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FDCA, License Procedure
Home HOD Food & Drug Commissioner FDCA, License Procedure New Drugs Approval
New Drugs Approval
 
LIST OF DRUGS APPROVED DURING 1999-2005
 
Sl.No. Name of Drug Pharmacological Classification Date of Approval
1 Glimepiride Antidiabetic agent 22.01.99
2 Mycophenolate Mofetil Immunosuppressant 07.02.99
3 Meloxicam NSAID 16.02.99
4 Tetrabenazine Pre-Synaptic monoamine depleting agent 10.03.99
5 Doxazosin Mesylate Antihypertensive agent 11.03.99
6 Nafarelin Acetate Antiendometriotic agent; gonadotropin inhibitor 17.03.99
7 Milrinone Lactate Inj. Cardiotonic 17.05.99
8 Brimonidine Tartrate Alpha2-adrenoreceptor agonist, adjunct in glaucoma 18.05.99
9 Nabumetone NSAID 18.05.99
10 Zolpidem Sedative-Hypnotic 28.05.99
11 Basiliximab Inj. Immunosuppressant 28.05.99
12 Topotecan Hydrochloride Antineoplastic 15.06.99
13 Fludarabine Phosphate IV Inj. Antineoplastic 26.06.99
14 Zuclopenthixol Acetate Antimaniac & antischizoprenic 29.07.99
15 Piperacillin - Tazobactam Inj. Antibiotic 13.08.99
16 Topiramate Antiepileptic 23.08.99
17 Eptifibatide Platlet Aggregation Inhibitor 25.08.99
18 Atorvastatin Antihyperlipidemic; HMG- CoA reductase inhibitor 17.09.99
19 Sulpiride Antipsychotic 26.10.99
20 Bambuterol Bronchodilator 13.12.99
21 Bulaquine Antimalarial 21.12.99
22 Fenofibrate Lipid lowering agent 22.12.99
23 Sibutramine Hydrochloride Appetite suppressant 23.12.99
24 Oxiconazole Antifungal 17.01.2000
25 Temozolomide Antineoplastic 17.01.2000
26 Olanzapine Antipsychotic 27.01.2000
27 Fluvoxamine Maleate Antidepressant 21.02.2000
28 Celecoxib NSAID 22.02.2000
29 Nevirapine Anti HIV 06.03.2000
30 Repaglinide Antidiabetic 23.03.2000
31 Ganciclovir Antiviral 05.04.2000
32 Trapidil Adjunct in angioplasty 11.05.2000
33 Cerivastatin Lipid lowering agent 11.05.2000
34 Rofecoxib NSAID 26.06.2000
35 Irbesartan Antihypertensive 26.06.2000
36 Rosiglitazone Maleate Antidiabetic 28.06.2000
37 Granisetron Antiemetic 05.07.2000
38 Rituximab Antineoplastic 10.07.2000
39 Trastuzumab Antineoplastic 10.07.2000
40 Rosiglitazone Antidiabetic 14.07.2000
41 Moclobemide Antidepressant 28.07.2000
42 Candesartan Antihypertensive 31.08.2000
43 Venlafaxine Hdrochloride Antidepressant 18.09.2000
44 Paroxetine Hydrochloride Antidepressant 04.10.2000
45 Iomeprol Contrast medium 05.10.2000
46 Capecitabine Antineoplastic 12.10.2000
47 Daclizumab Immunosuppressive agent 12.10.2000
48 Pioglitazone Hydrochloride Antidiabetic 17.10.2000
49 Didanosine AntiHIV 15.11.2000
50 Octy.lonium Bromide Irritable bowel syndrome 12.12.2000
51 Pravastatin Lipid lowering agent 20.12.2000
52 Sildenafil Citrate Male Erectile Dysfunction 08.01.2001
53 Triflusal Platelet Aggregation Inhibitor 17.01.2001
54 Thymosin Alfa-1 Inj. Immunomodulator (for chronic Hepatitis-B) 17.01.2001
55 Vinorelbin Tartrate Inj. Antineoplastic aggregation inhibitor 17.01.2001
56 Broncho-Vaxom Antiasthamatic, immune boosting drug Feb, 2001
57 Indinavir Sulphate Antiviral (Anti-HIV) 01.02.2001
58 Butenafine HCl cream Antifungal 14.02.2001
59 Mirtazapine Antidepressant 14.02.2001
60 Clopidogrel Antithrombotic; platelet aggregation inhibitor 22.02.2001
61 Mosapride Prokinetic agent, GERD 12.03.2001
62 Donepezil HCl For Alzheimer's Dementia 20.03.2001
63 Bupropion SR Smoking cessation adjunct 10.04.2001
64 Raloxifene HCl Menopausal osteoporosis 04.05.2001
65 Efavirenz Anti-HIV 06.06.2001
66 Moxifloxacin Antibacterial 26.06.2001
67 Misoprostol Antiulcer agent 21.06.2001
68 Human Recombinant Granulocyte Colony Stimulating Factor Inj. Haemopoietic stimulant, antineutropenic 29.06.2001
69 Nelfinavir Mesylate Anti-HIV 02.07.2001
70 Ciprofloxacin 1g SR Antibacterial Aug, 2001
71 Tolterodine-L-Tartrate Overactive Bladder 13.09.2001
72 Ebastine Antiallergic 28.09.2001
73 Leflunomide Anti-rheumatoid Arthritis 01.10.2001
74 Citalopram Hydrobromide Antidepressant 03.10.2001
75 Gatifloxacin Antibacterial 03.10.2001
76 Linezolid Antibacterial 04.10.2001
77 Genirelix Antigonadotropin releasing hormone (fertility drug) 08.10.2001
78 Racecadotril Antidiarrhoel 10.10.2001
79 Cefdinir Antibacterial 10.10.2001
80 Iobitridol Contrast Medium 17.10.2001
81 Estemestane Antineoplastic 18.10.2001
82 Decapeptide For Vitiligo 22.10.2001
83 Oxcarbazepine Antiepileptic 30.10.2001
84 Desloratidine Antiallergic 30.10.2001
85 Zolendronic Acid For Hypercalcaemia 05.11.2001
86 Zafirlukast Antiasthmatic (Leukotriene Receptor Antagonist) 03.12.2001
87 Ropinirole Dopamine Agonist (for Parkinson's Disease) 03.12.2001
88 Esomeprazole Mag. Antiulcer 04.12.2001
89 Etanercept-Recomb. Antirheumatic, Tumor Necrosis Factor Receptor 07.12.2001
90 Imatinib Mesylate Anticancer 09.12.2001
91 Valsartan Antihypertensive 10.12.2001
92 Rabeprazole Antiulcer; Proton pump inhibitor 27.12.2001
93 Bimatoprost (Ophthalmic Sol.) Anti-Glaucoma 08.01.2002
94 Meropenem Inj. Beta-lactum Antibiotic 08.01.2002
95 Fosinopril Sodium Antihypertensive 10.01.2002
96 Divalproax Sodium Antiepileptic 17.01.2002
97 Zaleplon Sedative-Hypnotic 17.01.2002
98 Tizanidine SR Multiple Sclerosis 06.02.2002
99 Thymogen Inj. Anticancer 12.02.2002
100 Montelukast Sodium Antiasthmatic (Leukotriene Receptor Antagonist) 13.02.2002
100A Methyl Cobalamin Peripheral Neuropathy 13-02.2002
101 Mifepristone Progesterone Antagonist 13.02.2002
102 Dexarazoxane Injection Cardio Protective Agent 26.02.2002
103 Tranexamic Acid Antifibrinolytic 06.03.2002
104 Bicalutamide Anticancer 07.03.2002
105 Loteprednol Etabonate Ophtalmic Sol. Corticosteroid, ophthalmic anti-inflammatory 15.03.2002
106 Apraclonidine Ophthalmic Sol. Alpha 2-adrenoreceptor agonist 15.03.2002
107 Mizolastine Antiallergic 15.03.2002
108 Miltefosine For Kalazar 15.03.2002
109 Ziprasidone HCl For Schizophrenia 18.03.2002
110 ABACAVIR Anti – HIV 22.03.2002
110 Nadifloxacin Cream Antibacterial; antiacne 28.03.2002
111 Meloxicam Inj. (Vet) NSAID 02.04.2002
112 Mesalazine SR Bowel disease (inflammatory) 04.04.2002
113 Tamsulosin HCl For BPH 04.04.2002
114 Famciclovir Antiviral 11.04.2002
115 Nateglinide Antidiabetic 01.05.2002
116 Lercanidine HCl Antihypertensive 07.05.2002
117 Itopiride Capsules Gastro Prokinetic Agent 09.05.2002
118 Alprostadil Injection For Erectile Dysfunction 09.05.2002
119 Vimpocetine Vasodilator 13.05.2002
120 Quetiapine Fumerate Antipsychotic 31.05.2002
121 Isotretinoin Soft Gel Cap. For Acne vulgaris 21.06.2002
122 Nebivolol HCl Antihypertensive 12.07.2002
123 Sirolimus Immunosuppressant 15.07.2002
124 Drotrecogin alpha For severe sepsis 23.07.2002
125 Pygenum Africum For BPH 30.07.2002
126 Valdecoxib NSAID 01.08.2002
127 Thalidomide For Leprosy 12.08.2002
128 S (-) Amlodipine Besylate Anti-hypertensive 16.08.2002
129 Cabergoline For hyperprolactemia 05.09.2002
130 Butarphenol Tartarate Opoid Analgesic 11.09.2002
131 Gemtuzumab For Myeloid Leukemia 12.09.2002
132 Quinapril Anti – Hypertensive 19.09.2002
133 Valacyclovir Anti-viral 25.09.2002
134 Fosphenytoin Sod. Anti-Epileptic 01.10.2002
135 Ceftiofur Sodium & Ceftiofur HCl Antibiotic (For Veterinary Use) 08.10.2002
136 Metaxalone Muscle Relaxant 08.10.2002
137 Meglumine gadoteric Contrast media 16.10.2002
138 Cefepine HCl Anti-Biotic 30.10.2002
139 Acamprosate Calcium For Alcohol dependency 30.10.2002
140 Aztreonam Anti-Bacterial 01.11.2002
141 Tegaserod Maleate For irritable bowel syndrome 01.11.2002
142 Parecoxib Inj. NSAID 01.11.2002
143 Balsalezide Disodium For ulcerative colitis 12.11.2002
144 Cefetemet-piroxil Antibacterial 14.11.2002
145 Telmisartan Antihypertensive 25.11.2002
146 Levocetrizine Anti-Histaminic 12.12.2002
147 Poractant a For respiratory distress in preterm babies 24.12.2002
148 Reboxetine Anti-depressant 31.12.2002
149 Cefprozil Antibiotic 10-01-2003
150 Cilostazol For intermittent claudication. 23-01-2003
151 Escitalopram Oxalate. Anti depressant 24.01.2003
152 Anastrazole Anti cancer 10.02.2003
153 Rizapriptan Anti migrain 27.02.2003
154 Gadobenate(Dimeglumine IV Injection) MRI Contrast Medium 07.03.2003
155 Tacrolimus Ointment Immuno-modulator 10-03-2003
156 Metolazone Diuretic 23.04.2003
157 Tiotropium Bromide Anti asthematic 16.04.2003
158 Gadoversetamide Injection MRI Contrast Medium 04.06.2003
159 Torsamide Diuretic 09.06.2003
160 Cyproterone Tablet For Prostatic Cancer 10-06-2003
161 Aripiprazole Anti schizophrenia 11.06.2003
162 Azelaic Acid Anti-Acne 08-07-2003
163 Bendrofluazide Diuretic 24.07.2003
164 Imipenem +Cilastatin Anti-Bacterial 25-07-2003
165 Vinpocetin Anti-pychotic 01.08.2003
166 Tirofiban HCl I.V Anti-Platelet 12.08.2003
167 Teriparatide For Osteoporosis 04-09-2003
168 Cladribine Anti-Cancer 09-09-2003
169 Tadalafil For Erectile Dysfunction 11-09-2003
170 S-Atenolol Anti-hypertensive 11-09-2003
171 Rosuvastatin Lipid lowering Agent 12-09-2003
172 Tazarotene Anti-Acne 12.09.2003
173 Aceclofenac NSAID 15-09-2003
174 Ibopamine HCl Opthalmic 03-10-2003
175 Trandolapril Anti-Hypertensive 03-10-2003
176 Dorzolamide Opthalmic 03-10-2003
177 Fenoverine Anti-spasmodic 08-10-2003
178 Risedronate Sodium For Osteoporosis 17-10-2003
179 Fondaparinax Sodium LMWH 22-10-2003
180 Metadoxine For Hepatic Disorder 24-10-2003
181 Valgancyclovir For CMV 20-11-2003
182 Isopropyl Unoprostone Ophthalmic 25-11-2003
183 Amorolfine Anti-Fungal 25-11-2003
184 Fluvastatin Sodium Lipid Lowering Agent 25-11-2003
185 Modafinil For sleeping disorder 15-12-2003
186 Sufentanil Citrate Anesthetic Agent 17-12-2003
187 Ezetimibe Lipid Lowering Agent 18-12-2003
188 Dutasteride For BPH 16-02-2004
189 Gefitinib Anti-cancer 17-02-2004
190 Imidapril Anti-hypertensive 23-02-2004
191 Adefovir Dipivoxil Anti-Viral (Hepatitis-B) 04-03-2004
192 Etoricoxib NSAID 05-03-2004
193 Diacerein For Osteoarthritis 12-03-2004
194 Nitazoxanide Anti-Diarrhoeal 17-03-2004
 
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