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LIST OF NEW DRUGS APPROVED IN INDIA FROM 1971 TO 1980

S.No Name of Drug Pharmacological action/ Date of Indication Approval 1 2-Thymyl-oxy-methyl January-1971 glyoxalidine Hydrochloride 0.05 + Buffered Aqueous Vehicle- q.s (Nasal Spray) 2 Hamycin Glycerine (300,000 January-1971 Units/ml) Suspension 3 Ferrous Sulphate 150mg January-1971 Sustained Release 4 Hydroxyurea USP 500mg Anti neoplastic agent. January-1971 Capsule 5 Prednisolone Stearoylglucolate February-1971 (6.65mg) Tablet, (1.9g) Ophthalmic Ointment, (1.9g) Cream & Ointment 6 Hydroflumethiazide 25mg March-1971 Tablet 7 Chlorphenoxamine Hcl 12mg March-1971 Tablet 8 Epsilon Caproic Acid March-1971 250mg/ml Injection 9 Ibuprofen 200mg Tablet Anti rheumatic. March-1971 10 Mebeverine Hcl 50mg Tablet Musculo tropic spasmolytic. March-1971 11 Panchronium Bromide 4mg/ml Muscular relaxanting agent. April-1971 Injection (i.v) 12 Sulphide 75mg May-1971 Sustained Release Capsule. 13 L-Dihydroxyphenylalanine May-1971 500mg Capsule/Tablet 14 Rifampicin 450mg Anti T.B drug June-1971 15 25mcg Tablet Oestrogenic . July-1971 16 Ketamine Hydrochloride Anaesthetic agent. August-1971 17 Ibuprofen 200 mg Tablet September-1971 18 Rifampicin 150mg/300mg September-1971 Capsule 19 Glybenclamide 5mg Tablet September-1971 20 Mebeverine Hcl 100mg Tablet Musculo tropic spasmolytic. October-1971 21 P-Aminomethyl Benzoic Acid October-1971 50mg/5ml Ampoule 22 Lactobacillus Sporogenes October-1971 50/100million Tablet 23 Sulphate B.P Bronchial asthma. October-1971 24 Yeast Tannic Acid Compound Anti-diarrhoeal agent. October-1971 25 Cephalexin Broad spectrum . October-1971 26 Pheniramine Maleate Retard November-1971 Tablet 27 Propranalol Hcl 10mg Tablet November-1971 & (1ml) Injection 28 Tetranicotinoyl Fructose November-1971 29 Testolactone November-1971 30 Spiramycin Injection November-1971 31 Tetranicotinoyl Fructose December-1971 250mg Tablet 32 Prednisolone IP 10 mg Retard December-1971 Tablet 33 Clopidol (For Veterinary) Coccodiosis. January-1972 34 3,5 - Dinitro-O-Toluamide (For January-1972 Veterinary) 35 Fenfluramine Hcl Anti-obesity drug. January-1972 36 Testolactone 50mg Tablet March-1972 37 Fenfluramine Hcl 20mg Tablet April-1972 38 Marek's Disease Vaccine April-1972 T.H.U Living (For Veterinary) 39 Ferric Sodium Citrate April-1972 40 Prothionamide 125mg Tablet June-1972 41 Prothionamide B.P. Anti T.B. June-1972 42 Sarcolysin I.P. Anti cancer. June-1972 43 Pyrantel Pamoate USP Anthelmintic. July-1972 44 Hydrochloride Psychotic drug. July-1972 45 Biperiden Hydrochloride Parkinsonism. July-1972 46 Marcaine 0.25% with & September-1972 without and Marcaine 0.5% with or without adrenaline 47 Doxepine Hydrochloride September-1972 10mg/25mg/50mg Tablet/Dragee/Capsule 48 Bupivacaine Hydrochloride Anaesthetic. September-1972 49 Decanoate Anti-psychotic. September-1972 50 2-Bromo-2-Nitropropan-1,3- Preservative. September-1972 diol 51 Hcl (10mg/40mg) October-1972 Tablet & (1mg/ml) Injection 52 Chloramphenicol 500mg October-1972 Capsule 53 Biperiden Lactate 5mg/ml Parkinsonism. October-1972 Ampoule 54 Cyclandelate Vasodilating agent. October-1972 55 Theophylline Ethanoate of November-1972 (0.25gm) Tablet & (0.125gm/ml) Syrup 56 i)Betadine Solution containing November-1972 10% of Povidone Iodine, ii)Betadine Gargle containing 0.5% of Povidone Iodine, iii)Betadine Ointment containing 10% of Povidone Iodine. 57 Ferrous Sulphate 160mg Slow November-1972 Release Tablet 58 Lithium Carbonate 250mg November-1972 Capsule 59 Oxyclozanide (For Veterinary) November-1972 60 Sodium Cromoglucolate Anti-asthmatic drug. November-1972 61 Fenfluramine Hcl 20mg Tablet December-1972 62 Doxycycline Hcl (eq. to December-1972 Doxycycline base) 100mg Capsule 63 Isopropyl Thioimidazolidine December-1972 5mg Tablet 64 Lincomycin Hydrochloride December-1972 500mg Capsule 65 Mitomycin-C 2mg/Vial December-1972 66 Amantadine Hydrochloride Parkinsonism. December-1972 67 Daunorubicin Anticancer. December-1972 68 Hcl 4mg January-1973 Tablet 69 Cyclandelate 200mg Tablet February-1973 70 Xantinol Nicotinate 500mg February-1973 Sustained Release Tablet 71 Ethacrynic Acid USP Non-thiazide saluretic diuretic. February-1973 25mg/50mg Tablet 72 Salbutamal Sulphate 4mg February-1973 Tablet 73 Beclomethasone Dipropionate Topical corticosteroid. February-1973 B.P. 74 Parbendazole (For Veterinary) Treatment of Helmenthiasis. February-1973 75 Ethacridine Lactate Anti-diarrhoeal agent. February-1973 76 2mg Tablet March-1973 77 Oxyfedrine Coronary vasodilator. April-1973 78 Trifluperidol Hcl 5mg/5ml Neuroleptic agent. May-1973 Oral Liquid 79 Trifluperidol Hcl 1mg/ml Neuroleptic agent. May-1973 Injection 80 Trifluperidol Hcl Neuroleptic agent. May-1973 0.25mg/0.5mg Tablet 81 Polyglycolic Acid Sutures May-1973 82 L-Asparaginase Anticancer. May-1973 83 Lincomycin Hcl (eq. to June-1973 Lincomycin base) 250mg/5ml Syrup 84 Lactate 60mg June-1973 Tablet 85 Hydrochloride Beta-blocker. June-1973 86 Furaltadone June-1973 87 Nitrazepam Epileptic. June-1973 88 Tetramisole Hydrochloride July-1973 30% (For Veterinary) 89 Oxyfedrine (8mg) Tablet, Coronary Vasodilator- for July-1973 (10mg) Solution, (2mg/ml) pectoris, Myocardial Injection infarction and Coronary insufficiency. 90 Furaltadone 20% w/w Powder Poultry diseases only. August-1973 (For Veterinary) 91 Alphachymotrypsin 5mg/vial For use of eye specialists only. August-1973 Injection 92 Carbenicillin Disodium Antibiotic. August-1973 1gm/vial Injection 93 Pentazocine base (as August-1973 Hydrochloride) 50mg Tablet 94 Marantel Tartrate August-1973 95 Nitrazepam 5mg Tablet September-1973 96 Fluphenazine Decanoate September-1973 2mg/ml Injection 97 Hydrochloride September-1973 25mg/2ml Injection 98 Lorazepam Psychiatric drug. September-1973 99 Tablet Beta blocking agent September-1973 100 Nitroxazepine Hydrochloride October-1973 25mg Tablet 101 Pindolol 5mg Tablet November-1973 102 Aprotinin Acute Pancreatitis. November-1973 103 Cardiac Drug. November-1973 104 Malathion 1% Dusting Powder December-1973 105 Lorazepam 1mg/2mg Tablet Psychiatric drug. December-1973 106 Bleomycin Anticancer. December-1973 107 Carbenoxolone Sodium Gastric ulcer. December-1973 108 Betamethasone-17-Benzoate Topical anti-inflammatory December-1973 steroid. 109 Thiophanate (For Veterinary) Anthelmintic. December-1973 110 Practolol BP 100mg Tablet January-1974 111 Aprotinin 100,000 KIU/5ml & January-1974 200,000 KIU/10ml Injection 112 Carbenoxolone Sodium 50mg January-1974 Tablet 113 Meglumine iocarmate X-ray contrast media. February-1974 114 Clomiphene Citrate B.P 50mg Fertility drug- induction of February-1974 Tablet ovulation in patients with persistant ovulatory dysfunction who desire pregnancy. 115 150mg Tablet Trichomonial agent- for the February-1974 treatment of trichomoniasis & intestinal . 116 Nitrofurantoin BP March-1974 100mcg/200mcg Sensitive Disc 117 Beclomethasone Dipropionate April-1974 0.025% Cream & Ointment 118 d- 0.03mg Coated Oral contraceptive. April-1974 Tablet 119 Epicillin (6-aminopenicillanic Antibiotic- For the treatment as May-1974 acid) 250mg/500mg Capsule respiratory tract, G.I. Tract and genitourinary tract . 120 Sodium Fusidate 20mg/gm Antibiotic- for the treatment of May-1974 Ointment staphylococcal infections such as abscesses boils, carbuncles, varicose ulcer,eczema. 121 Tretinoin 0.05%/20gm Topical acne therapy- For the July-1974 Vanishing Cream treatment of Acne vulgaris. 122 Tretinoin 0.05%/50ml Lotion July-1974 123 Tretinion 0.05% Swab July-1974 124 Tretinion 0.05% Cream July-1974 125 10mg Tablet Oral androgen- In the treatment July-1974 of potency disturbances, infertility and hypogonadism only. 126 D-Pencillamine 300mg Tablet Metalic poisoning- In the July-1974 treatment of metalic poisoning and Wilson's disease. 127 d-Norgestrel 0.03mg Tablet August-1974 128 Pimozide Neuroleptic and anti psychotic August-1974 agent- In the treatment of chronic Schizophrenia. 129 Lidoflazine 60mg Tablet Coronary Vasodilator- November-1974 Indicated in the treatment as Ischaemic heart disease and prophylaxis after treatment of myocardial infarction. 130 Isoptin Hydrochloride September-1974 5mg/2ml Injection 131 Oxolinic acid Urinary antibacterial- For the September-1974 treatment of acute & chronic urinary tract infections. 132 Salbutamol Sulphate 2mg/5ml October-1974 Elixir 133 Bupivacaine hydrochloride December-1974 10mg/ml Hyperbaric Solution 134 Pimozide 1mg/4mg Tablet December-1974 135 Mebendazole 100mg Tablet Broad spectrum anthelmentic- December-1974 For the treatment of enterobiasis as carriasis, trichuriasis ancyclostomiasis, strongylodiasis (pin warm, large round warm, whip warm, hooks warm and thread warm. 136 Miconazole 2% Cream Topical antifungal and anti December-1974 bacterial agent- for the treatment of onychomycosis, dermatophytosis and vulvovaginitis. 137 Desamino-oxytocin Indicated in the treatment of December-1974 induction of labour for various reasons for adequate uterine action. 138 Virginiamycin obtained from Antibiotic- Indicated for February-1975 streptomyces virginiae growth propotion in poultry (Veterinary) pigs and for prevention & treatment of swine dysentry. 139 Extract of Centella Asiatica Indicated in the treatment as February-1975 ulcers, burns, skin grafts, keloids, bed sore etc. 140 Hcl Antihypertensive agent- February-1975 indicated in the treatment of hypertension. 141 Niflumic acid Anti-inflammatory drug - February-1975 Indicate in the treatment of rheumatoid arthritis, osteoarthritis. 142 Testolactone 10mg/mL March-1975 Injection 143 Nitroglycerine 2.6mg March-1975 Sustained Release Tablet 144 B.P 0.5mg Tablet March-1975 145 Doxorubicin Hydrochloride Anticancer drug- indicated in April-1975 10mg/vial the treatment of various types of neoplasia, both acute & chronic leukaemia lymphomata, soft tissue sarcomata, breast and lung cancer. 146 Betahistine dihydrochloride Indicated in the treatment as April-1975 Meniere's syndrome characterised by unilatered or bilatered tinnitus, vertigo usually accompanied by sensory neural hearing loss. 147 dl-norgestrel 0.5mg + Ethinyl Oral contraceptive. April-1975 oestradiol 0.03mg 148 2-Bromo-2-nitropropan-3-diol April-1975 149 Niflumic Acid 250mg Capsule April-1975 150 Clotrimazole Antifungal & local anti May-1975 trichomonial agent- Indicated against certain bacteria, protozoa and against certain organism which are sensitive to . 151 Clotrimazole 0.1gm Vaginal June-1975 Tablet 152 Clotrimazole 1gm/100gm June-1975 Cream 153 Clotrimazole 1gm/100ml June-1975 Cream Solution 154 Desoximetasone Topical corticosteroid- July-1975 Indicated in the management of various acute and chronic dermatoses viz eczema, nummular eczema, infantile eczema, atopical dermatitis. 155 Carbadox (For Veterinary Use) Antibiotic- indicated in the July-1975 treatment of swine dysentry and bacterial enteritis. 156 Alphachymotrypsin- 25chg July-1975 Units Tablet 157 2% premix contains; 40gm of July-1975 Virginiamycin, 50% granules per kg (For Veterinary) 158 Clonidin Hcl 100mcg July-1975 Tablet/Capsule 159 Clonidine Hcl 0.15mg Tablet July-1975 160 Dimetridazole (For Veterinary Growth promotant in poultry. August-1975 Use) 161 Sodium Fluoride B.P. 20mg August-1975 Enteric Coated Tablet 162 Urea (30%) 300mg/ml August-1975 Solution for Intra Amniotic Use 163 Miconazole Nitrate 20mg/gm August-1975 Powder 164 Pentoxifylline Vasodialator- indicated in the September-1975 treatment of arterial and arteriovenous circulatory disorders. 165 Desoximetasone 2.5mg/gm September-1975 Ointment 166 Malathion 0.5% Lotion For treatment of pediculosis September-1975 only. 167 Sodium Chloride 20% October-1975 Hypertonic saline for intra- amniotic use 168 Trofosfamide indicated in the treatment of November-1975 lymphogranulomatosis, lymphosarcoma, reticulosarcoma,ovarian carcinoma, carcinoma of breast. 169 Pentoxifylline 100mg Dragee November-1975 170 Pentoxifylline 100mg/5ml November-1975 Ampoule 171 Beclomethasone Dipropionate December-1975 50mcg MDI 172 Cephradine Antibiotic- indicated in the January-1976 treatment of of G.I., genito-utrinary, respiratory tract and soft tissue. 173 Mefanamic Acid Analgesic with Anti January-1976 inflammatory properties- indicated in the treatment of acute & chronic pain post operative and postpartum pain, headaches, traumatic pain, muscular pain. 174 Catalin Anti-cataract Preparation- January-1976 indicated in the treatment of cataract. 175 Glydiazinamide Oral hypoglycemic acid- February-1976 indicated in the treatment of diabetes. 176 Cephradine 250mg/500mg March-1976 Capsule 177 Each vial contains; Cephradine March-1976 250mg, 500mg &1gm 178 Cephradine 250mg/5ml March-1976 Suspension 179 Metronidazole Benzoate (eq. to April-1976 of Metronidazole) 125mg/5ml Suspenion 180 Sodium Cromoglycate (Bulk) May-1976 181 Extract of Centella Asiatica 2% May-1976 / Vial 182 Extract of Centella Asiatica May-1976 200mg Tablet 183 Extract of Centella Asiatica 1% May-1976 Ointment 184 Extract of Centella Asiatica 2% May-1976 Powder 185 Oxibendazole 1.33% w/w Veterinary anthelmentic- May-1976 Premix (For Veterinary) indicated in the treatment of gastro-intestinal nematodes, infections of cattle, sheep, horses and other domestic animals. 186 Clonidine Hcl 150mcg/ml June-1976 Injection 187 Ammosidine Sulphate Antibiotic- indicated in the June-1976 500mg/Vial treatment of staphylococcus sepsis, infection of the respiratory tract due to staphylococcus and pneumococcus, infections of the urinary tract due to E.coli, P.vulgaris, Gonococci infection resistant to other . 188 Dexchlorpheniramine Maleate July-1976 2mg Tablet 189 Halcinonide Topical cream- indicated in the July-1976 treatment of various common dermatosis. 190 Trofosfamide 50mg Tablet August-1976 191 Metronidazole Benzoate (eq. to August-1976 Metronidazole) 200mg/5ml Suspension 192 Doxorubicin Hcl 10mg/Vial September-1976 193 Disodium Cromoglycate 2% September-1976 Nasal Drops 194 Valethamate Bromide November-1976 195 Asiaticoside November-1976 196 Metoclopromide December-1976 Monohydrochloride 10mg Tablet 197 Metoclopromide Anti-emetic. December-1976 Monohydrochloride 10mg/2ml Injection 198 Tetramisole Hcl 50mg/5ml December-1976 Syrup 199 Loperamide Anti diarrhoeal agent- December-1976 indicated in the treatment of acute diarrhoea due to food poisoning, viral infections. 200 Fusafungine Fungal antibiotic- indicated in January-1977 the treatment of sinusitis, pharyngitis, sore throat, laryngitis bronchitis, prevention of respitratory complication. 201 Flupenthixol Neuroleptic agent- indicated in January-1977 psychotic and schozophrenic cases where sedative and hypnotics effects are contra- indicated. 202 Isometamidium Chloride (For Indicated in treatment of January-1977 Veterinary) cardiac arrhythmias including atrial fibrillation, ventricular tachycardia, arrhythmia. 203 Elemental Iron in a complex February-1977 of Iron Polymaltose 50mg/ml Drops 204 Flupenthixol Hydrochloride February-1977 0.5mg Tablet 205 Fusafungine Hcl 25mg Aerosol March-1977 206 Loxitalmic Acid For cerebral angiography and April-1977 urography (X-ray contrast media) 207 B.P 0.35mg May-1977 Tablet 208 Bromelin 50mg + Pancratin Indicated for Pancreatic May-1977 400mg + Ox bile 30mg insufficiency. (Enzyme) 209 Dothiepin Hydrochloride Anti depressant- indicated in May-1977 the treatment of psychotic depression, neurotic depression, anxiety, depression. 210 Disopyramide 100mg Capsule June-1977 211 1-(2-tetrahydrofuryl)-5- Anticancer drug- indicated in June-1977 Fluorouracil the treatment of cancer of stomach, colon, rectum, breast and lung. 212 Flupenthixol Decanoate July-1977 20mg/ml Injection 213 Cyclandelate 200mg Capsule July-1977 214 Pentoxyfyline Bulk August-1977 215 Meglumine & Sodium salt of September-1977 loxitalanic acid 62.5% 216 Sulfinpyrazone Bulk September-1977 217 Sulphinpyrazone 100mg Tablet September-1977 218 Sulphinpyrazone 200mg September-1977 Capsule 219 Doxapram Hydrochloride Respiratory stimulant- for the September-1977 treatment of post-operative respiratory depression and respiratory depression due to poisoning. 220 Suramin Injection (For September-1977 Veterinary) 221 Nimorazole 250mg Tablet For trichomoniasis. October-1977 222 Pentazocine Lactate 30mg/ml October-1977 Injection 223 Anti-Tetanus activity 500IU + October-1977 Anti-Diptheria activity 1000IU Immunoglobulin (Human) Injection 224 Ethacridine Lactate 1mg/ml October-1977 Injection 225 5-Fluorourail 250mg Capsule November-1977 226 Orphenedrine Citrate November-1977 60mg/2ml Ampoule 227 Betamethasone Sodium November-1977 Phosphate 1mg + Gentamicin Sulphate (eq. to Gentamicin) 1mg (Eye Drops & Ointment) 228 Diazepam 5mg/ml Injection December-1977 229 Fluprednylidene-21-Acetate Topical corticosteroid- December-1977 Indicated in the treatment of allergic inflammmatory dermatoses. 230 Beta-Methyl Digoxin Cardiac glycoside. December-1977 231 2-Pyrrolidone Acetamide Indicated in treatment for December-1977 behaviour and psychotic

problems in old age and mental retardation in children 232 Fluprednylidene-21-Acetate January-1978 0.1mg/100gm Cream 233 2-Pyrrolidone acetamide- January-1978 400mg Capsule 234 2-Pyrrolidone acetamide- January-1978 200mg/2ml Injection 235 Gentamicin sulphate (eq to January-1978 Gentamicin base) 2mg/ml Injection 236 Betamethyl Digoxin 0.1mg & March-1978 0.5mg Tablet 237 Betamethyl Digoxin 0.6mg March-1978 Liquid 238 Betamethyl Digoxin 0.1mg March-1978 Injection 239 Diethylamine Salicylate 10% March-1978 w/w Cream 240 Methylprednisolone Corticosteroids- Indicated for March-1978 conditions requiring glucocorticoid activity including collagen disease, allergic disease, hypersensitivity reactions. 241 N-Phenylethyl Anthranilic April-1978 Acid 300mg Capsule 242 Chlorpheniramne Maleate USP April-1978 8mg Sustained Release Tablet 243 Miconazole Nitrate 100mg June-1977 Vaginal Pessary 244 Protein derived from Soya June-1977 Bean 33.2gm/150gm 245 Sulfametopyrazine The drug sulphametopyrazine June-1978 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. 246 extracted from Haemorrhoids- Indicated in the June-1978 Rutacea (Aurantiaceae) treatment of haemorrhoids. containing a standard amount of Diosmin 247 Salcatonin Synthetic Salmon calcitonin- July-1978 polypeptide hormone. 248 Dicloxacillin Antibiotic- infection of July-1978 respiratory tract, skin and mucosa infection, bone infection. 249 Betamethasone Benzoate August-1978 250 Beta-blocker- indicated in the August-1978 treatment of angina pectoris, hypertension, cardiac arrythmias. 251 Diazoxide Antihyertensive agent- August-1978 indicated for reduction of blood pressure in malignant hypertension. 252 Sulphate IP 200mg September-1978 Capsule 253 Human Placental Extract September-1978 Injection 254 Povidone Iodine USP 4% September-1978 Scrub 255 Povidone Iodine USP 5% September-1978 Solution 256 Povidone Iodine USP 5% September-1978 Ointment 257 Allergens September-1978 258 Ifosfamide Anticancer- indicated in the September-1978 treatment of ovarian, breast, testicular carcinoma, hyper nephrone, pancreatic carcinoma and malignant lymphoma. 259 Loperamide Bulk October-1978 260 Lymecycline (eq. To October-1978 Tetracycline) 300mg Capsule 261 Amitryptylline Hydrochloride October-1978 25mg Tablet 262 Hydrochloride October-1978 0.25% (Paediatric) 263 Bleomycin 5mg Injection October-1978 264 Glucagon Injection Hypoglycemic agent- indicated October-1978 in the treatment of severe hypoglycemic reaction in diabetic patients. 265 Human Follicle Stimulating Fertility drug- to be supplied to October-1978 Hormone (FSH) and Human gynaecologists attached to Leutenising Hormone (LH) hospitals where facilities exist Injection for screening patients and to private consultations of academic & professional standing. 266 Metronidazole IP 2mg/ml I.V November-1978 Injection 267 Indapamide Hemihydrate Antihypertensive- for mild to November-1978 2.5mg Tablet moderate hypertension. 268 Choline Salicylate 8.7% November-1978 Solution 269 Doxapram Hydrochloride November-1978 20mg/Vial 270 Mebendazole 100mg/5ml December-1978 Suspension 271 Trichlormethiazide USNF 2mg Diuretic- in the treatment of December-1978 Tablet hepatic cirrohsis, edema, hypertension. 272 Benorylate 250mg Tablet Analgesic & antipyretic- December-1978 treatment of headache, bodyache, fever, rhinitis, sinutitis. 273 Benorylate 2gm/5ml Analgesic & antipyretic- December-1978 Suspension treatment of headache, bodyache, fever, rhinitis, sinutitis. 274 Amoxycillin Antibiotic- indicated in the December-1978 treatment of urinary tract infections, respiratory, genito- urinary, ENT and soft tissue infections. 275 Sodium Salt + Methyl Contrast media. December-1978 Glucamine Salt of Diatrizoate (40:18) Injection 276 Galanthamine Hydrobromide Treatment of neuritis & December-1978 Tablet & Injection poliomyelitis, infantile cerebral palsies. 277 Amoxycillin 250mg/500mg January-1979 Capsule 278 Amoxycillin 125mg/5ml & January-1979 250mg/5ml Syrup 279 Amoxycillin 125mg/1.25ml January-1979 Paediatric Suspension 280 Naproxen 250mg Tablet Steroidal anti-inflammatory January-1979 agent indicated in the treatment of rheumatoid arthritis. 281 Salbutamol Sulphate January-1979 50mg/5ml Injection 282 5-Fluorouracil 250mg/5ml Oral January-1979 Solution 283 Pamoate indicated in the January-1979 75mg/150mg Capsule treatment of all form of depression. 284 Allergen Extracts January-1979 285 Fenbendazole Anthelmetic- indicated to treat January-1979 gastro-intestinal nematodes infections of live stocks. 286 Carboprost Tromethamine Abortificient- for the treatment March-1979 250mcg/ml Sterile Solution of second trimester abortions only. 287 Chlorphenoxamine Embonate March-1979 17.5mg/5ml Syrup 288 Ifosfamide 200mg/500mg/1gm March-1979 per Vial 289 Miconazole Nitrate 2% March-1979 Solution 290 Ibuprofen 100mg/5ml April-1979 Suspension 291 Oxyfedrine 24mg Tablet April-1979 292 Hydrochloride April-1979 40mg Sustained Release Tablet 293 Clemastine Anti-histaminic- indicated in April-1979 the treatment of all allergic rhinitis, urticaria, pruritus, itching, dermatoses. 294 Niflumic Acid 250mg Capsule May-1979 295 Imipramine Pamoate May-1979 75mg/150mg Capsule 296 Amoxycillin June-1979 250mg/500mg/1gm per Vial Injection 297 Synthetic Diosmin 150mg Haemorhoids- indicated in the June-1979 Tablet & Capsule treatment of haemorrhoids. 298 Sodium Nitroprusside USP July-1979 50mg/Vial Injection 299 Desoximetasone 0.05% July-1979 Ointment 300 Flurbiprofen 50mg/100mg Non steroid anti inflammatory- July-1979 Tablet Indicated in the treatment of rheumaoid arthritis, Oesteoarthritis and allied disorders. 301 Clopamide 20mg Tablet Diuretic- indicated in the July-1979 treatment of oedema of cardiac hepatic or renal origin and hypertension only. 302 Epicillin 250mg/500mg August-1979 Capsule 303 Epicillin 250mg & 500mg August-1979 Injection 304 Epicillin 125mg/5ml & August-1979 250mg/5ml Oral Suspension 305 Tetracycline Hcl 250mg August-1979 Sustained Release Capsule 306 Dicloxocillin Sodium August-1979 125mg/250mg Capsule 307 Dioctyl Sodium Sulfosuccinate September-1979 USP Ear Drops5% 308 Silver Sulphadiazine 1%w/w Antibacterial agent- indicated September-1979 Cream in the treatment of burn & wound infections. 309 Bromhexine Hydrochloride Mucolytic agent- indicated in September-1979 8mg Tablet the treatment of brochitis and other conditions where sputum is troublesome. 310 Bromhexine Hcl 4mg/5ml Mucolytic agent- indicated in September-1979 Elixir the treatment of brochitis and other conditions where sputum is troublesome. 311 Dicloxocillin Sodium 62.5mg September-1979 Oral Solution 312 Natamycin 2% Cream Trichonomial agent- indicated September-1979 in the treatment of vaginal irritation & discharge due to monilial, trichomonial infections. 313 Betamethasone Dipropionate Topical corticosteroid- October-1979 0.5mg/g Ointment Indicated in the treatment of psoriosis, contact dermatitis, atopic dermatitis neurodermatitis, senile pruritus. 314 Albendazole 2.5% w/v & 10% Anthelmetic- indicated in the October-1979 w/v Suspension control of Gastro-intestinal roundworm, lungworm, tapewarm & adult liver flukes in cattle, sheep. 315 Natamycin 25mg Vaginal October-1979 Tablet 316 Dihydrochloride 50mg Cardiac drug- indicated in the November-1979 Tablet treatment of coronary insufficiency, coronary sclerosis, angina pectoris as well as for prophylaxis and follow up treatment of myocardial infarction. 317 Sulphate Anti-asthmatic drug- indicated November-1979 2.5mg/5mg Tablet in the treatment of asthma. 318 Terbutaline Sulphate 0.3mg/ml Anti-asthmatic drug- indicated November-1979 Syrup in the treatment of asthma. 319 Glycopyrrolate 0.2mg/ml Anaesthetic agent- for use as a December-1979 Injection pre operative antimuscarine to reduce salivary, tracheobronchial & phyrigeal secretions, arrhythmias & brodycardia associated with reversal o muscle relaxant. 320 Hydrochloride Sympathomemetic agent- January-1980 200mg/5ml Injection Indicated for the correction of haemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma endotoxic septicenia, open heart surgery, renal failure. 321 Succinate 2mg Tablet Estrogen- indicated in the March-1980 treatment of local and general complaints arising from diminished estrogen production after the menopause and after surgical removal of ovary. 322 Amoxycillin Trihydrate 125mg March-1980 Dispersible Tablet 323 Salbutamol Sulphate B.P 8mg March-1980 Sustained Release Tablet 324 Tylosin Tartrate (For Antimicrobial- Aid in the May-1980 Veterinary) treatment of chronic respiratory disease in chicken and for maintaining weight gain and feed efficiency in Turkey. 325 100mg/ml Injection Anti-ulcer, indicated for May-1980 treatment of benign gastric, duodenal, recurrent and stomal ulceration, reflex oesophagitis only. 326 Cimetidine 200mg Anti-ulcer, indicated for June-1980 Tablet/Capsule treatment of benign gastric, duodenal, recurrent and stomal ulceration, reflex oesophagitis only. 327 Cimetidine 200mg/5ml Syrup Anti-ulcer, indicated for June-1980 treatment of benign gastric, duodenal, recurrent and stomal ulceration, reflex oesophagitis only. 328 Trimetazidine Dihydrochloride Cardiac drug- indicated in the June-1980 3mg Tablet treatment of angina pectoris and intermittant Claudication. 329 Citrate Breast cancer in pre & post June-1980 menopausal women. 330 Cytarabine Injection Anticancer indicated in the June-1980 treatment of acute myeloid leukaemia. 331 Xipamide 40mg Tablet Diuretic- indicated in the July-1980 treatment of oedema and hypertension only. 332 Levamisole Hydrochloride July-1980 15% w/w & 30% w/v Mixture 333 Levamisole 18.2% w/v July-1980 Injection 334 Medrysone USP 1% July-1980 Ophthalmic Suspension 335 Trypsin + Chymotrypsin July-1980 10,000 Armour Units per ml Ointment 336 Terbutaline Sulphate 0.5mg/ml July-1980 Injection 337 Halofuginone (For Veterinary) Poultry feed additive- for July-1980 prvention & treatment of poultry Coccidiosis. 338 Methicillin Sodium Antibiotic- indicate in the July-1980 treatment of infections due to pencillinase producing staphylococa. 339 Quinapyramine August-1980 Sulphate/Chloride (Bulk) 340 Bumetidine 1mg Tablet Diuretic- indicated in the August-1980 treatment of oedema associated with congestive heart failure, coronary oedema, hepatic ascites and renal disease including nephrotic syndrome. 341 Bumetidine 0.25mg/ml Diuretic- indicated in the August-1980 Injection treatment of oedema associated with congestive heart failure, coronary oedema, hepatic ascites and renal disease including nephrotic syndrome. 342 Lomustine 10mg/40mg/100mg Anticancer. August-1980 Capsule 343 Fenpipramide Methobromide October-1980 and P-Piperidinoethoxy o- carbomethoxy benzophenone Hydrochloride (Bulk) 344 Azatadine Maleate 1mg Tablet Anti-allergic- indicated for the November-1980 symptomatic relief of allergic conditions such as hay fever, vasomotor rhinitis, urticaria, pruritus of allergic origin. 345 Flavoxate Hydrochloride Antispasmodic- indications for November-1980 100mg Tablet relief of dysuria, urgency, nocturia, supropubic pain, frequency, incontinence prostatitis, urethritis, urethrocystitis, uretheotrigentis, vesico urethral spasms. 346 Econazole Nitrate 1% Cream Topical antifungal & December-1980 antibacetrial agent- All fungal skin infections due to dermatophytes once vaginal candidiases. 347 Econazole Nitrate 150mg Topical antifungal & December-1980 Vaginal Tablet antibacetrial agent- All fungal skin infections due to dermatophytes once vaginal candidiases. 348 Cephalothin Sodium (Bulk) Cephalosporin antibiotic- in December-1980 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.

Note: The above list of approved New Drugs is prepared as per the records available with this office. If discrepancy is observed, the same may be brought to the notice of this office along with documentary evidence for necessary action.