
3499 Oxcarbazepine tablets 2004-September
3500 Sodium Hyaluronate Injection (1%) For OA. 26/07/2006
3501 Amphotericin B emulsion injection Each ml of the emulsion contains; amphotericin B IP-5mg Indicated for the treatment of visceral leishmaniasis. 29/08/2003
3502 Cefditoren pivoxil 400mg tablets (Additional Strength) Same as Approved. 11.03.08
3503 Cefuroxime axetil extended release tablets Each ER tablet contains; cefuroxime axetil eq.to cefuroxime-500mg,1000mg 2004-October
3504 Desogestrel tab Each film coated tab contains; desogestrel-0.075mg Oral contraception in women only 20-08-2002
3505 Feracrylum (1%) + Metronidazole (1%) Each gm of gel contains; feracrylum-1%, metronidazole-1% An antiseptic gel for topical application. 05/10/2005
3506 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
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