Year 1971-1998 - Central Drugs Standard Control Organization
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Approval Status of New Drug during 1971-1981 S. No Drug Indication Date of Approval 1. Hydroxyurea USP Tablet 200 mg Anti-neoplastic agent Jan,1971 2. 2-thymyl-oxy-methyl glyoxalidine hydrochloride Nasal Spray - Jan,1971 3. 4. Hamycin Suspension Ferrous Sulphate Sustained Release Tablet 150 mg - Jan,1971 Jan,1971 5. Hydroxyurea USP Capsules, 500mg Anti-neoplastic agent Jan,1971 6. Ibuprofen BP Tablets, 50 mg Anti-rheumatic Mar,1971 7. Hydroflumethiazide Tablet 25 mg - Mar,1971 8. Chlorphenoxamine Hydrochloride Tablets 12 mg - Mar,1971 9. Epsilon amino caporic acid Injection 250 mg - Mar,1971 10. Ibuprofen BP Tablets, 200 mg Anti-rheumatic Mar,1971 11. Beverine Hydrochloride Tablets, 50mg Musculotropic & Spasmolytic Mar,1971 12. Panchromium Bromide Injection, 4mg/ml - Apr,1971 13. Ephedrine Sulphate Sustained Release Capsule 75 mg - May,1971 14. L-dihydroxyphenylalanine Tablet/Capsule 500 mg - May,1971 15. 16. 17. 18. 19. Rifampicin USP Tablets, 450mg Quinestral Tablets, 25mcg Ketamine Hydrochloride Glybenclamide Tablet 5 mg Mebeverine Hydrochloride Tablet 100 mg Anti-T.B. Estrogenic Steroid Anesthetic agent Muculo-tropic spasmolytic Jun,1971 Jul,1971 Aug,1971 Sep,1971 Oct,1971 20. Para-aminomethylbenzoic acid Injection 50 mg - Oct,1971 21. 22. Dihydroxyacetone Lotion Lactobacillus Sporengenes Tablet, 50/100 million - Oct,1971 Oct,1971 23. 24. 25. 26. 27. Yeast Tannic Acid Compound Cephalexin Salbutamol Sulphate BP Pheiramine Maleate Tablet Propranolol Hydrochloride Tablet 10 mg Anti-diarrheal agent Broad Spectrum Antibiotic Bronchial Asthma - Oct,1971 Oct,1971 Oct,1971 Nov,1971 Nov,1971 28. - Nov,1971 29. Propranolol Hydrochloride Injection 1 mg/ml Tetranicotinoyl Fructose - Nov,1971 30. 31. Spiramycin Injection Testolactone - Nov,1971 Nov,1971 32. Tetranicolinoyl Fructose Tablets 250 mg Prednisolone I.P Tablets 10 mg 3,5-Dinitro-o-toluamide Fenfluramine Hydrochloride Clopidal Testolactone Tablets 50 mg - Dec,1971 Anti-obesity drug Coccodiosis - Dec,1971 Jan,1972 Jan,1972 Jan,1972 Mar,1972 - Apr,1972 39. Fenfluramine Hydrochloride Tablets 20 mg Ferric Sodium Citrate - Apr,1972 40. 41. 42. Prothionamide B.P. Sarcolysin I.P. Doxepin Hydrochloride Anti-T.B. Drug Anti-cancer drug Psychotic Drug Jun,1972 Jun,1972 Jul,1972 43. Biperiden Hydrochloride Parkinsonism Jul,1972 44. 45. Anti-Helminthic Psychotic Drug Jul,1972 Sep,1972 46. 47. Pyrantel Pamoate U.S.P. Doxepin Hydrochloride Tablets/Capsule/Dragee 2-Bromo-2-nitropropan-1,3-diol Bupivacine Hydrochloride Preservative Local Anesthetic Sep,1972 Sep,1972 48. Fluphenazine Deconate Antipsychotic Sep,1972 49. Marcaine 0.25 %/0.5% with or without adranaline Propranolol Hydrochloride Chloramphenicol Biperiden lactate Injection 5 mg - Sep,1972 Parkinsonism Oct,1972 Oct,1972 Oct,1972 Cyclandelate Povidone Iodine Solution 10 % Povidone Iodine Gargle 0.5 % Ferrous Sulphate Sustained Release Tablet 160 mg Lithium Carbonate Capsule 250 mg Vasodilating Agent - Oct,1972 Nov,1972 Nov,1972 Nov,1972 - Nov,1972 Oxyclozamide Sodium chromoglycate Doxycycline Hydrochloride Tablet 100 mg Vertinary Drug Anti-asthmatic - Nov,1972 Nov,1972 Dec,1972 33. 34. 35. 36. 37. 38. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. 62. 63. 64. 65. 66. Isopropylthioimidazolidione Tablet 5 mg Lincomycin Hydrochloride Capsule 500 mg Mitomycin C Injection 2 mg Dec,1972 Dec,1972 Dec,1972 Parkinsonism Anti-cancer drug 67. 68. Amantadine Hydrochloride Daunorubicin Cyproheptadine Hydrochloride Tablet 4 mg Trifluperidal Hydrochloride Ethacrynic Acid U.S.P 69. 70. Beclomethasone Dipropionate Xantinol Nicotinate Tablet 500 mg Topical corticosteroid Feb,1973 Feb,1973 71. Bronchial Asthma Feb,1973 Vasodilating Agent Non-thiazide saluretic diuretic Feb,1973 Feb,1973 74. 75. 76. 77. Salbutamol Sulphate BP Tablet 4 mg Cyclandelate Tablet 200 mg Ethacrynic Acid U.S.P Tablet 25mg/ 50 mg Parbendazole Ethacridine Lactate Stanozolol Tablet 2 mg Oxyfedrine Treatment of Helminthiasis Anti-diarrheal Coronary Vasodilator Feb,1973 Feb,1973 Mar,1973 Apr,1973 78. L-Asparginase Anti-cancer drug May,1973 79. 80. Sutures May,1973 May,1973 83. Polyglycalic acid sutures Trifluperidal Hydrochloride Injection 1 mg/ml Trifluperidal Hydrochloride Tablet 0.25mg/0.5mg Trifluperidal Hydrochloride Oral liquid, 5mg/5ml Nitrazepam 84. 85. 86. 87. 88. 89. 90. Oxyprenolol Hydrochloride Fluraltadone Oxprenolol Hydrochloride Furaltadone Carbencillin Sodium Lincomycin Syrup 250 mg/5ml Prenylamine lactate Tablet 60 mg Beta-blocker 91. Oxyfedrine Tablet 8 mg Coronary Vasodilator, for angina pectoris, myocardial infarction & coronary insufficiency. 72. 73. 81. 82. Non-thiazide saluretic diuretic Dec,1972 Dec,1972 Jan,1973 Feb,1973 Feb,1973 May,1973 Neuroleptic agent May,1973 Jun, 1973 β Blocker Antibiotic Jun,1973 Jun,1973 Jun,1973 Jun,1973 Jun,1973 Jun,1973 Jun,1973 Jul,1973 92. Oxyfedrine Solution 10 mg Coronary Vasodilator, for angina pectoris, myocardial infarction & coronary insufficiency. Jul,1973 93. Oxyfedrine Injection 2 mg/ml Coronary Vasodilator, for angina pectoris, myocardial infarction & coronary insufficiency. Jul,1973 94. Tetramisole Hydrochloride 30% w/w 95. 96. Furaltadone powder 20 % w/w Alphachymotrypsin injection 5mg/vial 97. Pentazocine Tablet 50 mg 98. Morantel tartrate 99. Carbencillin Sodium Injection 1 g vial 100. Lorazepam 101. Fluphenazine Deconate Injection 2mg/ml 102. Nitrazepam Tablet 5 mg 103. Lyndiol Injection 104. Pindolol 105. Nitroxazepine Hydrochloride Injection 25 mg/2ml 106. Nitroxazepine HydrochlorideTablet 25 mg 107. Pindolol Tablet 5 mg 108. Aprotonin 109. Bleomycin 110. Carbenoxolone sodium Jul,1973 poultry disease only Aug,1973 Aug,1973 Antibiotic Aug,1973 Aug,1973 Aug,1973 Psychiatric drug Antipsychotic Sep,1973 Sep,1973 Anti-epileptic Sep,1973 Beta-blocking agent Sep,1973 Sep,1973 Sep,1973 Oct,1973 Beta-blocking agent Acute Pancreatitis Anti-cancer drug Gastric Ulcer Nov, 1973 Nov,1973 Dec,1973 Dec,1973 Psychiatric drug Topical anti-inflammatory steroid Dec,1973 Dec,1973 Dec,1973 114. Thiophanate 115. Carbenoxolone sodium Tablet 50 mg 116. Aprotonin Injection 100000 KIU/5ml, 200000KIU/10ml Vertinary Anti-Helminthic Gastric Ulcer Dec,1973 Jan,1974 Acute Pancreatitis Jan,1974 117. Meglumine Locarbate 118. Tinidazole Tablets, 150 mg X-ray contrast media For treatment of trichomoniasis and intestinal ameobisis Feb,1974 Feb,1974 111. Malathion dusting powder 1% 112. Lorazepam Tablet 1mg, 2 mg 113. Betamethasone-17-benzoate 119. Clomiphene Citrate B.P. Tablet, 50mg 120. Nitrofurantoin BP sensitivity disk 100 mcg/200 mcg 121. D-Norgestrol Tablet 0.03 mg Induction of ovulation in patients with persistent ovulatory dysfunction who desire pregnancy Feb,1974 Mar,1974 Oral contraceptive Apr,1974 122. Beclomethasone Dipropionate 0.025% cream & ointment 123. Lidoflazine Tablets, 60mg Topical corticosteroid Apr,1974 Indicated in treatment of ischemic heart disease and prophylaxis and after treatment of myocardial infarction May,1974 124. Sodium Fusidate Ointment, 20mg/gm For treatment of staphylococcal infections such as abscesses, varicose ulcer. May,1974 125. 6 aminopenicillanic acid Capsule, 250 & 500 mg For treatment of respiratory track, GI tract & Genital Urinary Tract infections. May,1974 126. Tretinoin 0.05% Vanishing cream Jul, 1974 127. Tretinoin 0.05% lotion 128. Tretinoin 0.05% sewab 129. D-pencillamine Tablets, 300mg Jul, 1974 Jul, 1974 Jul, 1974 130. Mesterolone Tablet 10 mg 131. Pimozide In the treatment of Metallic poisoning Wilson’s diseases In the treatment of potency disturbances, infertility & hypogonadism Jul,1974 In the treatment of chronic schizophrenia For treatment of acute and chronic UTI - Aug, 1974 For treatment of onychomycosis, dermatophytosis and vulvovaginitis. Oct,1974 135. Salbutamol Sulphate Elixir 2mg/5ml - Oct,1974 136. Mebendazole Tablets, 100mg For treatment of enterobiasis ascarissis trichuriasis ancylostomiasis strongyloidiasis large round worm whipworm hookworm & threadworm Nov,1974 132. Oxolinic acid 133. Isoptin Hydrochloride Injection 5 mg/ 2ml 134. Miconazole Sep, 1974 Sep,1974 137. Bupivacaine Hydrochloride Hyperbaric solution 10mg/ml 138. Pimozide Tablet 1mg, 4 mg Anesthetic Dec,1974 Neuroleptic agent & anti-psychotic agent Topical anti-fungal & anti-bacterial agent Indicated in the treatment of induction of labor for various reasons and for adequate uterine actions Dec,1974 141. Virginiamycin Indicated for growth proportion in poultry pigs and for prevention and treatment for swine dysentery. Feb,1975 142. Extract of centella asiatica Indicated in treatment of ulcers, burns, strain grafts, bed sores etc. Feb,1975 143. Niflumic acid Indicated in rheumatoid arthritis, osteo arthritis Indicated in treatment of hypertension - Feb,1975 - Mar,1975 Indicated in the treatment of various types of neoplasia both acute and chronic leukemia lymphomata. Soft tissue sarcomata breast and lung cancer. Mar,1975 Apr,1975 149. Betahistine Dihyrochloride Indicated in the Treatment of meniers syndrome characterized by uni- & bilateral tinnitus, vertigo usually accompanied by sensorineural hearing loss Apr,1975 150. Clotrimazole Indicated against certain bacteria, protozoa and against certain organisms which are sensitive to metronidazole May,1975 151. Inj. Of a mixture of sod. Salt & methyl glucamine salt of 3,5diacetamido-2,4,6-triiodobenzoic acid X-ray contrast media May,1975 152. Clotrimazole Vaginal Tablets 0.1 gm Anti-fungal & Local anti-trichomanial agent Jun,1975 139. Miconazole Cream 2% 140. Desamino-oxytocin 144. Clonidine 145. Testolactone Injection 100 mg/ml 146. Nitroglycerine Sustained Release tablet 2.6 mg 147. lynestrenol BP Tablet 2.5 mg 148. Doxorubicin hydrochloride Injection 10 mg/vial Dec,1974 Dec,1974 Feb,1975 Mar,1975 153. Clotrimazole 1gm/100gm cream Anti-fungal & Local anti-trichomanial agent Anti-fungal & Local anti-trichomanial agent Antibiotic Antihypertensive Jun,1975 Antihypertensive Jul,1975 158. Carbadox Indicated in the treatment of swine dysentery and bacterial enteritis. Jul,1975 159. Desoximetasone Indicated in management of various acute and chronic dermatitis viz eczema, nummular eczema infantile eczema, atopic dermatitis. Jul,1975 160. Alphachymotrypsin Tablet 25 chg units 161. Dimetridazole 162. Sodium Fluaride BP Tablet 20 mg - Jul,1975 Growth promotant in poultry - Aug,1975 Aug,1975 - Aug,1975 Topical anti-fungal & anti-bacterial agent Topical corticosteroid Aug,1975 154. Clotrimazole 1gm/100ml Solution 155. Virginiamycin 2% premix 156. Clonidine Hcl Tablet /Capsule 100 mcg 157. Clonidine Hcl Tablet 150 mcg 163. Urea 30 % solution for Intraamniotic use 164. Miconazole Nitrate Powder 20 mg/gm 165. Malathion lotion 0.5 % 166. Desoximetasone Ointment 2.5mg/gm 167. Pentoxifylline Jun,1975 Jul,1975 Jul,1975 Sep, 1975 Sep,1975 Indicated in the treatment of arteril and aterio venous circulatory disorders Sep,1975 168. Sodium Chloride 20% Hypertonic saline for Intra-amniotic use - Oct,1975 169. Trofosfamide Indicated in treatment of lymphogranulomatosis, lymphosarcoma reticulosacrcimo ovarian carcinoma, and carcinoma of breast. Nov, 1975 170. Pentoxifylline Dragee 100 mg 171. Pentoxifylline Injection 100mg/5ml Vasodilating Agent Vasodilating Agent Nov, 1975 Nov, 1975 172. Beclomethasone Dipropionate MDI 50 mcg 173. Cephradine - Dec,1975 Indicated in treatment of infections of GI, Gentio urinary, respiratory and soft tissue. Jan,1976 174. Mefenamic acid Indicated in treatment of acute and chronic pain, post-operative and post-partum pain, headache, traumatic pain, muscular pain. Jan,1976 175. Catalin (Sodium 1-hydroxy-5-oxo5H-Pyrido(3.2-a) phenoxazine-3carboxylate) Indicated in the treatment of cataract Jan,1976 176. Glydiazinamide Indicated in treatment of diabetes Feb,1976 177. Cephradine Capsule 250/500 mg Antibiotic Mar,1976 178. Cephradine Injection 250mg/500mg/1g/vial 179. Cephradine Suspension 250/5ml Antibiotic Mar,1976 Antibiotic Mar, 1976 180. Metronidazole Suspension 125 mg/5ml 181. Extract of centella asiatica 2% injection 182. Extract of centella asiatica 200 mg Tablet 183. Extract of centella asiatica Ointment 1% 184. Extract of centella asiatica Powder 2% 185. Oxibendazole premix 1.33% w/w - Apr,1976 Treatment of ulcers, strain grafts, bed sores Treatment of ulcers, strain grafts, bed sores Treatment of ulcers, strain grafts, bed sores Treatment of ulcers, strain grafts, bed sores Indicated in the treatment of gastrointestinal mematodes, infection of cattle, sheep, horses and other domestic animals. May, 1976 186. Aminosidine Sulphate Inj. Vial, 500mg Indicated in the treatment of styphylo coccus sepsis, infection of respiratory tract due to styphylo coccus and pneumo coccus infection of the urinary tract due to E coli, P vulgaris, gonococcus infections. Resistant to other antibiotics. May, 1976 187. Clonidine Hcl Injection 150mcg/ml Antihypertensive Jun, 1976 188. Halcinomide Indicated in the treatment of various common dermatosis - 189. Dexchloropheniramine maleate Tablet 2 mg 190. Trofosfamide Tablet 50 mg 191. Metronidazole Suspension 200 mg/5ml Anti-cancer drug - May, 1976 May, 1976 May, 1976 May, 1976 Jul,1976 Jul,1976 Aug, 1976 Aug,1976 192. Disodium chromoglycate Nasal drops 2% 193. Valethamate bromide 194. Asiaticoside 195. Loperamide - Sep,1976 Indicated in acute diarrhea due to food poisoning and viral infections. Nov,1976 Nov,1976 Dec,1976 - Dec,1976 Anti-emetic Indicated in the treatment of sinusitis, pharyngitis, sour throat, laryngitis, bronchitis, prevention of respiratory complication Dec,1976 Jan,1977 199. Flupenthixol Indicated in psychiatric or schizophrenic cases where sedative and hypnotics effects are contra indicated Jan,1977 200. Isometanidium Chloride Indicated in treatment of cardiac arrhythmias including atrial fibrillation, ventricular tachycardia, arrhythmia Jan,1977 201. Iron Polymaltose eq to Elemental Iron Drops 50 mg/ml 202. Flupentixol Hydrochloride Tablet 0.5 mg 203. Fusafungin aerosol 25 mg 204. Loxitalmic Acid - Feb,1977 - Feb,1977 Fungal Antibiotic cerebral angiography and urography (X-ray contrast media) Mar,1977 Apr, 1977 205. Dothiepin Hydrochloride Indicated in treatment of psychotic depression neurotic depression, anxiety depression May, 1977 206. Norethisterone BP Tablet 0.35 mg - May,1977 207. Disopyramide Capsule 100 mg - Jun, 1977 208. 1-(2-tetrahydrofuryl)-5-flourouracil Indicated in treatment of cancer of stomach, colon, rectum, breast & lung. Jun, 1977 209. Fluphenazine Deconate Depot Injection 20 mg/ml 210. Cyclandelate Capsule 200 mg 211. Nimorazole Antipsychotic 196. Tetramisole Hydrochloride Syrup 50mg/5ml 197. Metclopramide 198. Fusafungin 212. Suramin Inj. Vasodilating Agent Indicated for treatment of trichomoniasis veterinary Drug Jul,1977 Jul,1977 Sep, 1977 Sep, 1977 213. Doxapram Hydrochloride For treatment of post-operative respiratory depression and respiratory depression due to poisoning Sep,1977 214. Sulfinpyrazone Tablet 100 mg - Sep,1977 215. Sulfinpyrazone Capsule 200 mg - Sep,1977 216. Ethacridine lactate Injection 1mg/ml - Oct, 1977 217. Nimorazole Tablet 250 mg Indicated for treatment of trichomoniasis - Oct, 1977 - Nov,1977 Nov,1977 Indicated in treatment of allergic pruritus and inflammatory dermatosis Dec,1977 222. Beta-methyl Digoxin - Dec,1977 223. 2-Pyrrolidone Acetamide Indicated in treatment for behavior and psychotic problems in old age and mental retardation in children Dec,1977 224. Diazepam Injection 5mg/ml 225. Gentamycin Injection 2 mg/ml 226. Fluprednylidine 21-Acetate Cream 0.1% 227. 2-Pyrrolidone Acetamide Capsule 400 mg 228. 2-Pyrrolidone Acetamide Injection 200mg/ml 229. Diethylamine Salicylate Cream 10% w/w 230. Beta-methyl Digoxin Tablet 0.1 mg & 0.05 mg 231. Beta-methyl Digoxin Liquid 0.6 mg Topical Corticosteroid Dec,1977 Jan,1978 Jan,1978 Psychotic Drug Jan,1978 Psychotic Drug Jan,1978 - Mar,1978 Cardiac glycoside Mar,1978 Cardiac glycoside Mar,1978 232. Beta-methyl Digoxin Injection 0.1 mg 233. Methyl predinsolone Cardiac glycoside Mar,1978 Indicated for conditions requiring glucocorticoid activity including collagen diseases allergic diseases, hyper sensitivity reactions Mar,1978 234. N-phenylethylanthranilic acid Capsule 300 mg - Apr,1978 218. Pentazocine Lactate Injection 30 mg/ml 219. 5-Fluorouracil Capsule 250 mg 220. Orphenedrine Citrate Injection 60mg/2ml 221. Fluprednylidine 21-Acetate Oct,1977 235. Chlorpheniramine maleate USP Sustained Release Tablet 8 mg 236. Sulphametopyrazine - Apr,1978 The drug in combination with pyrimethamine for the treatment of cases of malaria which are resistant to chloroquine Jun, 1978 237. Flavonoids Extracted from Rutacea (Aurantiaceae) containing standard amount of Diosmin Indicated in the treatment of Hemorrhoids Jun, 1978 238. Miconazole Nitrate Vaginal Passary 100 mg 239. Soyabean Protein 33.2 g/150 g 240. Salcatonin 241. Dicloxacillin Sodium - Jun,1978 Polypeptide hormone Indicated in infection of respiratory tract, skin & mucosa, bone infection. Jun,1978 Jul, 1978 Jul, 1978 242. Sotalol Indicated in treatment of angina pectoris. Hyper tension cardiac arrhythmias Aug, 1978 243. Diazoxide Indicated for reduction of blood pressure in malignant hypertension Aug, 1978 244. Povidone Iodine USP Scrub 4% - Sep, 1978 245. Povidone Iodine USP Solution 5% - Sep, 1978 246. Povidone Iodine USP Ointment 5% - Sep, 1978 247. Ifosfamide Indicated in the treatment of ovarian breast testicular carcinoma hypernaphroma, pancreatic carcinoma and malignant lymphoma Sep,1978 248. Zinc Sulphate IP Capsule 220 mg - Sep,1978 249. Human Placental Extract Injection - Sep,1978 250. Indapamide Hemihydrate Tablets, 2.5mg 251. Glucagon Injection For mild to moderate hypertension Oct, 1978 Indicated in the treatment of severe hypoglycemic reactions in diabetic patients Oct, 1978 252. Amitryptylline Hydrochloride Tablet 75 mg 253. Oxymetazoline Hydrochloride 0.25% (Paediatric) - Oct,1978 Oct,1978 254. Bleomycin Injection 5 mg 255. Metronidazole Injection IV 2mg/ml Anti-cancer drug - Oct,1978 Nov,1978 256. Choline Salicylate solution 8.7% - Nov,1978 257. Doxapram Hydrochloride Injection 20mg/vial 258. Amoxycillin - Nov,1978 Indicated in treatment of UTI, Respiratory, Genito Urinary, ENT & soft tissue infections Dec,1978 259. Benorylate Treatment of headache, body ache, fever, rhinitis sinusitis Dec,1978 260. Mebendazole Suspension 100 mg/5ml 261. Trichlormethiazide Tablets, 2mg Broad Spectrum Antibiotic Dec,1978 In the treatment of hepatic cirrhosis, edema hypertension. Dec,1978 262. Cralanthamine Hydrobromide Tablet & Injection Treatment of neuritis, poliomyelitis & infantile cerebral palsies Dec,1978 263. Benorylate Tablet 250 mg 264. Benorylate Suspension 2g/5ml 265. 5-Fluorouracil Oral Solution 250mg/5ml 266. Salbutamol Sulphate Injection 50mg/5ml 267. Amoxycillin Capsule 250mg & 500mg Analgesic & Anti-pyretic Analgesic & Anti-pyretic - Dec,1978 Dec,1978 Jan,1979 Bronchial Asthma Jan,1979 Antibiotic Jan,1979 268. Amoxycillin Syrup 125mg/5ml & 250mg/5ml Antibiotic Jan,1979 269. Amoxycillin Paediatric Suspension 125mg/1.25 ml Antibiotic Jan,1979 270. Imipramine Pamoate Capsule 75 mg/ 150 mg 271. Naproxen Tablets 250 mg Indicated in the treatment of all forms of depression Indicated in treatment of rheumatoid arthritis Jan,1979 272. Allergen extracts 273. Fenbendazole 274. Chlorphenoxamine Embonate Syrup 17.5mg/5ml Indicated in treatment of gastrointestinal nematodes infections of live stocks Jan,1979 Jan,1979 Jan,1979 Mar, 1979 275. Carboprost Tromethamine Sterile Solution 250 mcg/ml 276. Miconazole Nitrate Solution 2% 277. Ifosfamide Injection 200mg/500mg/1g/vial 278. Clemastine For treatment of second trimester abortions only Treatment of rhinitis urticaria, pruritus itching dermatoses Apr, 1979 279. Isoxuprine Hydrochloride Sustained Release Tablet 40 mg - Apr,1979 280. Ibuprofen Suspension 100mg/5ml - Apr,1979 281. Oxyfedrine Tablet 24 mg - Apr,1979 282. Niflumic acid Capsule 250 mg 283. Diosmin Tablet/Capsule 150 mg Indicated in treatment of hemorrhoids Antibiotic May,1979 Jun,1979 Indicated in rheumatoid arthritis, osteoarthritis and allied disorders Jul, 1979 286. Clopamide Tablet 20 mg Indicated in the treatment of edema of cardiac, hepatic or renal region and hypertension only. Jul, 1979 287. Sodium Nitroprusside USP Injection 50mg/vial 288. Desoximetasone Ointment 0.05% - Jul,1979 Topical corticosteroid Jul,1979 - Aug,1979 Antibiotic Aug,1979 Antibiotic Aug,1979 - Aug,1979 Indicated in treatment of vaginal irritation and discharge due to monilial, trichomonial infection Sep, 1979 Indicated of treatment of Psoriasis contact dermatitis, atopic dermatitis, neuro dermatitis senile pruritus Sep, 1979 284. Amoxycillin Injection 250mg/500mg/1g/vial 285. Flurbiprofen Tablet 50 mg & 100 mg 289. Tetracycline Sustained Release Capsule 250 mg 290. 6 aminopenicillanic acid Injection 250 & 500 mg 291. 6 aminopenicillanic acid Oral Suspension 125mg/5ml, 250mg/5ml 292. Dicloxacillin Sodium Capsule 125 mg & 250 mg 293. Natamycin cream 2% 294. Betamethasone Dipropionate Ointment 0.5mg/g Mar, 1979 Mar,1979 Mar,1979 Jun,1979 295. Silver Sulphadiazine Cream 1% w/w Indicated in treatment of burns and wound infections Indicated in treatment of bronchitis and other conditions where sputum is troublesome Sep, 1979 297. Bromhexine Hydrochloride Elixir 4mg/5ml Indicated in treatment of bronchitis and other conditions where sputum is troublesome Sep, 1979 298. Amiloride HCl Tablet 5 mg Indicated in treatment of edema and hypertension - Sep, 1979 - Sep,1979 - Oct, 1979 302. Albendazole Suspension 2.5 % w/v & 10% w/v Indicated in control of Gastro Intestinal round warm, tap warm, lung warm and adult liver flukes in cattle and sheep’s. Oct, 1979 303. Terbutamine Sulphate Tablet 5 mg Indicated in treatment of asthma Nov, 1979 304. Terbutamine Sulphate Syrup 0.3 mg/ml 305. Dilazep Tablets 50 mg Indicated in treatment of asthma Nov, 1979 Indicated in treatment of coronary insufficiency, coronary sclerosis, angina pectoris as well as for prophylaxis and follow up treatment of myocardial infarction. Nov,1979 306. Terbutaline Sulphate Tablet 2.5 mg & 5 mg 307. Terbutaline Sulphate Syrup 0.3mg/ml 308. Glycopyrrolate Injection 0.2 mg/ml - Nov,1979 -- Nov,1979 Anesthetic agent Dec,1979 Indicated for treatment of hemodynamic imbalances present in the shock syndrome due to myocardial infraction, trauma endotoxic septicemia, open heart surgery and renal failure. Jan,1980 296. Bromhexine Hydrochloride Tablet 8 mg 299. Dioctyl Sodium Sulfosuccinate USP Ear Drop 5% 300. Dicloxacillin Sodium Oral Solution 62.5 mg 301. Natamycin Vaginal Tablets 25 mg 309. Dopamine HCl Injection 200 mg/5ml Sep, 1979 Sep,1979 310. Estriol Succinate Tablet 2 mg Indicated in treatment of local and general complaints arising from diminished estrogen production after menopause and after surgical removal of ovary. Mar, 1980 311. Amoxicillin Dispersible Tablet 125 mg 312. Salbutamol Sulphate Sustained Release Tablet 8 mg 313. Tylvalosin Tartarate - Mar,1980 Bronchial Asthma Mar,1980 Aid in treatment of chronic respiratory disease in chicken and for maintaining weight gain feed efficiency. May, 1980 314. Cimetidine Injection 100mg/ml Indicated for treatment of benign gastric duodenal recurrent and stomal ulceration, reflux esophagitis May,1980 315. Cimetidine Tablet/Capsule 200 mg Indicated for treatment of benign gastric duodenal recurrent and stomal ulceration, reflux esophagitis May,1980 316. Cimetidine Syrup 200mg/5ml Indicated for treatment of benign gastric duodenal recurrent and stomal ulceration, reflux esophagitis May,1980 317. Trimetazidine Dihydrochloride Tablet 3 mg Indicated in treatment of angina pectoris and intermittent claudication Jun, 1980 318. Cytrabine Injection Indicated in treatment of acute myeloid leukemia Indicated in treatment of breast cancer in pre and post-menopausal women Jun, 1980 319. Tamoxifen Citrate 320. Xipamid Tablet 40 mg 321. Halofuginone 322. Methicillin Sodium 323. Terbutaline Sulphate Injection 0.5 mg/ml 324. Levamisole Hydrochloride Injection 15% & 30% w/v 325. Levamisole Injection 18.2% w/v Jun,1980 Jul, 1980 For prevention and treatment of poultry coccidiosis indicated in treatment of infections due to penicillinase producing staphylococci Jul, 1980 - Jul,1980 - Jul,1980 - Jul,1980 Jul, 1980 326. Medrysone Ophthalmic Suspension 1.0% 327. Bumetionide Tablet 1 mg - Jul,1980 Indicated in treatment of edema associate with congestive heart failure, coronary edema, hepatic ascites and renal disease including nephortic syndrome Aug, 1980 328. Bumetionide Injection 0.25 mg/ml Indicated in treatment of edema associate with congestive heart failure, coronary edema, hepatic ascites and renal disease including nephritic syndrome Aug, 1980 329. Lomustine Capsule 10 mg, 40 mg & 100 mg 330. Quinpramine Sulphate 331. Quinpramine Chloride 332. Fenpipramide Methobromide and para-piperdinoethoxy ocarboxymethoxy benzophenol hydrochloride - Aug, 1980 - Aug,1980 Aug,1980 Oct,1980 333. Azatidine Maleate Tablet 1 mg 334. Flavoxate HCl Tablet 100 mg Anti-allergic For relief of dysuria urgency, nocturia, suprapubic pain, frequency, Incontinence prostatitis, urethritis, urethrotrigenitis, vaso urethral spasms. Nov, 1980 Nov,1980 335. Econazole Nitrate Cream 1% Topical Antifungal Dec,1980 336. Econazole Nitrate Vaginal Tablets 150 mg 337. Cephalothin Sodium Topical Antifungal Dec,1980 In the treatment of Infections of soft tissue, respiratory and urinary tract, meningitis, other infections due to susceptible organisms and in the treatment of infection due to penicillin resistant strains of staphylococci. Dec,1980 338. Plantago Ovata (Isapgol) seed husk (I.P) 339. Mesterolone Tablet 25 mg - Mar,1981 - Mar,1981 - 340. Ketoprofen Tablets/Capsule 50mg Indicated in the treatment of rheumatoid arthritis osteoarthritis, ankylosing spondylitis, gout. Apr, 1981 341. Sulphadoxine Indicated for the treatment of cases of malaria which are resistant to chloroquine Apr, 1981 342. Procarbazine For treatment of Hodgkin’s disease Apr, 1981 343. Inactivated rabies vaccine (Human Diploid cell) 344. Sisomicin Sulphate For the treatment of rabies. Apr, 1981 Indicated in treatment of and systemic and local infections of kidney, genito urinary tract, LRTI, septicemia, soft tissue infections, GIT infections, infection of CNS peritonitis or pelvic Apr, 1981 345. Tamoxifen Citrate Capsule 10 mg 346. Terizidone Apr,1981 Indicated in treatment of Tuberculosis Indicated in treatment of acute and chronic schizophrenia anxiety, neurosis, manic depressive psychosis & hyper kinetic children. Jun, 1981 348. Clindamycin Indicated in treatment of gram positive organism pathogen, staphylococci and streptococci, pneumococci etc. Oct,1981 349. Sodium Valporate Indicated in treatment of all forms of epilepsies Indicated in lumber thoracic cervical & total columnar myelography, direct ventriculography etc. Oct,1981 347. Azabiperidol 350. Metrizamide 351. Sodium-2-mercepto-ethane sulphonate Indicated for prevention of urotoxic side effects associated with treatment of malignant tumors by oxazaphosphorines Sep,1981 Nov, 1981 Dec,1981 Approval Status of New Drug during 1982-1992 S No Drug 1 Nitroglycerin ointment 2 Danazol capsule 100mg/200mg 3 5 Metoprolol Tartrate tablet 50 mg/100mg Cisplatin injection 10 mg/ 50 mg per vial Urokinase for Injection 6 Rosoxacin Capsules 150 mg 7 8 9 Magaldrate tab 400 mg Fenbendazole Measles Mumps Rubella Vaccine Ethacridine lactate 100 mg/ 200 mg Rifampicin syrup Trimethoprim tablet 100 mg Disopyramide inj. 100 mg/5 ml & 150 mg/7.5 ml Tinidazole suspension 75 mg/5 ml Ponderax SR tab.60 mg Nifedipine capsules 5 mg/ 10 mg Septopal Beads and Chains 4 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Timolol Maleate oph. Solution 2.5 mg/ml Flurazepam capsules 15 mg/ 30 mg Tonazoline HCl nasal drop 0.08% sol. Metoprolol inj. 1 mg/ml Praziquantel tablet 600 mg Nimustine HCl inj. 25 mg/ 50 mg per vial Carboquone tablet 0.25 mg/ 0.5 mg Carboquone inj. 1 mg/ vial Centbucridine inj. 0.5 % Etomidate inj.2 mg/ ml Cinnarizine tablet 25 mg/15 mg Indication Date of Approval For treatment of Angina Pectoris due to coronary artery disease Indicated in the treatment of endometriosis, gynaecomastia, fibrocystic mastitis, precocious puberty and pubertal breast hypertrophy Indicated in treatment of hypertension Jan-82 Indicated in the treatment of metastatic testicular and ovarian cancer Indicated in treatment of pulmonary embolism and thromboembolic disorders involving deep veins Indicated in treatment of gonorrhoeal Urethritis ---- Mar-82 Mar-82 Apr-82 May-82 Jul-82 Nov-82 Jan-83 Feb-83 -- Jun-83 ---- Jun-83 Jun-83 Aug-83 -- Dec-83 --- Sep-84 Dec-84 For treatment of Bones and Soft Tissue infections For treatment of Chronic Open angle Glaucoma , Ocular Hypertension -- Jan-85 Aug-85 Nasal Decongestant Aug-85 Jul-85 ---- Aug-85 Aug-85 Aug-85 -- Aug-85 ---- Aug-85 Aug-85 Aug-85 Aug-85 -- Aug-85 anaesthetic Mianserin HCl tablet 10/20/30 mg S No Drug Indication Date of Approval 30 Netilmicin sulphate inj. 10 mg/ 25 mg/ 100 mg per ml Aug-85 31 32 --- Aug-85 38 Spectinomycin hydrochloride 39 Tobramycin inj. 10/40 mg per ml 40 Monensin Sodium premix 41 Cefazolin Sodium inj. 250 mg, 500 mg & 1 gm. per vial 42 Diclofenac Sodium tablet 25/50 mg 43 Nadolol 44 Testosterone Undecanoate capsules 40 mg 45 Dextranomer sachet 4 gm. & 6 gm. per sachet 46 Serratio peptidase tablet 5 mg 47 Cimetidine inj. 100 mg/ ml Indicated in the treatment of CHD and anti-anginal -In the treatment of hypertension angina pectoris cardiac arrhythmias Indicated in the treatment of acute gonorrhoeal urethritis & proctitis in male and acute gonorrhoeal cervicitis & proctitis in female In the treatment of serious bacterial infections such as sceptical lower respiratory tract infections , serious central nervous system infections, abdominal l infections complicated and recurrent urinary tract infections & skin and bone infections In the treatment of Coccidiosis in chicken and hens In the treatment of serious infections due & susceptible organisms, respiratory tract infections urinary biliary tract infections. In the treatment of rheumatoid arthritis ,osteoarthritis ankylosing spondylitis gout, painful post operatic pain following dental surgery etc. In the treatment angina pectoris, cardiac arrhythmias and essential hypertension Indicated for replacement therapy in cases of hypogonadism and male climacteric in the treatment of gynaecomastia In cleansing secreting wounds like venous stasis ulcers, decubitus ,ulcers infected traumatic ulcers & infected tumours Indication for the remission of various inflammatory disorders including post-operative inflammation and traumatic injury. -- Aug-85 36 37 Ranitidine tablet 150 mg Hydrocortisone Butyrate cream/ ointment 0.10 % Mexiletine inj. 250 mg/ 10 ml Mexiletine capsules 50/150 mg Isosorbide Mononitrate tablet 20/40/60 mg Aminoglutethimide Atenolol tablet 50 mg/ 100 mg Indicated in the treatment of Septicaemia including neonatal sepsis and other severe systemic infections. --- 48 Econazole ophthalmic ointment 1% in treatment of fungal infection of the eye Sep-85 33 34 35 Aug-85 Aug-85 Aug-85 Sep-85 Sep-85 Sep-85 Sep-85 Sep-85 Sep-85 Sep-85 Sep-85 Sep-85 Sep-85 Sep-85 49 S No 50 51 Propranolol HCl SR tablets 80/160 mg Drug Bleomycin Oil Suspension injection. Ciclopirox Olamine solution/ cream 10 mg/ ml 52 Bacampicillin tablet 400 mg 53 Captopril tablet 25/50 mg 54 Ivermectin solution 10 % w/v and 1% w/v injection 55 Nicergoline sugar coated tablet,5 mg/ 30 mg 56 Amoxapine tablet 25/ 50/ 100 mg 57 Purified chick Embryo 58 amoseanate tablet 250 mg. 59 Satranidazole tablet 150 mg 60 Benserazide Hydrochloride 61 Acebutolol Hydrochloride capsule 100 mg/ 200 mg/ 400 mg 62 Acebutolol Hydrochloride injection 5 mg 63 Atracurium Dibesylate Injection 64 Sulprostone injection 65 Praziquantel tablet -- Sep-85 Indication Date of Approval Indicated in the treatment of cancer Indicated in the treatment of fungal infections of the skin and vagina. Indicated in the treatment of Upper & lower respiratory tract infections, urinary tract infection, skin infections, post-operative infections. Indicated in the treatment of hypertension only Indicated for the control of various helminthic infections such as round worm. Indicated in the treatment of acute chronic peripheral and cerebral vasculometabolic disorders, Raynaud's syndromes and all syndromes due to altered peripheral loss. Indicate for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions, depression accompanied by anxiety and agitation. Indicated for treatment after explosive of rabies for preexposure prophylaxis. Indicated in treatment of adult hookworm infestations. -- Sep-85 To be used only in the manufacture of capsules containing this drug in combination with Levodopa for the treatment of Parkinson’s disease. Indicated in the management of all grades of hypertension angina pectoris and control of tachyarrhythmia. Indicated in the management of all grades of hypertension angina pectoris and control of tachyarrhythmia. Indicated for use in anaesthesia to relax muscle during surgical procedures and to facilitate controlled ventilation. For second trimester abortions only In the treatment of infections brought about the larvae of the pork tapeworm in the Central Nervous Nov-85 Oct-85 Oct-85 Oct-85 Oct-85 Oct-85 Nov-85 Nov-85 Nov-85 Nov-85 Dec-85 Dec-85 Jan-86 Jan-86 Feb-86 system. S No Drug Indication Date of Approval 66 Albendazole tablet 200mg / 400 mg Albendazole suspension 200mg / 5 ml ranitidine injection 50 mg /2 ml Pentoxifylline dragees 400 mg infectious bursal disease vaccine Buserelin Acetate (Lutenizing Hormone) -- Feb-86 -- Feb-86 -- Feb.86 March.86 March.86 67 68 69 70 72 Buprenorphine 73 Receptal injection -For treatment of infectious bursal disease in poultry Indicated in the treatment of infertility of ovarian origin for the induction of ovulation and improvement of conception rate in cows, mares & rabbits. Indicated in the treatment of post -operative pain, premedication before surgery & myocardial pain. -- 74 Venoprin injection -- Apr-86 75 Noristerat injection Apr-86 76 77 78 79 Biclotymol Dynoprost inj. 5 mg Carboprost Tromethamine Lopamidol Sterile Sol 80 Iohexol Sterile Sol. 81 Medroxy progesterone acetate Tablet 82 Amikacin injection 83 Vecuronium Bromide 84 Luprostiol 85 Flutamide 86 Nitroglycerin injection Indicated for contraception Respiratory Infections, Bronchitis -Vet. Only Indicated in neuroradiology angiography urography arthrography etc. ( X-ray Contrast medium) Indicated in neuroradiology angiography urography arthrography etc. ( X-ray Contrast medium) Indicated in the treatment of secondary amenorrhea and functional uterine bleeding to hormonal imbalance only. Indicated in the treatment of serious infections due to amikacin sensitive organisms Indicated for use in anaesthetic to relax muscle during surgical procedures and to facilitate, contracted ventilation. Indicated in the treatment of corpora luteal, induction of abortion etc. Indicated for palliative treatment of advanced prostatic cancer only Indicated in the treatment of angina pectoris myocardial 71 Apr-86 Apr-86 Apr-86 May-86 May.86 May-86 Jun-86 Jun-86 Jun-86 Jun-86 Jun-86 Jun-86 Jun-86 Jun-86 infection etc. S No Drug Indication Date of Approval -Indicated in treatment of flatulence hyperacidity gastritis heart burn, dyspepsia etc. anti-cancer Jun.86 Jun-86 87 88 Gugulipid Hydrotalcite 89 Flutamide tablet 90 Prosolvine inj. 7.5 mg/ ml -- Jun-86 91 Estramustine Phosphate capsule Prednimustine tablet Jul-86 Jun-86 94 Polyestradiol Phosphate injection Epirubicin injection 95 96 Doxorubicin inj. 10 mg Tiamulin Hydrogen Fumarate 97 Piroxicam tablet 98 99 Tiamulin soluble granules Tiaprofenic Acid 100 Secadrex tablet Indicated in the treatment of prostatic carcinoma. Indicated in the treatment of chronic lymphocytic leukaemia, Non- Hodgkin’s lymphoma and breast cancer Indicated in the treatment of prostatic carcinoma In the treatment of breast cancer, Malignant lymphomas, soft tissue sarcoma gastric lung and ovarian carcinomas. -In the prevention and treatment of mycoplasma induced disease of the respiratory tract including complication due & secondary infections only (Vet. Use only). In the treatment of rheumatoid arthritis, osteo. Arthritis ankylosing spondylitis, cervical spondylitis and other musculoskeletal disorders. -In the treatment of post-operative period, sprains fracture various traumatic conditions. -- 101 Debriphor beads -- Aug-86 102 Articaine Hydrochloride Aug-86 103 104 Clobetasone -17- butyrate cream/ointment 0.05% Reproterol Hydrochloride 105 Clostebol acetate 106 Ketoconazole tablet 200 mg and Ketoconazole suspension 20mg/ml 107 ketoconazole vaccine(Killed) For Spinal infiltration dental surgical & epidural anaesthesia In the treatment of mild eczema, dermatitis and other steroid responsive disorders In the treatment of conditions involving reversible airways obstruction viz. bronchial asthma, bronchitis etc. Preparation containing the drug with Neomycin shall be indicated in the treatment of infected wounds and & 2nd degree burns. In the treatment of systemic fungal injections, candidiasis chronic mucocutaneous candidiasis Vaginal candidiasis etc. in the treatment of parvo-virus infections in 92 93 10 mg Jul-86 Jul-86 Jul-86 Jul-86 Jul-86 Aug-86 Aug-86 Aug-86 Aug-86 Sep-86 Sep-86 Sep-86 Oct-86 Oct-86 dogs only S No Drug 108 Canine Distemper 109 Sucralfate tablet 1 gm. 110 Propafenone Hydrochloride 111 Tiaprofenic Acid tablet 200 mg and 300 mg Centbutindole 112 113 114 115 Clobetasone butyrate creams/ointments 0.05 % Labetalol Hydrochloride Indication Date of Approval Vaccine against canine distemper parvovirus infectious canine hepatitis and leptospirosis. In the treatment of gastric duodenal and benign ulcer. Indication in the treatment of ventricular extra systoles supra ventricular tachycardia etc. -- Nov-86 Neuroleptic agent Dec.86 -- Indication in the treatment of all forms of hypertension ( except Hypertension of pregnancy) -- Nov-86 Nov-86 Dec.86 Dec.86 Dec-86 117 Propofenonen tablets 150 mg/ 300 mg Propofenonen injection 70 mg/ 20 ml ampoule Repreterol tablet 20mg 118 Repreterol syrup 10mg/ 5 ml -- Jan.87 119 Labetalol Hydrochloride tablet 50 mg/ 100mg/ 200 mg Hepatitis B Vaccine -- Jan.87 116 120 121 122 124 Centbutindole tablets 1.5 mg Carbocaine injection 2 % -20 mg Sulprostone injection 500 mcg/ ampoule Bleomycin Injection 125 Clavulanic Acid 126 Trazadone 127 128 Infectious coryza vaccine Polidocanol Injection 129 Tobramycin ophthalmic solution 0.03% per vial Acyclovir Tablets/ Cream/ Ointment/ Ophthalmic Ointment 123 130 131 S Cefotaxime Sodium injection 0.25, 0.5, 1 and 2 gm./ vial Drug Jan.87 -- Jan.87 -- Jan.87 For treatment of hepatitis B virus infection Jan.87 --- Feb.87 Feb.87 -- Feb.87 Indication in the treatment of prostatic carcinoma ,breast cancer, melanoma and carcinomas of the head neck and lungs To be used in combination with Amoxicillin only in the treatment of Bacterial injections Indicated in the treatment of all types of depression -Indicated in the treatment of sclerosation of various cutaneous veins and oesophageal varicose haemorrhoids haemangioma -- Feb-87 Indicated in the treatment of herpes simplex virus infections of the skin including initial and recurrent genital herpeslabialise herpes simplex keratitis -- Indication Feb-87 Mar-87 Marc.87 Mar-87 April.87 May-87 Jun-87 Date of No 132 133 Approval Diclofenac sodium injection 75 mg/ 3 ml ampoule Diltiazam 134 Alclometasone Dipropionate cream/ointment0.05% 135 Trazodone tablet 25 mg/ 50 mg/ 100 mg Bromocriptine Mesylate tab. 2.5 mg, 5 mg and 10 mg 136 137 Carbocisteine 138 139 140 141 Nova-T Flumequine Stanozolol injection 50 mg/ ml Neutral insulin and Insulin Zinc suspension Broncospasmin tablet 20 mg Broncospasmin elixir 10 mg/ 5ml Broncospasmin respiratory solution 10 mg/ml Broncospasmin injection 0.09 mg/ml Clobetasol Propionate cloxacillin benzathine intramammary infusion 500 mg Rabies Veterinary Vaccine(inactive) Domperidone tablet 10 mg , oral drops 10 mg/ml and suspension 10 mg/ml, rectal suppositories 30 mg Norfloxacin tablet 400 mg/ 800 mg and ODT 100 mg 142 143 144 145 146 147 148 149 150 151 152 Influenza Vaccine Ozothine tablet 60 mg 153 Ozothine syrup 60 mg /5 ml 154 Auranofin capsules 3 mg 155 156 Chenodeoxycholic acid Buprenorphine sublingual tablets 0.2 mg Propranolol HCL SR capsules 80 mg Measles, mumps and rubella vaccine 157 158 -- Jun-87 Indicated in the treatment of angina pectoris and chronic stable angina only Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatomes -- Jul-87 In the treatment of prolactin dependent menstrual cycle disorders female infertility pre-menstrual syndrome hyper prelactinoma in men. . Indicated as an adjunctive therapy in respiratory disorders IUD RTI -In the treatment of insulin requiring diabetes by inj. or infusion --- Jul-87 Jul-87 Jul-87 Aug-87 Aug-87 Sep-87 Sep.87 Sep-87 Oct. 87 Oct. 87 -- oct.87 -- Oct. 87 --- Oct-87 Oct.87 -- Nov-87 Indicated in the treatment as gastric motility disorder etc. Nov-87 In the treatment as acute uncomplicated/complicated chronic, recurrent urinary tract injections including pyelonephritis cystitis, urethritis & gonococcal infections. For treatment of influenza in equine In the treatment of acute chronic infections of respiratory tract.. In the treatment of acute chronic infections of respiratory tract.. In the treatment of rheumatoid arthritis and in children with Juvenile rheumatoid arthritis. --- Nov-87 -- Dec.87 -- Dec-87 Nov-87 Dec-87 Dec-87 Dec-87 Dec-87 Dec.87 159 Etoposide Capsule 160 161 162 163 Diclofenac Sodium SR Tab. 75/100mg Bezafibrate Amineptine Astemizole 164 165 166 Budesonide Penfluridol tablet 20 mg Aclarubicin HCl 167 Etoposide injection 100mg/ 5 ml ampoule Zidovudine Capsules 168 169 170 Silver sulphadiazine eye ointment. 1% Ceftriaxone sodium 171 172 Minoxidil Benzydamine topical analgesic 173 Interferon alpha injection 174 Melagenina Lotion 175 Amrinone Lactate 176 Ethamsylate tablet 250 mg/ 500 mg 177 Minocycline 178 180 181 Alprazolam tablets 0.25 mg/0 .5 mg/ 1 mg Cefuroxime injection 250 mg/ 500 mg / 1 gm. per vial Tertatolol Hydrochloride Cyclosporine 182 Ceftazidime Pentahydrate 183 Gemfibrozil Capsules 300 mg /900 mg 184 185 Astemizole Susp. Triclabendazole 186 187 Cephalexin tablet 1gm Rabies vaccine(inactivated) 179 In the treatment of small cell lung cancer, malignant lymphomas acute etc. -- Jan-88 In all form of hyper lipoproteinaemia. In the treatment of all types of depression In the treatment of allergic rhinitis allergic conjunctivitis chronic urticaria & other allergic conditions. In the treatment of bronchial asthma In the treatment of schizophrenia etc. In the treatment of acute leukaemia, malignant lymphoma, stomach, lung cancer etc. -- Jan-88 Jan-88 Feb-88 In the treatment of short term management of serious man infestation of human immuno deficiency virus (H.I.V) injection in patients. -- Apr-88 Indicated in the treatment of UTI, lower respiratory tract infections. In the treatment of male pattern baldness In the treatment of musculo-skeletal pain only In the treatment of multiple myeloma hairy cell leukaemia etc. Re-pigmenting treatment of skin in depigmented of areas of in patients suffering from vitilgo. For the short term management of congestive heart failure In the treatment of small vessel haemorrhage menorrhagia (including IUD users) prophylaxis of periventricular haemorrhage is neonates. In the treatment of UTI, respiratory, skin, soft tissue, ENT injections. In the treatment of anxiety associated with depression In the treatment of respiratory tract injection UTI, ENT soft-tissue injections. In the treatment of hypertension Indicated in immuno suppression in organ transplants For UTI, respiratory ,skin, soft tissue GI infections etc. For the treatment of adult patients with very high triglyceryl levels (Type IV - hyper lipidemia) -In the treatment of chronic fasciola gigantica F. hepatica in sheep goats cattle and buffaloes. -For treatment after exposure to rabies and Apr-88 Jan-88 Feb-88 Mar-88 Mar-88 Mar-88 Apr-88 Apr-88 Apr-88 May-88 May-88 May-88 May-88 May-88 Jun-88 Jun-88 Jun-88 Jun-88 Jun-88 Aug-88 Aug-88 Sep-88 Oct-88 Nov-88 188 for pre-exposure prophylaxis For treatment after exposure to rabies and for pre-exposure prophylaxis In the treatment of all types of maturity onset diabetes without or with obesity in adults. Prevention of coccidiosis To be used in combination with Ethingloestradiol for contraception. In the treatment of gastric &duodenal ulcers 189 Purified chick Embryo Cell vaccine Gliclazide 190 191 Salinomycin premix 6% Desogestrel 192 Tri Potassium Dicitrate Bisulphate 193 Lipoproteins extracted from human placenta lotion 50% -- Jan-89 194 Salinomycin -- Jan.89 195 Cefadroxyl tablet/ capsule 500mg/ 1 gm 196 Cefadroxyl oral suspension 125/250 per 5 ml 197 198 KFD Vaccine Tripotassium Dicitrate Bisulphate Mitoxantrone HCl injection 2 mg 199 200 Equine Influenza 201 202 Anti-Rabies Vaccine Parvovirus vaccine 203 Carboplatin 204 Famotidine 205 Ciprofloxacin Hydrochloride Monohydrate tab 250/ 500/ 700 mg of Ciprofloxacin Hydrochloride Monohydrate infusion 100 mg/ 50 ml & 200 mg/100 ml Sodium Hyaluronate sol. 206 207 208 209 210 211 212 213 214 5-Aminosalicyclic acid Miconazole Eye drops 1% Flurbiprofen Eye drops 0.03% Ketoprofen CT Tab. 100mg Diltiazem SR Tab. 90/120mg Diltiazem MR Tab. 30/60mg Recombinant Human Tissue Type plasminogen activator Nov-88 Nov-88 Dec-88 Jan-89 Jan-89 In the treatment of UTI, skin & skin structure infections caused by S.coci or streptococci pharyngitis tonsillitis, respiratory tract infections only. In the treatment of UTI, skin & skin structure infections caused by S.coci or streptococci pharyngitis tonsillitis, respiratory tract infections only. --- Feb-89 In the treatment of acute non-lymphatic leukaemia, breast cancer non-Hodgkin’s lymphoma. Vaccine against influenza respiratory diseases, caused by EHI virus, prevention of abortion due & EHI virus infection. Vaccine against rabies Immunization as healthy dogs against canine parvovirus infections. Advance stage of ovarian cancer small cell carcinoma of lungs. In the treatment of duodenal & peptic ulcer Zollinger Ellison syndrome. Indicated in the treatment of respiratory tract infection UTI. Skin and soft tissue, severe systemic injections surgical. Indicated in the treatment of respiratory tract infection UTI. Skin and soft tissue, severe systemic injections surgical. To be supplied against to prescription of a ophthalmologist only -for fungal infection of eye ----To be supplied for use in Hospital, nursing times and against the prescription of specialist Mar-89 Feb-89 Mar-89 Mar-89 Mar-89 Mar-89 Mar-89 Mar-89 May-89 May-89 May-89 Jun-89 Jun-89 Jul-89 Jul-89 Jul-89 Jul-89 Jul-89 Jul-89 215 216 217 Desmopressin Nasal Sol/ Nasal Spray/ Injection Enalapril Maleate Piperacillin Sodium 218 Flavophospholipol 219 220 221 Nifedipine Sustained Release tablets 20 mg Purified chick Embryo vaccine Lofepramine 222 Haloperidol Deaconate 223 224 225 Naproxen Tablets Ranitidine syrup 150 mg/10 ml Ofloxacin 226 227 228 Dinoprostone tablet 0.5 mg Norfloxacin eye drops 0.3% Tinidazole Infusion 2mg/ml in 400 ml, 2mg/ml in 800ml Pentoxyphylline SR 229 230 231 232 233 Cyclo Pentolate HCl Ophthalmic Solution Tropic amide Sterile Ophthalmic Solution Ibuprofen CR Tab 600mg 235 236 Fluoxetine Hydrochloride Cap 20 mg Terbutaline Nebulising Solution Famotidine Injection Diazinon 237 Amiodarone HCl 238 Pinaverium Bromide 239 Piroxicam Gel 240 241 242 Trimethoprim powder 100gm Oxytetracycline injection200mg/ml Cefuroxime axetil 243 244 245 Ceftizoxime Deltamethrine Prazosin Hydrochloride 234 -- Aug-89 -In the treatment of systemic and local infections pre-operative infections prophylaxis, obstructive and gynae infection UTI neo-natal and life threatening paediatric infections. Used as feed additive in farm animals and poultry Farm-bird. -- Aug-89 Aug-89 -In the treatment of depressive condition only For the management of chronic schizophrenia --In treatment of respiratory tract infection, UTI ,Gynaecological Infections skin/soft tissue infection for the induction of labour -In the treatment of infections Dec-89 Jan-90 Indicate for purpose as for plane conventional dosage For mydriasis and cycloplegia Mar-90 for mydriasis and cycloplegia in diagnostic procedure For chronic arthritic disorder and painful musculoskeletal conditions for the treatment of depression Mar-90 for acute asthmas Mar-90 -In the treatment for control of ectoparasites in livestock Control of ventricular and supra ventricular arrhythmias where other drugs cannot be used including arrhythmias wolf Parkinson white Syndrome In the treatment of spastic colon, irritable bowel syndrome, biliary dyskinesia and for radiological investigation In the treatment of musculo-skeletal inflammatory disorders -treatment of anaplasmosis and their annulata infection for lower &upper respiratory tract injection upper UTI skin and soft tissue infection etc. ---- Apr-90 Apr-90 Sep-89 Nov-89 Feb-90 Feb-90 Feb-90 Feb-90 Feb-90 Feb-90 Mar-90 Mar-90 Mar-90 Mar-90 Apr-90 Apr-90 Apr-90 May-90 May-90 May-90 May-90 Jun-90 Jun-90 246 Flurbiprofen SR Cap. 200mg 247 Coligen 248 249 L- Carnitine Isoflurane 250 Iopromide 251 Prenoxdiazine HCl 252 Terfinadine 253 Loxapine 254 Buspirone HCl 255 Mometasone Furoate 256 257 Orthoclone Sterile Ribavirin 258 Flunarizine HCl 259 260 261 Salazopyrin Tab.ER 500mg Centchroman Tab. 30mg Xylazine HCl 262 263 264 Ciprofloxacin Hydrochloride eye drops 0.3% w/v Diclofenac Gel 1gm Cefaclor 265 Omeprazole 266 Nefopam 267 268 269 Butalex Idarubicin Hydrochloride Kitotifen 270 Pefloxacin Mesylate Dihydrate 271 272 Ofloxacin Infusion 2mg/ml Nitrendipine tablet 10/ 20 mg 273 Roxatidine Acetate HCl 274 Isosorbide mononitrate SR tab. 50mg Rabbit Anti Human Thymocyte 275 Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis for the prevention of calf scours, due to infection with enteropatho genic-Ecoli organism -Used for induction and maintenance of general anaesthesia Used as a contrast medium for uro-angiography Indicated in relief of cough of bronchial origin Allergic rhinitis allergic dermatological condition and other histaminic disorders. For the management of the manifestation of psychotic disorders. Indicated in the treatment of anxiety and tension states Steroid responsive dermatitis , eczema, or atopic dermatitis -acute hepatitis viral respiratory and herpes infection as a maintenance treatment for classical and common migraine for rheumatoid used as sedative Used as a sedative analgesic and muscle relaxant properties for use in horses, dogs, and cattle’s treatment of external ocular infection of the eye -In respiratory infection, ENT infection UT infections, skin and skin structure infections short term treatment of duodenal /gastric ulcers/reflux oesophtiagitis/management of zollinger Ellison syndrome Acute and chronic pain, including postoperative pain, dental pain, musculo skeletal pain, acute traumatic pain, and cancer pain. In the treatment of Bovine theileriosis -In prophylactic treatment of bronchial asthma, symptomatic improvement of allergic conditions including rhinitis. In the treatment of serve injection in adults caused by sensitive microorganism(gram ve pathogens and staphylococci) RTI, UTI, skin & soft tissue infection In the treatment of mild to moderate hypertension Disorders in the upper gastric intestinal i.e. duodenal ulcers benign gastric ulcers. prophylaxis of angina pectoris -- Jun-90 Jun-90 Jun-90 Jul-90 Jul-90 Jul-90 Sep-90 Sep-90 Oct-90 Oct-90 Oct-90 Nov-90 Nov-90 Nov-90 Nov-90 Nov-90 Feb-91 Mar-91 Apr-91 Apr-91 Apr-91 Apr-91 May-91 May-91 May-91 May-91 May-91 May-91 May-91 May-91 279 immunoglobulin Felodipine Pirarubicin HCl Injection Horse antihuman lymphocyte globulin Ramipril 280 Selegiline HCl 281 282 283 Piroxicam inj. 20mg/ml Perindopril Ethamsylate Inj. 250mg 284 Nilutamide Tablets 285 Lisinopril 286 Ofloxacin eye drops 3mg/ml 287 Clomipramine HCl tablets HCL 10 mg/ 25 mg/ 50 mg 288 Clomipramine HCl capsule 50 mg 289 Bisoprolol Fumarate 290 291 Amsacrine Injection Fucidic Acid hemihydrate 292 Sodium Enoxaparin 293 Roxithromycin 294 Metoclopramide CR Tab. 15mg 295 Ketorolac Tromethamine tablet 10 mg 296 Ketorolac Tromethamine injection 30 mg/ ampoule 276 277 278 In the treatment of hypertension -For aplastic Anaemia May-91 May-91 May-91 Indicated in the treatment of hypertension /cardiac failure and also for myocardial infarction. In the treatment of Parkinson’s disease Treatment of muscular skeletal disorders In the treatment of Hypertension Treatment of small vessel haemorrhage, menorrhagia, prophylaxis of periventricular haemorrhage in neonates. In the treatment of metastatic or localised cancer of the prostate Essential hypertension and in patients with congestive heart failure. treatment of external infections of the eye and to adnexa caused by susceptible bacteria Obsessive compulsive disorders, phobic states and depression (When sedation is required) Obsessive compulsive disorders, phobic states and depression (When sedation is required) Hypertension, coronary heart disease (angina pectoris) -Bacterial infection of the eye caused by susceptible organism in conjunctivitis blepharits keratitis, dacryocystitis It can be used for prophylaxis in ophthalmic surgery and in connection with removal of foreign bodies. As a prophylactic in the treatment of thromboembolic disorder during orthopaedic surgery, general surgery and haemodialysis. Sensitive strain infections of ENT. Bronchopul monary tract injection, genital except for gonocoecal. Infections prophylaxis of meningoco-ecal. Meningitis in exposed subject. to restore normal coordination and the together upper digestive tract and relieve symptoms of gastro duodenal dysfunction including heartburn, dyspepsia, nausea and vomiting associated with such conditions as reflux oesophagitis, gastritis, duodenitis and hiatus hernia In the treatment of short term management of post-operative pain and musco-skeletal pain In the treatment of short term management of post-operative pain and musco-skeletal Aug-91 Aug-91 Aug-91 Sep-91 Sep-91 Oct-91 Nov-91 Dec-91 Feb-92 Feb-92 Feb-92 Feb-92 Mar-92 Mar-92 Mar-92 Apr-92 Apr-92 Apr-92 297 298 299 300 Betaxolol Hydrochloride ophthalmic 0.5 %W/V/ 5 ml Oral Polio vaccine Gadopentetic acid dimeglumine salt injection 469.01 mg Pyridoxine HCl CR tab.100mg 301 Cephacetrile concentrated infusion 235 mg 302 Korsolex concentrated instrument disinfectant Sterillium rub in disinfectant for hands Bacillocid special Feracrylum Acid Polyelectrolyte Loratadine tablet 10 mg 303 304 305 306 307 Dexfenfluramine HCl capsule 15 mg 308 Bacillus calmette guerin vaccine 309 Candur P. Parvovirus 310 Naloxone HCL 311 Nimodipine tab 30 mg, inj.10mg/50 ml 312 Ginkgo Biloba film coated tab. 40 mg 313 314 315 316 317 Hamycin cream 0.1% Clindamycin Gel 1% Itrolan Pipecuronium Bromide Cisapride pain Ocular hypertension and chronic open angle glaucoma -Cranial and spinal magnetic resonance tomography May-92 May-92 May-92 Deficiency of vit. B6 caused by usage of oral contraceptive pill Mastitis caused by streptococcus agalactial STr dysgalactial, streuteris staphylococcus, aureus, (Both penicillin sensitive and resistant strain) gram (Negative)-ve bacterial including E Coli and klebsiella. -- May-92 -- May-92 --- May-92 May-92 In treatment of allergic rhinitis acute coryza chronic idiopathic urticaria. 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 behaviours (carbohydrate compulsion) To be indicated for intravesical use in the treatment of primary and relapse carcinoma in-situ of the urinary bladder. For active immunization of dogs against parvovirus infection for the complete partial reversal of narcotic depression including respiratory depression induced opioids including natural and synthetic narcotics, propoxyphene methadone, and certain narcotic -antagonist analgesics nalbuphine,pentazocine, are butorphenol In the treatment and prevention of ischaemic neurological deficit occurring due to arterial spasm following subarachnoid haemorrhage In the treatment of disorders in the functioning of the brain (reduced intellectual ability and alertness). Giddiness buzzing in the ears, head-ache poor memory, weakening of the voice resulting from anxiety. -acne vulgaris Contrast Medium -Gastro intestinal disorders Jun-92 May-92 May-92 Jun-92 Jun-92 Jul-92 Jul-92 Aug-92 Sep-92 Sep-92 Oct-92 Oct-92 Nov-92 Nov-92 318 Tetrachlorodecaoxide oxoferin 319 Tetrachlorodecaoxide Sol. 1.037 mg/100ml Ipratropium Bromide inhaler 20 mcg Benoxinate Hydrochloride oph. Solution 320 321 Tissue repair of wounds with impaired healing such as infected wounds, delayed post traumatic and post-operative wound healing and delayed healing after operation --For use as an anaesthesia of cornea and conjunctivitis for ophthalmic procedure. Nov-92 Nov-92 Nov-92 Nov-92 Approval Status of New Drug during 1993-1998 S.No Drug 1. Human Erythropoietin Injection 2. Tramadol Hydrochloride Injection 50 mg per 1 ml and 100 mg per 2 ml ampoule Ticlopidine HCL 250 mg tablet 3. Indication In the treatment of anaemia due to chronic renal failure and end stage renal disease Severe acute and chronic pain diagnostic measures and surgical pain. For the prevention of Cerebro and cardio vascular accidents in patient suffering from arterial insufficiency in the legs and cerebral vessels and correction of platelet disorder induced by extra corporeal circuits during surgery with extra cerebral circulation on haemodialysis (artificial kidney) In the treatment of UTI respiratory tract infection, biliary tract infection Anti-arrhythamic Date of approval Jan-93 27.01.93 11.02.93 4. Cefixime capsules 100mg/200mg/400mg 5. 6. Flecainide Acetate 100 mg Tablet & 150 mg/ml Fluconazole Capsules50mg/100mg/200mg/150mg and Fluconazole injection -2mg/ml 7. Tenoxicam tablet 20 mg 8. 9. 10. Benzafibrate retard tablet 400 mg Paspat injection Cisapride 11. Intestinal amoebiasis, amoebic hepatitis, trichmonial vaginitis, bacterial vaginitis and giardiasis. 13/May/9 3 12. SecnidazoleTablet and oral suspension (1. Each tab 500 mg/ 1000 mg ) and (2. Each 15ml suspension contains Secnidazole500mg, Amlodipine Besilate tablets 5/10 mg Indicated in hypertension, angina pectoris. 19/May/9 3 13. Mepartricin tablets 50000 Units 14. Nitroglycerin patch 25/50 mg Functional disorder in benign prostatic hypertrophy For the treatment of Angina pectoris due to coronary artery 28/May/9 3 3/Jun/93 For the treatment systemic candidiasis muscular candidiasis cryptococosis prevention of fungal infection in patients with malignancy. Rheumatoid arthritis, osteoarthritis, osteoporosis, ankylosing spondylitis, gout, nonarticular rheumatic conditions. --Management of dyspepsia 24.02.93 26/Mar/9 3 26.04.93 29/Apr/93 April/93 May/93 May/93 15. Cetirizine Dihydrochloride tablets5/10/20 mg 16. Maduramicin 1% w/w premix Vet 17. Itraconazole capsules -100mg 18. Glucomannan Sachets (herbal medicine) ( Each sachets containing Glucomannan-0.75gm/1.0.gm/1.3gm) Metronidazole (skin ointment) gel 1 % W/W Zalcitabine Film Coated Tablets 0.375mg/0.750mg Calcitriol Soft Gelatine Caps 0.5mcg & 0.25mcg 19. 20. 21. disease Seasonal rhinitis and conjunctivitis, perennial allergic rhinitis, pruritus and urticaria For the treatment as an aid for the prevention of coccidiosis in broiler chickens Systematic aspergillosis and candidosis, cryptococcosis, histoplasmosis, sportrichosis, paracoccidioidomycossis, blastomycosis and other rarely occurring systemic or tropical mycosis. For reduction of blood glucose level reduction serum lipid level 25/Jun/93 7/Jul/93 20/Jul/93 6/Sep/93 - 19/Jul/93 For the treatment of Aids 26/Jul/93 For the treatment of metabolic bone diseases 27/Aug/9 3 Treatment of impaired attentiveness, and/or memory or feelings of giddiness in elderly, painful symptoms of arterial disease, idiopathic Parkinson disease Indicated when parenteral therapy is necessary for inotropic support in the short term treatment of cardiac discompensation due to depressed contractility resulting either than organic heart disease or from cardiac surgical procedure. 27/Sep/9 3 22. Piribedil S.R. Tablets 50mg 23. Dobutamine HCL Inj. (infusion concentrate) 50 mg/ ml 24. Nicardipine capsules 20mg/30mg In treatment of hypertension and chronic stable angina pectoris 29/Oct/93 25. Flunisolide Nasal Spray 0.025% w/w For the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever. 30/Nov/9 3 26. Colfosceril Palmitate injection 108mg per vial New born babies with birth weight of 700gm or greater, undergoing mechanical ventilation of respiratory distress syndrome, whose heart rate and 1/Dec/93 4/Oct/93 arterial oxygenation are continuously monitored. 27. 28. 29. 30. Salmeterol Inhaler/Salmeterol Rotacap. (Each actuation deliversSalmeterol Xinafoate-25mcg Each Rotacaps contains Salmeterol xinafoate eql to Salmeterol-50mcg) Enrofloxacin 5% oral solution and injection [1. Each ml of Injection contains Enrofloxacin-100mg/50mg 2. Each ml of oral solution contains Enrofloxacin -50mg/100mg] Gadodiamide IV injection (Each Iml Injection contains-Gadodiamide 287mg equl to 0.5m mol (in 10ml vial) Ondansetron tablet: 4 mg /8 mg and injection: 4mg 2 ml & 8 mg/4 ml 31. LomefloxacinTablet 400mg 32. Azithromycin capsules/suspension [Each capsule contains : Azithromycin dihydrate equl to 250mg of base 2. Each 5ml contains: Azithromycin200mg/50mg] 33. Terconazole Vaginal ovule/vaginal cream [1. Each ovule contains: Terconazole- 80mg 2. Terconazole vaginal cream contains-Terconazole-0.8%.] Ioversol Injection 160, 240 , 300, 320, 350 Botulinum Toxin.A 100 unit [Each Vial contains Clostridium botulinum toxin type-A - Hemagglutinin Complex 100units. Human. Serum albumin0.5mg Nacl-0.9mg] Paclitaxel injection [5ml single dose vial contains-Paclitaxel-30mg] 34. 35. 36. 37. Esmolol HCl injection [1. Each 10ml ampoule contians: Long term regular treatment of reversible airway obstruction in asthma and chronic bronchitis 1/Dec/93 Vet drug 20/Jan/94 Contrast media 21/Jan/94 On the treatment and management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy In the treatment of mild to moderate infections caused by susceptible strains of designated micro-organism in R.T.I uncomplicated and complicated U.T.I. 1. In the treatment of mild to moderate susceptible infection including R.T.I., uncomplicated skin /skin structure, nongonoccoal urethritis cervicitis 2. For susceptible infection including community acquired pneumonia pelvic inflammatory diseases. For the local treatment of vulvo vaginal candiasis (moniliasis) 12/Feb/9 4 Contrast media 29/Dec/9 3 13/Jan/94 For the treatment of blepharaspasm hemifacial spasms assocaited focal dystonia Advanced epithelical carcini of the ovary after failure of first line or subsequent chemotherapy. Supraventricular tachycardia for rapid central of ventricular rates 20/May/9 4 13/May/9 4 19/Jul/94 25/Aug/9 4 26/Aug/9 4 2.5/gm of Esmolol HCl. 2. Each 10ml vial contains: 100mg of Esmolol HCl] 38. Genotropin 4IU/12IU/16IU injection 39. Chandonium Iodide injection2mg/ml 40. Sultamicillin Tab [Each film coated tablet contains: Sultamicillin( asTosylate)-375mg equl to sulbactam 147mg and Ampicillin 220mg)] 41. Collagenase Ointment 250 units 42. Closantel 15% oral solution 43. Celiprolol Hydrochloride tablets100mg/200mg/400mg Lansoprazole capsules 15 mg/30 mg 44. 45. 1. Nimesulide tablets 100 mg 2.Nimesulide suspension-50mg/ 5ml 3. Nimesulide Transdermal Gel-1% 46. Diclofenac sodium opthalmic solution sterile 0.1% (1mg/ml) 47. Terazosin Hcl tablet 1mg/2mg/5mg 48. Clonazepam tablets 0.5mg/1.0mg/2.0mg 49. Ritodrine HCL tablet and injection [Each tablet contains, Ritodrine HCL10mg, Ritodrine HCL Injection each ml contains-Ritodrine HCL-USP patients with atrial fibrillation or atrial flutter in per-operative, post-operative circumstances where short term control of ventricular rate is desirable Short stature due to inadequate or failed incretion of pituitary growth hormone. Neuro muscular blocking agent In the treatment of Intraabdominal infection obstetrics, and gynaecogicological infections, skin and soft tissue infection. Bone and joint infection, upper and lower respiratory tract infections, ENT infections, UTI , gonorrhoea and surgical prophylaxis. In the treatment for debriding chronic dermal and severely burn areas. Mature and immature fasciola species, haemonchus species, strongylodes species and also for external parasites like oestrus ovis boophilus microplus hyalomma a anatolicum in cattle and sheep. Mild to moderate hypertension, angina pectoris For the treatment of duodonal ulcer, gastric ulcer, reflex oesophagitis, zollinger ellison syndrome Inflammatory condition including joint disorder such as rheumatoid arthritis, post traumatic and postoperative painful condition and fever Indicated in post-operative inflammation in patients who have undergone cataract operation In the treatment of essential hypertension and BPH In the treatment of petitmal and its variant, akinetic and myoclonic seizures Premature labour, acute foetal distress, prevention of preterm labour after operations. 5/Sep/94 1/Mar/94 6/May/94 5/May/94 3/Oct/94 1/Dec/94 16.12.94 13/Jan/95 27/Jan/95 27/Jan/95 25/Jan/95 21/Feb/9 5 50. 51. 52. 53. 10mg] Rilmenidine Dihydrogen Phosphate tab. 1 mg Tromantadine HCl oinment 1 gm Ointment Permethrin cream 5% Clozapine tablets 25mg/100mg mild to moderate hypertension Herpes simplex infection of the skin Infection with sarcophytscabiec Indicated in the management of schizophrenic patients 21/Feb/9 5 23/Feb/9 5 6/Mar/95 7/Mar/95 54. Formestane Depot Injection (I.M.) 250mg For the treatment of advanced stage of breast cancer in women with natural or artificially induced post-menopausal status. 6/Mar/95 55. Altretamine caps -50mg 29/Mar/0 5 56. Etidronate-Disodium tablets 200mg 57. Terbinafine Tab. 250mg / cream 1% 58. Clarithromycin tablets -250mg/500mg 59. 60. Podophyllotoxin Topical solution [Each 3-5ml contains, Podophyllotoxin-0.5%] Silymarin tablet -70mg For palliative treatment of patient with persistent or recurrent ovarian cancer, following first line therapy with cisplatin and /or alkylating agent based combination. Hypercalcemia induced by various malignant disorders Fungal infection of skin, hair, nails of mild to moderately severe infection like acute exacerbation of chronic bronchitis community acquired pneumonia including infection due to chlamydia, mycoplasma spegiocella, acute streptococcal pharyngitis and skin & soft tissue infection Ano-genital warts non facial warts only 22/Jun/95 61. Lovastatin 10mg/20mg/40mg 62. Ambroxol tablet/liquid/drops [1. Each tab. Contains, Ambroxol HCL-30mg, 2. Each 5ml liquid contains, Ambroxol HCL-30mg, 3. Each ml drops contains, Ambroxol HCL-7.5mg] Gemcitabine Injection supportive treatment in chronic liver disease and cirrhosis Reduction of total LDL Cholesterol in patients of primary hyper cholesterolemia (Type IIa& IIb hyper lipo-proteinemia) Acute and chronic disease of the respiratory tract associated with abnormal bronchial secretions in particular acute attack of chronic bronchitis, asthmatic bronchitis, bronchial asthma. In the management of non-small cell lung cancer Acute migraine attacks with or without aura only where there is a clear diagnosis 24/Jan/96 63. 64. Sumatriptan tablets and injection [Each film coated tabs contains, 1. Sumatriptan (as succinate)- 10/Mar/9 5 29/Mar/9 5 22/Mar/9 5 5/May/95 5/Oct/95 1/Dec/95 6/Feb/96 65. 100mg/50mg/25mg 2. Sumatriptan injection contains Sumatriptan as succinate 6mg-per 0.5ml] Tacrine Hydrochloride caps 10mg/20mg/30mg/40mg 66. Nitroscanate tablets (VET) 100mg/500mg 67. Ketorolac Sterile Ophthalmic solution 0.5% 68. Fluticasone Propionate ointment 69. Piroxicam Betacyclodextrin tabs 20 mg 70. Thiocolchicoside tablet -4 MG 71. Sulbutiamine tabs -200mg 72. Benazepril Hcl tabs 5mg/10mg/20mg 73. Levobunolol Hydrochloride ophthalmic solution 2.5MG/5.0MG 74. Terlipressin Acetate Injection I.V. 1mg. Danofloxacin Mesylate injection (vet) 250 mg 75. 76. 77. 78. Salmon Calcitonin Injection [1. Each ampoule contains- Salmon Calcitonin100 IU/ml 2. Each vial contains-Salmon Calcitonin 400 IU/2ml.] Gabapentin caps 300mg/400mg Docetaxel injection concentration - For the treatment of dementia in patients with Alzheimer’s diseases of mild to moderate severity For control/eradication of Hookworm/Roundworm/Tapewor m in puppies and adult dogs for the relief of ocular itching due to seasonal allergic conjunctivitis only Inflammatory and pruritic manifestation of corticosteroid responsive eczema dermatitis Pain and inflammation associated with rheumatoid arthritis, osteoarthritis, acute musculo-skeletal pain, postoperative pain and primary dysmenorrhoea As an adjuvant treatment in painful spasms associated with degenerative vertebral disorder and vertebral static problems, torticollis, dorsal pain, low-back pain, traumatologilcal and neurological disorder. Symptomatic treatment of functional asthenia Essential hypertension and congestive heart failure For the control of intra-ocular pressure in chronic open angle glaucoma and ocular hypertension In the treatment of bleeding oesophageal varices. Bovine respiratory disease in beef cattle, non-lactating dairy cattle calves caused by pasteurella haemolytica P multocida and enteric infection caused by E.coli /salmonella sp. Hypercalcemia pain associated with advanced metastatic bone cancer, Paget’s disease, postmenopausal osteoporosis. 14/Feb/9 6 Epilepsy Indicated in the treatment of 3/Aug/95 20/Jun/96 19/Feb/9 6 1/Mar/96 18/Mar/9 6 25/Mar/9 6 25/Mar/9 6 23/Mar/9 6 22/Apr/96 16/May/9 6 22/Jul/95 28/Jul/95 3/Aug/95 80mg (2ml/vial) & 20mg (0.5ml/vial) patients with locally advanced or metastatic breast cancer and small cell lung cancer in the management of hypertension and also in the prophylactic management of patients with angina pectoris. 79. Carteolol Hcl tabs 5mg, 80. Carteolol Hcl opthalmic solution 2% w/v In ocular hypertension, chronic open angle glaucoma and some secondary glaucoma’s 9/Jul/96 81. In non-infected / infected inflammatory ocular condition 26/Jul/96 82. Fluorometholone 0.1% and Fluorometholone tarte liquifilm 0.25% opthalmic suspension Artemether Injection -80mg In severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only. 2/Aug/96 83. Artemether Capsule 40mg 3/Aug/96 84. Centpropazine caps -20mg In severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only. In the treatment of depression. 85. Benidipine Hcl tabs 4mg/8mg 86. Zopiclone 7.5MG tablet 87. Tibolone tablet 2.5mg 88. Cypermethrin High-cis (VET) 100mg 89. Promegestone tabs 0.125mg/0.250mg/0.500mg 90. Nicardipine retard caps. 40mg/30mg 91. Artesunate tabs 50mg Hypertension and long term prophylactic management of Angina-pectoris Short term treatment of insomnia, transient, situational or chronic insomnia and insomnia secondary to psychiatric disorders when it is debilitating or severe. In the treatment of complaints resulting from the natural or surgical menopause. for the control of ticks Gynaecological conditions characterised by luteal insufficiency menstrual irregularities due to ovulation disorders, dysmenorrhea, premenstrual syndrome, mastodynia, dysfunctional uterine bleeding menorrhagia du to fibromyomas, menopausal syndrome. management of hypertension and Angina pectoris Promoted for use in severe 9/Jul/96 16/Aug/9 6 12/Aug/9 6 16/Aug/9 6 16/Oct/96 16/Sep/9 6 23/Sep/9 6 9/Oct/96 7/Oct/96 92. 93. Finasteride tablets 5mg Naltrexone Hcl tabs 50mg 94. Sparfloxacin tabs. 100mg/200mg, 400mg 95. Ceftibuten Capsule/Suspension [Each capsules contains ceftibuten 200mg/400mg Each 5ml suspension contains ceftibuten 90mg/180mg ] Povidone-Iodine sterile ophthalmic prep solution 5.0% w/v 96. 97. Norfloxacin powder (vet) 10% 98. Ornidazole tablet and infusion[Each tab contains, Ornidazole-500mg,/ Ornidazole infusion-5mg/ml (100ml infusion bottle)] Nicorandil tabs 5mg/10mg/20mg 99. 100. Nicorandil injection 2mg/12mg/48mg 101. Arteether injection I.M. -150mg per vial 102. Creatine Phospate Inj [Each vial contains creatine phospate 500mg/1g] 103. Moxidectin inj (vet) 1% w/v malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only Benign prostatic hypertrophy only In the treatment of narcotic antagonist and alcohol dependence. Community acquired pneumonia, acute exacerbation of chronic bronchitis, other lower respiratory tract infection caused by susceptible bacteria, acute sinusitis, gonococcal and nongonococcal urethritis in males, uncomplicated UTI, skin, soft tissue infections, ENT infections. 9/Oct/96 11/Oct/96 11/Nov/9 6 Upper respiratory tract infection, lower respiratory tract infection, UTI and enteritis and gastroenteritis. 19/Nov/9 6 for prepping of the periocular region and irrigation of the ocular surfaces Wide Variety Of Infections Caused By Susceptible Gram+Ve And Gram-Ve Organism Including Mixed Infection In Poultry In the treatment of susceptible protozoal infection and anaerobic bacterial infection only 22/Nov/9 6 For the prevention and long term treatment of angina pectoris For the prevention and long term treatment of angina pectoris Promoted for use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only Deficient striated muscle activity, Co-adjuvant in the treatment of myocardial disorders, for addition to cardioplegic solution as a means of protection in heart surgery. In the treatment and control of internal and external parasites in cattle. 10/Jan/97 12/Mar/9 7 13/Jan/97 23/Mar/9 9 14/Jan/97 20/Jan/97 16/Jan/97 104. Mefloquine Hcl tabs 250mg 105. Acarbose tabs 50mg/100mg 106. Resperidone tabs 1mg/2mg/3mg/4mg 107. Resperidone Liquid 1 mg / ml 108. Glipizide GITS Tabs 5mg/10mg 109. Etodolac tablet & Capsules [Each tab contains Etodolac BP-200MG/400MG Each caps contains Etodolac-300mg ] 110. Artesunate injection 60mg 111. Midazolam injection BP 1mg/ml & 5mg/ml 112. Polyvidone eye drops 5% 113. 114. Lacidipine tabs 2mg/4mg Pyrazinamide dispersible tabs -250mg 115. Adenosine injection 6 mg /2ml Use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only non-insulin dependent type II diabetes inadequately controlled by diet and / or oral hypoglycaemic agents acute and chronic schizophrenic psychoses and other in psychotic conditions in which positive symptoms and negative symptoms are prominent acute and chronic schizophrenic psychoses and other in psychotic conditions in which positive symptoms and negative symptoms are prominent Non-insulin dependent diabetes mellitus (Type-II) Inflammation and painful conditions in osteoarthritis, acute attacks of gout and pseudo gout pain following dental extraction, post-operative and post episiotomy pain, dysmenorrhoea, and acute musculoskeletal pain. Promoted for use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only 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. Symptomatic treatment of dry eye conditions including keratoconjunctivitissicca mild to moderate hypertension Short course treatment of tuberculosis in pediatric age group. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia including that associated with accessory bypass tracts (wolf Parkinsonwhite syndrome) when clinically advisable appropriate vagal 3/Mar/97 6/Mar/97 3/Apr/97 14/May/9 7 21/Aug/9 6 10/Apr/97 2/Sep/96 15/Apr/97 30/Apr/97 5/May/97 6/Jun/97 8/Jul/97 116. 117. Azelastine Nasal spray 0.01gm per 10ml Stavudine caps 15MG/20MG/30MG/40MG manoeuvres should be attempted prior to adenosine administration. Allergic rhinitis and perennial 15/Jul/97 rhinitis. In adult patients with advanced 12/Jul/97 HIV infection who are intolerant of approved therapies. Skin diseases where treatment 6/Aug/97 with topical corticosteroid is appropriate. 118. Prednicarbate Cream [Each gm of cream contains, Prednicarbate-2.5mg] 119. For B.P.H. 12/Sep/9 7 120. Serenoa-Repens cap[Each soft gelatin caps contains 160mg lipid extract to serenoa repons] Calcium Dobesilate caps -500mg Chronic venous insufficiency of lower limbs only 22/Sep/9 7 121. Alendronate Sodium tab -10mg Post-menopausal osteoporosis only. 18/Sep/9 7 122. Cefpodoxime Proxetil tab/syrup [Each tab contains, Cefpodoxime Froxetil100mg, Each 5ml suspension contains Cefpodoxime Proxetil-40mg] 19/Sep/9 7 123. Cefpirome injection 0.25g/0.5g/1.0g/2gm per vial 124. Idebenone tablets -30mg 125. Doramectin 1% injection solution (vet) 126. Bifonazole cream/solution/powder [1gm of cream/powder contains Bifonazole-0.01gm and 1ml of solution contains Bifanazole-0.01gm] Sodium Picosulphate Tab/Syrup [1. Each uncoated tab contains, Sodium Picosulphate-5mg/10mg 2. Each 5ml syrup contains, Sodium Picosulphate5mg] Tiaprost Trometamol inj (vet) 150mg Acute bronchitis, exacerbations of chronic bronchitis, bronchiolitis pneumonia, sinusitis, recurrent chronic tonsillitis, pharyngitis, acute otitis. Infections caused by cefpirome sensitive organism, lower respiratory tract infection, complicated upper and lower urinary tract infections, bacteraemia, and septicaemia. In the treatment or improvement of decreased volition emotional disturbances and speech disturbances associated with sequelae of cerebral infraction, sequelae of cerebral haemorrhage, cerebral arteriosclerosis. Treatment and control of gastrointestinal roundworms, Lungworms, eye worms, screw worms in cattle. Skin mycosis caused by dermatophytes, yeast moulds, other fungi. Constipation bowel clearance before labour or surgery, radiological examination. 11/Feb/9 7 In inducing pasturition in cows 19/Feb/9 127. 128. 26/Sep/9 7 26/Sep/9 7 17/Oct/97 28-11-97 129. Teicoplanin For IM/IV Injection 100mg/200mg/400mg per vial 130. Clobazam tablets 5mg/10mg/20mg 131. Leuprolide acetate depot injection 3.75mg per vial Saccharomyces boulardii (caps/sachets)[Each capsule/sachets contains Saecharomyces boulardii 282.5mg] Isepamicin injection 100mg/250mg per vial 132. 133. 134. Fluconazole 0.3% w/v 135. Clotrimazole soft gel pessary 100MG 136. Tolfenamic acid caps 200mg 137. Melatonin tab -3mg 138. Biphenyl acetic acid gel -3.00%w/w 139. 140. Irinotecan HCl trihydrate solution for IV infusion 20 mg /ml in 2 ml & 5 ml packsize Lamotrigine tab -25mg 141. Propofol injection 10mg per ml 142. Ciprofibrate tabs -100mg and buffalos use in serious gram +ve infection staphylococcal infection in patients sensitive or unresponsive to penicillin’s and cephalosporin’s CAPD related peritonitis, prophylaxis in orthopaedic surgery at risk of gram +ve infection. Acute and chronic anxiety states and as an adjunctive therapy in patients with refractory epilepsy. Indicated for the treatment of prostatic cancer only. For irritable bowel syndrome, antibiotic associated diarrhea, diarrhea due to enteral feeding in adults only. Lower respiratory tract infection, intra-abdominal infection, urinary tract infection, skin and soft tissue infection and septicemia. For fungal corneal ulcers/keratitis only Vaginal candidiasis Rheumatoid arthritis, osteo arthritis, ankylosing spondylitis and related conditions associated with pain. For sleep disorder, jet lag, and regulation of circadian rhythm disorder For the relief of symptoms of soft tissue injuries, extra articular rheumatic or inflammatory conditions, acute inflammatory manifestations of osteo arthritis or knee joint pain and swelling following injury. For the treatment of colo-rectal cancer Add on therapy for partial and secondary generalized tonicclonic seizures in adults not below 16 years of age. Induction and Maintenance of general anesthesia. Indicated in treatment of primary hyper lipidaemia resistant to appropriate dietary management including cholesterolaemia, hyper 7 19/Feb/9 7 11/Nov/9 7 10/Dec/9 7 18/Dec/9 7 26/Dec/9 7 4/Feb/98 17/Feb/9 8 4/Mar/98 12/Mar/9 8 27/Apr/98 22/May/9 7 14/May/9 8 18/May/9 8 1/May/98 143. Sertraline tab 50mg/100mg 144. 145. 146. Sertraline tab 25mg Losartan Potassium tablets 25mg/50mg/100mg Ritonavir 100mg 147. Alprazolam SR tab 1.5mg 148. 149. Lomefloxacin eye drops 3mg/ml Rivastigmine capsules 0.5mg/1.0mg/1.5mg/3mg/4mg/5mg/6 mg Oxybutynin chloride Tab/Syrup [ 1. Each uncoated tab contains Oxybutynin chloride-2.5mg/5mg 2. Each 5ml syrup contains Oxybutynin chloride-2.5mg] 150. 151. Fexofenadine Hcl tablet 120mg/180mg 152. Simvastatin tab 5mg/10mg/20mg/40mg 153. 154. Carvedilol 12.5/25mg tablet Pantoprazole sod. Tab 20 / 40mg 155. Zidovudine (300mg) tabs 156. Oxaliplatin Freeze dried powder for IV injection 50mg/100mg per vial Vindesine Sulphate Injection 1mg/5mg per vial 157. triglyceriaemia and hyper lipidaemia (Fredrickeson types IIa, IIb, III and IV) Major depressive disorders obsessive compulsive disorders (OCD), panic disorder For panic disorder only. mild to moderate hypertension only. in the treatment of advanced HIV infection by qualified physician not below the age of 12 years to be administered. Short term symptomatic treatment of anxiety including anxious patients with symptoms of depression Bacterial infection of the eye treatment of patients with mild to moderate dementia of Alzheimer type For urinary incontinence, urgency and frequency in the unstable bladder whether due to neurogenic bladder disorders or to idiopathic detrusor instability and nocturnal enuresis. In the treatment of relief of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria in adults only. Primary hypercholesterolemia, type IIa and type IIb alone or in association with CAD. Essential hypertension only For the treatment of gastric ulcer, duodenal ulcer, moderate and severe reflux oesophagitis. For HIV For treatment of advanced colorectal cancer. Acute lymphocytic leukaemia of childhood resistant to vincristine sulphate, non -Hodgkin’s lymphomas, malignant melanoma, non-small cell carcinoma of the lung, blast crisis of chronic granulocytic leukaemia and carcinoma of the breast. 9/Jun/98 9/Jun/98 16/Jun/98 8/Sep/97 22/Jul/98 31/Jul/98 3/Sep/98 16/Sep/9 8 25/Sep/9 7 16/Oct/98 9/Dec/98 18/Dec/9 8 26/Oct/98 28/Oct/98 Note: It may be stated that the above list of New Drugs is prepared as per the records available with the office of DCG (I). In case any inconsistency is observed, same may be brought to the notice of DCG (I) for necessary action.
