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List of Approved Drug for Marketing in India
from 01.01.2009 to 30.12.2009)


S.No. Drug Name Indication Approval Date
151 Calcipotriol Gel 0.005%                        (additional dosage form) For the treatment of moderate plaque psoriasis in adults 3.10.2009
152 Lamotrigine MR Tablets 150mg (Addl. Strength) same as approved 3.10.2009
153 Metoprolol Tartrate ER Tablet 75mg                                                  (additional strength) same as approved 3.10.2009
154 Valganciclovir Powder for Oral Solution 50mg/ml For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk 9.10.2009
155 Dexketoprofen Trometamol Gel 12.5mg/gm For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle 13.10.2009
156 Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg For the treatment of mild to moderate severe Alzheimer's Dementia 15.10.2009
157 Dexketoprofen Trometamol Injection 50mg/2ml Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain. 22.10.2009
158 Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication) Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 22.10.2009
159 Levosulpride ER Tablet 100/150/200mg For the treatment of depression and schizophrenia in adults 27.10.2009
160 Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup Additional strength 27.10.2009
161 Propofol 10 mg+ Lignocaine 2.5 mg per ml injection Additional strength 27.10.2009
162 Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets For the treatment of diabetic neuropathy 27.10.2009
163 Olmesartan (20/40mg )+  Atorvastatin 5/10/20mg film coated tablets For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients 27.10.2009
164 Deltamethrin (0.50% m/v) and Piperonyl Butoxide  (2.0% m/v) per ml Pour–On Solution Ready to use pour-on for cattle, sheep and goats.  
1. For use in Cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g. house flies, to kill lice and protection against blackflies.
2. For use in sheep and goats for controlling Karoo paralysis, bont- legged and red-legged ticks
165 Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets For the treatment of adult patients with osteoarthritis of knee and/or hip joints 03.11.2009
166 Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets Additional strength  4.11.2009
167 Propofol 1% for injection (Additional Indication) 1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care 5.11.2009
168 Rupatadine 10 mg + Montelukast 10 mg Tablets For the management of seasonal allergic rhinitis (SAR) 10.11.2009
169 Eperisone 50 mg + Paracetamol 500 mg Tablets For improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only  10.11.2009
170 Lafutidine Tablets ....5mg/10mg.  For the treatment of:
• gastric ulcers, duodenal ulcers and stromal ulcers
• gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis.
171 Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml  1. Tablets 0.1mg & Injection 0.3-- for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer 
2. Tablets 2.5mcg & 5mcg--- for the treatment of diarrhoea predominant irritable bowel syndrome.
172 Tadalafil tablet 20 mg (Additional Indication) For the treatment of pulmonary arterial hypertension 14.11.2009
173 Flurbiprofen Sodium 0.03% Ophthalmic solution USP for the reduction of post-operative inflammatory condition 14.11.2009
174 Dexmedetomidine HCl Injection (Additional Indication) Sedation of non-intubated patients prior to and/or during surgical and other procedure 14.11.2009
175 Paliperidone ER tablet 12 mg (Additional Strength) Same as approved 14.11.2009
176 1) Triticum Vulgare Topical Cream      Each 100gm of cream contains:
Aqueous extract of Triticum Vulgare (dry residue 200mg / 100ml) ..... 15gm
2-phenoxyethanol Eur. Ph.....1gm 
2) Triticum Vulgare Vaginal Pessary Each 3.5gm of vaginal pessary contains:
Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm
2-phenoxyethanol Eur. Ph.....0.04gm
1) Triticum Vulgare Cream is indicated for the treatment of ulcers and bed sores.
2) Triticum Vulgare Vaginal Pessary is indicated for the treatment of phlogistic and dystrophic disorders of the female genital tract. 
177 Febuxostat Tablets 80mg / 120mg For treatment of chronic hyperuricemia in conditions where urate depression has already occured (including a history, or presence of tophus and /or gouty arthritis). 14.11.2009
178 Euphorbia Prostrata Dry Extract :100mg tablet (addl. Indication) For the treatment of 3° and 4° haemorrhoids (Addl. Indication). 14.11.2009
179 Euphorbia Prostrata dry extract ethanolic 80%v/v[(35-70):1] cream 1% w/w For the treatment of 1° and 2° internal haemorrhoids. 14.11.2009
180 Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules  For the treatment of acute diarrhoea in children  14.11.2009
181 Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution For the local application in relieving pain in acute low backache, tendonitis, tenosinovitis and sprains 17.11.2009
182 Diacerein Modified Release Capsule 100mg Symptomatic treatment of osteoarthritis of knee & hip 20.11.2009
183 Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets  For the treatment of essential hypertension  24.11.2009
184 Maraviroc Tablets 150mg/300mg. For the treatment of patients infected with CCR5- trophic HIV-1. 25.11.2009
185 S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis 25.11.2009
186 Tacrolimus Granules for oral suspension 0.2/1 mg per sachet Prophylaxis of transplant rejection in kidney, liver or heart allograft recipient 26.11.2009
187 Rifaximin Dispersible Tablet 200mg For infections diarrhoea in adults 26.11.2009
188 Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg Indicating for condition required Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction 26.11.2009
189 Cinitapride Hydrogen Tartrate ER Tablet 3mg For the treatment of gastroesophageal reflux disease (GERD) and functional inconveniences of the gastrointestinal motility 26.11.2009
190 Sevelamer Carbonate (Additional Indication) for control of serum phosphorus in patients with chronic kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl 26.11.2009
191 Oxcarbazepine Tablets (Additional Indication)150/300/600 mg Monotherapy in the treatment of partial seizures in children ages 4-16  26.11.2009
192 Ketoprofen plaster 30 mg (7cm X 10 cm) for the relief of musculoskeletal pain & inflammation 11.12.2009
193 Acipimox Capsules 250mg. As adjunctive therapy to diet and weight loss in the treatment of type IIa, IIb and IV lipid disorders. 26.11.2009
194 Amisulpiride SR Tablet 100 mg Same as approved 27.11.2009
195 Mycophenolate Sodium Enteric coated tablet 540 mg (Additional Strength) Same as approved 29.10.2009
196 Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension For the treatement of post operative steriod responsive inflammatory ocular infections or risk of bacterial ocular infections exists  1.12.2009
197 Ropinirole ER tablet 2/4/8mg for the treatment of signs & symptoms of idiopathic Parkinson's disease 3.12.2009
198 Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional Strength) same as approved 4.12.2009
199 Lornoxicam ER Tablet 8 mg (Additional Strength) same as approved 11.12.2009
200 Flurbiprofen plaster 20 mg (7cm X 10cm) for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder 11.12.2009
201 Carvedilol Phosphate ER tablet 10/20/40/80mg 1. Mild to severe chronic heart failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension 11.12.2009
202 Halometasone monohydrate  0.05% w/w + Fusidic acid 2.00% w/w cream For the treatment of acute and chronic infected eczematous dermatitis 15.12.2009
203 Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets For the treatment of type II diabetes mellitus associated with dyslipidemia  17.12.2009
204 Betahistine Di hydrochloride CR capsule 24/32/48mg indicated in the treatment of Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss 17.12.2009
205 Gefitinib tab 250mg (Additional Indication) Indicated for the first line treatment of patients with locally advanced or metastatic non small cell lung cancer (NSLC) who have activating mutationof the EGFRTK". 18.12.2009
206 Midazolam Hcl Syrup 2mg/ml For selection,anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedure or before induction of anesthesia. 18.12.2009
207 Guaiphenasin Syrup 133mg/5ml For the treatment of productive cough accompanied by phlegm 18.12.2009
208 Balofloxacin Tablet 100mg for the treatment of uncomplicated urinary tract infectins (such as cystitis and urethritis) 22.12.2009
209 Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray For symptomatic treatment of nasal congestion with running nose (rhinorrhea) 23.12.2009
210 Doxofylline 400 mg + Ambroxol 30 mg Tablets For the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate  23.12.2009
211 Ribavirin Capsules 200mg (Addl. Strength) Indicated in combination with peg interferon alpha-2b for the treatment of naïve adult patients with chronic hepatitis C with clinically stable HIV co-infection. 24.12.2009
212 Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder Inhalation For the treatment of patients with bronchial asthma and COPD, where the use of combination is found appropriate  30.12.2009
213 Chlorohexidine Gluconate Gel 0.2% For the prevention of Plaque and treatment of gengivitis. 30.12.2009
214 Chlorohexidine Gluconate Mouth wash 0.1% For the prevention of Plaque and treatment of gengivitis. 30.12.2009



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