LIST OF APPROVED DRUG FROM 01.01.08 TO 31.12.08

S. No. Drug Name Indication Approval Date
1 Me-salicylate 30% + Menthol 10% + camphor 4% Cream For temporary relief from pain, swelling & inflammation due to musculoskeletal disorder 29.11.07
2 Voglibose 0.2mg/0.3mg tablet (Mouth dissolving) For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic drug or insulin preparation in addition to diet and or exercise do not result in adequate glycemic control. 28.12.07
3 Hydroxychloroquine 400mg tablets (Additional Strength) Same as Approved 31.01.08
4 ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength) Same as Approved 02.01.08
5 Halobetasol 0.05% + Clotrimazole 1.0% cream For the treatment of steroid responsive fungal infections including eczema and psoriasis 04.01.08
6 Citicholine Syrup 750mg/5ml For the treatment of disturbance of consciousness resulting from head injuries, brain operation and acute stage of cerebral infarction in adults only 04.01.08
7 Levodopa 200mg + Carbidopa 50mg C.R. tablet For Parkinson's Disease 08.01.08
8 Nanocrystalline Silver Gel 0.002% For the treatment of burns and wound infections 04.01.08
9 Cinitapride (as hydrogen tartrate) 1mg tablet For the treatment of gastroesophageal reflux disease and functional inconveniences of the gastrointestinal motility 04.01.08
10 Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet For the treatment of adult patients with HIV infection 07.01.08
11 Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet For the treatment of Urinary tract infections, respiratory tract infections, biliary tract infections in adult patients prone to antibiotic associated diarrhoea 07.01.08
12 D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) Same as Approved 07.01.08
13 Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) For the treatment of lower respiratory tract infection caused by pseudomonas aeruginosa 08.01.08
14 Atazanavir 300mg capsules (Additional strength) Same as approved 08.01.08
15 Ertapenem for injection 1gm/vial (additional indication) For the prophylaxis of surgical site infections following elective colorectal surgery 15.01.08
16 Vildagliptin Tablets 50mg/100mg As an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes mellitus 18.01.08
17 Atorvastatin 10mg + Aspirin 75/150mg Capsules For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease 18.01.08
18 Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets For the treatment of acute migraine 22.01.08
19 Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C.R. tablet (Additional Strength) Same as Approved 24.01.08
20 Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 1000/500/250mg per vial of injection For serious CRTI, uncomplicated and complicated UTI, Uncomplicated skin & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection. 24.01.08
21 Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication) Ovarian cancer, non-small cell lung cancer and AIDS related Kaposis Sarcoma 22.01.08
22 Sorafenib tablets 200mg (Additional Indication) For hepatocellular Carcenoma 22.01.08
23 Zanamavir inhalation powder 5mg/blister (Additional Indication) For prophylaxes and treatment of both influenza A & B in adults and children (greater than or equal to 5 years) 22.01.08
24 Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional Indication) For the prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplantation 23.01.08
25 Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IU For the treatment of osteoporosis in post-menopausal women 23.01.08
26 Aceclofenac injection 150mg/ml For short term treatment of pain due to post operative and post traumatic cases 23.01.08
27 Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions. 25.01.08
28 Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate- 750mg CR tablet (Additional Strength) Same as Approved 24.01.08
29 Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet For the treatment of acute pain in adults 24.01.08
30 Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength) Same as Approved 24.01.08
31 Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection For the treatment of infection caused by sensitive organisms viz. lower RTI, complicated UTI, Septicemia, bacteremia 24.01.08
32 Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet For the treatment of Type-II diabetes associated with mixed dyslipidemia 25.01.08
33 Salicylic acid 10mg/20mg (Foaming facewash solution) For the treatment of acne vulgaris 28.01.08
34 Ozagrel Hcl. Tablets 100mg/200mg For the treatment of bronchial asthma 28.01.08
35 Rivastigmine transdermal patch (each patch of 5m2, 10m2,15m2 & 20m2 contain Rivastigmine base 9/18/27/36mg respectively For the treatment of patients with mild to moderately severe dementia of the Alzheimer type and dementia associated with Parkinsons disease 28.01.08
36 Daptomycin powder for concentrate for solution for infusion (350mg/500mg per vial) For the treatment of complicated skin and skin structure infections and for staphylococus aureus bloodstream infections (bacteremia) 28.01.08
37 Dextromethorphan Orodispersible strip 5.5mg/11mg For the relief of persistent dry irritating cough in adult patients only 28.01.08
38 Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection For the treatment of acute colicky pain in adults 28.01.08
39 Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops For decrease of intraocular pressure in patients with open angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta blockers or prostaglandin analogues 28.01.08
40 Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea 30.01.08
41 Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea 31.01.08
42 Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calcium Pantothenate25mg+Folic Acid 1.5mg+Zinc oxide22.5mg+Chromium picolinate65mcg+Inositol10mcg+Lutein5mg capsule  For Vitamins and Minerals deficiency states in adult patients 30.01.08
43 Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid0.75mg capsule  For Vitamins and Minerals deficiency states in adult patients 30.01.08
44 Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg + Pyridoxine3mg + Biotin5mg + Folic acid 1.5mg capsule  For Vitamins deficiency states in adult patients 30.01.08
45 Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules For the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in adult patients prone to antibiotic associated diarrhoea 30.01.08
46 Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules As 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately 31.01.08
47 Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 10mg tablets For the treatment of patient with both essential hypertension and hypercholesterolemia 28.01.08
48 Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form) For allergic rhinitis & chronic urticaria 28.01.08
49 Oseltamivir 30mg & 45mg Capsules (Additional Strength) Same as Approved 28.01.08
50 Fondaparinax Sodium injection (Additional Indication) Treatment of acute coronary syndrome (ACS) with and without ST-segment elevation 28.01.08
51 Camostat Mesylate tablets 100mg For remission of acute symptoms of chronic pancreatitis and post-operative reflux esophagitis 29.01.08
52 Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe For intradermal implantation and facial soft tissue agumentation 30.01.08
53 Ursodeoxycholic acid tablets 600mg For the treatment of patients with chronic cholestatic liver disease 30.01.08
54 Dalteparin Sodium Injection(Additional Indication) For the extended treatment of symptomatic venous thromboembolism (VTE) proximal deep thrombosis (DVT) and/or pulmonary embolism (PE), to reduce the recurrence of VTE in patients with cancer 30.01.08
55 Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream For the topical treatment of bacterial and fungal infections 30.01.08
56 Exenatide injection (Each 2ml vial contains- Exenatide 5mcg/10mcg per 0.2ml ) (Additional Strength) For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who have not achieved adequate glycemic control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas 30.01.08
57 Diclofenac Sodium 50mg + Paracetamol 500mg tablets For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis 30.01.08
58 Gabapentin SR 600mg tablets As adjunctive therapy in the treatment of partial seizures of epilepsy 30.01.08
59 Memantine 5mg /10mg + Donepezil 5mg Tablets For moderate to severe Alzheimer's disease 31.01.08
60 Doxifluridine Capsules 100mg/200mg For carcinoma of the stomach, colon, rectum, breast, uterine, cervix and bladder 31.01.08
61 Haemodialysis Powder/Liquid Form containing citrate For use for patients being treated by hemodialysis 31.01.08
62 Carmustine (polifeprosan 20 with carmustine Implant (Wafer) 1:- In newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. 2:- In recurrent glioblastoma multiforme patients as an adjunct to surgery 31.01.08
63 Cimetropium Bromide tablet 50mg For the treatment of irritable bowel syndrome 31.01.08
64 CyclobenzaprineHcl. Tablets 5mg/10mg As adjunct to rest and physical therapy for relief of muscle spasm associated with acute painful musculoskeletal conditions 31.01.08
65 Sertaconazole Nitrate Cream 2%, For the topical treatment of the superficial mycosis like dermatophytosis 31.01.08
66 Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength) Same as Approved 31.01.08
67 Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency 31.01.08
68 Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules) For the treatment of respiratory tract infection, skin and soft tissue infections & antibiotics associated diarrhoea in adult patients 31.01.08
69 Halobetasol 0.5mg + Miconazole 20mg per gram Cream For steroid responsive dermatoses associated with superficial fungal infection of skin 31.01.08
70 Montelucast 10mg + Levocetirizine 5mg film coated tablets For the treatment of allergic rhinitis in adults only 31.01.08
71 Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel For short term intermittent treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance including use of sun screen 31.01.08
72 Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 60mg + Menthol 1mg (per 5ml) Syrup For the treatment of common cold and cough associated with fever 31.01.08
73 Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules For treatment of painful inflammatory conditions associated with gastroduodenal ulcers 31.01.08
74 Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler As third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately 31.01.08
75 VSL # (Combination of lactic acid bacteria (VSL # 3) For the treatment of irritable bowel syndrome 31.01.08
76 Clostimethate Sodium of 1,00,000IU Injection For the treatment of serious infection caused Gram-Ve bacteria including LRTI, UTI, where commonly used anti bacterial agent may be infective because of bacterial resistance 31.01.08
77 Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength) Same as Approved 20.02.08
78 Metronidazole CR tablet 600mg For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis 21.02.08
79 Quetiapine fumarate SR tablets for the additional indication "acute manic episode associated with bipolar disorder 21.02.08
80 Atorvastatin Calcium 80mg tablets (Additional Strength) additional Strength (it should not be used routinely because of increased risk of adverse events. It should be reserved for patients who are considered to be at higher risk after careful risk assessment 25.02.08
81 Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tablet For the treatment of haemorrhoid 29.02.08
82 Amtolmetin Guacil tablets 600mg For the treatment of osteoarthritis & rheumatoid arthritis 07.03.08
83 Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.005%) (additional strength) For lowering of IOP in patients with open angle glaucoma occular hypertension 07.03.08
84 Methoxsalen USP-20mg Tablet 1:- For repigmentation of idiopathic vitiligo alongwith phototherapy. 2:- For symptomatic control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy 07.03.08
85 Cefditoren pivoxil 400mg tablets (Additional Strength) Same as Approved 11.03.08
86 Doxofylline ER tablets 400mg/800mg (addl. Strength) For the treatment of bronchial asthma & COPD in adults 12.03.08
87 Betamethasone 0.05% +Miconazole 2% Cream For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin 12.03.08
88 Premetrxed disodium injection 100mg/vial (Additional Strength) Same as Approved 12.03.08
89 Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension For gastric ulcer, duodenal ulcer, and GERD 12.03.08
90 Mecobalamin 1000mcg+ Alpha Lipoic Acid 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ Inositol 100mg + Benfotiamine 100mg capsule  For the treatment of diabetic neuropathy 19.03.08
91 ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) Same as Approved 19.03.08
92 Temozolamide capsules 140mg/180mg (Addl. Strength) Same as Approved 31.03.08
93 Amisulpiride 300mg tablets (Additional Strength) Same as Approved 20.03.08
94 Nifedipine SR Tablets 10mg/20mg For the treatment of essential hypertension 24.03.08
95 Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrup For symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis 26.03.08
96 Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis 26.03.08
97 Boswellia Serrata 0.05gm/gm of Cream For the treatment of mild to moderate psoriasis 28.03.08
98 Etoricoxib injection 90mg/ml For short term use in acute painful condition in adults only 28.03.08
99 Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) Oral contraceptive in women 28.03.08
100 Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets For symptomatic treatment of acute rhinosinusitis 28.03.08
101 Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg For the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain 28.03.08
102 Nepafenac Opthalmic suspension (1mg/ml) For the treatment of pain and inflammation associated with cataract surgery 31.03.08
103 Hylan GF 20 Injection (Synvisc) (Additional Indication) For pain management in patients suffering with osteoarthritis of the knee, hip, shoulder and ankle 31.03.08
104 Docetaxel injection conc. For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer 31.03.08
105 Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D-Panthenol IP 50mg per 2 ml of injection For peripheral neuropathy 31.03.08
106 Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength) Same as Approved 01.04.08
107 Nicardipine Hcl. Injection 2.5mg/ml For short-term treatment of hypertension when oral therapy is not feasible or not desirable 07.04.08
108 Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength) For the treatment of acute pain in adults 08.04.08
109 Diacerin 50mg + Aceclofenac 100mg tablets For the treatment of adult patients with osteoarthritis of knee and or hip joints 11.04.08
110 Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) Same as Approved 16.04.08
111 Live freeze-dried lactic acid bacteria and bifidobacteria capsules For the treatment of irritable bowel syndrome 10.04.08
112 Miltefosin Capsule 10mg/50mg (Additional Indication) Treatment of cutaneous leishmaniasis 16.04.08
113 Silver Wound Dressing As an antimicrobial barrier for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic) 16.04.08
114 Diacerin 50mg + Glucosamine sulphate 500mg tablets. For the treatment of adult patients with osteoarthritis of knee and hip joints 21.04.08
115 Clostridium Botulinum type-A toxin haemagglutinin complex (Additional Indication) For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy 22.04.08
116 Fluconazole Dispersible tablets 50mg For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy 22.04.08
117 Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication) In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy 22.04.08
118 Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets As an adjunct to diet & exercise to improve glycemic control in patients with type-two diabetes mellitus 28.04.08
119 Lansoprazole for injection 30mg/vial For short term treatment of errosive esophagitis when patients are unable to take the oral formulation 28.04.08
120 Naproxen Suspension 125mg/5ml For the treatment of RA in children 5 years of age and above 28.04.08
121 Sevelamer Carbonate 400mg/800mg tablets & sachet 400mg/800mg For control of serum phosphorus in patients with chronic kidney disease on dialysis 28.04.08
122 Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tablets For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD 28.04.08
123 Pantoprazole Sodium (With Sodium bicarbonate as buffer) 20mg/40mg tablets For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD 28.04.08
124 Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml For the treatment of community acquired pneumonia, acute exacerabation of chronic bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis 29.04.08
125 Pregabalin capsules (Addl. Indication) management of fibromyalgia syndrome 29.04.08
126 Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength) Same as Approved 08.05.08
127 Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets For the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy . 08.05.08
128 Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets For diabetes insipidus and noctural emuresis 08.05.08
129 Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength) Same as Approved 14.05.08
130 Lecithin Liquid (each 5 ml contains lecithin 500mg equivalent to essential phospholipids 250mg For alcoholic liver disease, drug induced hepatitis 14.05.08
131 Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength) For the treatment of plaque psoriasis 14.05.08
132 Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solution For the topical treatment of acne vulgaris 14.05.08
133 Deflazocort 24mg tablets (Additional strength) Same as Approved 14.05.08
134 Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection (additional strength) For use as a surgical aid in anterior segments procedure including catract extraction & intra-ocular lens implantation 14.05.08
135 Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets For the treatment of GERD, gastric and duodenal ulcer, Zollinger-Ellison syndrome 14.05.08
136 Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg Tablets For coexisting essential hypertension & hyperlipidemia 22.05.08
137 Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet. For the treatment of adult patients with major depressive disorder 22.05.08
138 Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets For hypertension in patients whose blood pressure is not adequately controlled in monotherapy 28.05.08
139 Metolazone 2.5mg + Ramipril 2.5mg/5mg For essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy 28.05.08
140 Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules For the treatment of secondary hyperthyroidism in patients with chronic kidney disease on dialysis 29.05.08
141 Acebrophylline capsules 100mg For the treatment of adult patients with chronic obstructive pulmonary disease and bronchial asthma 29.05.08
142 Sofalcone Capsule (100mg/50mg) For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute exacerbation of chronic gastritis 02.06.08
143 S(+) Etodolac ER tablets 200mg/300mg For the relief of pain and inflammation in patients with rheumatoid arthritis and osteoarthritis 02.06.08
144 Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets For the treatment of adult patients with signs & symptoms of acute painful conditions 02.06.08
145 Sodium Hyaluronate injectable gel (each 0.6ml. 1ml pre filled syringe contains, sodium Hyaluronate 20mg/ml, 22.5mg/ml For intradermal implantation and facial soft tissue augmentation 03.06.08
146 Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension For invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin B therapy 03.06.08
147 Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules For the treatment of Gastroeasophageal Reflux Disease (GERD) in patients not responding to dexrabeprazole alone 09.06.08
148 Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets For acute low back pain & other musculoskeletal painful and inflammatory condition in adults 11.06.08
149 Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) For the treatment of lower respiratory tract infection in children 24.06.08
150 Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength) Same as Approved 24.06.08
151 Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg+ Benfotiamin100mg + Pyridoxine 50mg tablets For the treatment of diabetic Neuropathy 03.07.08
152 Ivabradine (Hcl.) 5mg/7.5mg Tablets For the treatment of chronic stable anginapectoris in patients with normal sinus rhythm who have a contraindication or intolerance for Beta-blockers 03.07.08
153 Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule For the treatment of diabetic Neuropathy 04.07.08
154 Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion) Indicated to meet daily requirement of nitrogen (amino acids), energy (glucose) for patients needing parentral Nutrition 08.07.08
155 Temoporfin 1mg/ml Injection (Additional Strength) Same as Approved 08.07.08
156 Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100ml For the treatment of RTI, UTI and abdominal infections in adults 09.07.08
157 Metoprolol ER + Amlodipine tablets (Additional Indication) For coronary artery disease/ischaemic lheartt disease 16.07.08
158 Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets   18.07.08
159 Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tablets For the treatment of type_II diabetes mellitus when single drug therapy alongwith diet, exercise do not result in adequate glycemic control 21.07.08
160 Testosterone Undecanoate 250mg/ml Injection For Testosterone replacement therapy of male hypogonadism when testosterone dificiency has been confirmed by clinical feature or biochemical tests 22.07.08
161 Abatacept powder for injection 250mg/vial For adult patients with severe active rheumatoid arthritis who had an inadequate response to one more DMARDs such as methotixate or TNF antagonists 22.07.08
162 Actarit 100mg Tablets For the treatment of rheumatoid arthritis patients 22.07.08
163 Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets For the treatment of HIV infection in adults 23.07.08
164 Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) Same as Approved 23.07.08
165 Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop For reduction of part operative inflammatory condition of eyes 24.07.08
166 Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops For the reduction of post operative inflammatory conditions of the eye 24.07.08
167 Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup (Additional strength) Same as Approved 25.07.08
168 Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication) For the treatment of secondary hyperparathyroidism in patients with stage 3 or stage 4 chronic kidney disease  05.08.08
169 Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength) Same as approved 05.08.08
170 Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) Same as approved 05.08.08
171 Olopatadine Nasal Spray (0.6%) For the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older 05.08.08
172 Loxoprofen Sodium tablet (60mg) For the symptomatic treatment of pain and inflammation condition in patients with osteoarthritis 14.08.08
173 Dexibuprofen Suspension 50mg/5ml For the treatment of mild to moderate pain, reduction of fever 14.08.08
174 Bromfenac Sodium Eye Drop (0.09%) For the treatment of postoperative inflammation & reduction of postoperative ocular pain in patients who have undergone cataract extraction 14.08.08
175 Ceftriaxone + Sulbactam injection (Additional Indication) for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis 18.08.08
176 Citicoline Chewable tablet (500mg) For the treatment of disturbance of consciousness as resulting from head injuries , brain operation and acute stage of cerebral infraction in adult only 18.08.08
177 Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml) For the treatment of productive cough 18.08.08
178 Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) For the treatment of iron deficiency anaemia 18.08.08
179 Cyclobenzaprine 7.5mg tablets (Additional Strength) Same as approved 18.08.08
180 S-Metoprolol Succinate Oral Solution (Each Ml contains: S-Metoprolol Succinate 9.5mg equal to S-Metoprolol Tartrate 10mg) For the treatment of haemo-dynamically stably patients with definite or suspected acute Myocardial Infarction to reduce cardio-vascular mortality. 19.08.08
181 Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional Indication) In combination with bortezumab for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant 23.08.08
182 Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg) As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental infections, and halitosis 25.08.08
183 Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml)  Same as approved 25.08.08
184 Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg) For the treatment of oedema associated with congestive heart failure, cirrhosis and nephritic syndrome 25.08.08
185 Tretinoin Microsphere Gel (0.1% W/V) For topical treatment of acne vulgaris 26.08.08
186 Misoprostol 50Mcg tablet (Additional Strength) Same as approved 26.08.08
187 Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form) Same as approved 27.08.08
188 Guaiphenesin ER Tablet (600mg) For the treatment of productive cough accompanied by phlegm 28.08.08
189 Clopidogrel 300mg Tablet (addl. Strength) As approved 02.09.08
190 Capecitabine 150/500mg Tablets (addl. Indication) For the treatment of patients with metastatic colorectal cancer 02.09.08
191 Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength) For the treatment of patients with HIV infection 08.09.08
192 Ixabepilone lyophilized powder inj. 15mg/45mg per vial in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. 13.09.08
193 Halometasone (as monohydrate ) 0.05% Cream  For the relief of inflammatory and pruritic manifestation of non-infected corticosteroid responsive dermatoses like eczema 13.09.08
194 Calcium and Magnesium 24% (Veterinary) injectable solution.  For the treatment of milk fever, hypocalcaemia tetanies and disorders of calcium metabolism in dairy cattle. 13.09.08
195 Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength) for the treatment of essential hypertension  15.09.08
196 Drotaverine + Aceclofenac (80mg + 100mg) Tablets For the treatment of adult patients with muscular pain associated with spasm 15.09.08
197 Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets For the treatment of mild to moderate hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy 15.09.08
198 Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength) for the treatment of essential hypertension  15.09.08
199 Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion For the treatment of seborrhoeic dermatitis 15.09.08
200 Citicoline CR Tab 1000mg For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia. 16.09.08
201 Montelukast Suspension 5mg/5ml 1. For the treatment of Prophylaxis & chronic treatment of Asthma in Pediatrics patients 12 months of age & older. 2. For relieving symptoms of seasonal allergic rhinitis in Pediatric patients 2 years of age & older & perennial allergic rhinitis in Pediatric Patients 6 months of age & older.  16.09.08
202 Etoricoxib roll on Topical Solution 1% v/v For the treatment of pain, swelling & inflammatory conditions due to arthritis. 16.09.08
203 Risedronate Sodium 150mg Tablet (Additional Strength) As already approved  16.09.08
204 Levosulpiride Inj. 25mg/ml, 2ml  For the treatment of depression and schizophrenia in adults when oral therapy is not possible 26.09.08
205 Paliperidone ER Tablet 3mg / 6mg / 9mg For the acute and maintenance treatment of schizophrenia 26.09.08
206 Ceftiofur Crystalline free acid Suspension equi to Ceftiofur ---- 200 mg(veterinary) For treatment of bovine respiratory disease (BRD, Shipping fever, pneumonia) associated with Mannhenia haemolytica, Pasteurella multocida, andHistophilus somni in beef, non-lactating dairy, and lactating dairy cattle 26.09.08
207 Ceftiofur HCl Suspension(as HCl salt) ----500mg (veterinary) For treatment of sub clinical mastitis in dairy cattle at the time of dry off asssociated with staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. 26.09.08
208 Ceftiofur HCl Suspension (as HCl salt) ----125mg (veterinary) For treatment of clinical mastitis in lactating dairy cattle asssociated with coagulase- negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. 26.09.08
209 Nitrofurantoin SR Tab. 100mg For the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus 26.09.08
210 Tolperisone HCl Tablet 50 / 100 / 150mg  For the relief of painful muscle spasms of the skeletal musculature 26.09.08
211 Etoricoxib + PCM (60mg + 500mg) Tablets  For the short term use in acute painful and inflammatory condition 30.09.08
212 Citicoline Oral Drops For the treatment of disturbance of consciousness resulting from head injuries, brain operation & acute stage of cerebral infraction in adult. 30.09.08
213 Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) Injection Indicated for the treatment of mastitis, metritis, pneumonia, pleuritis, fever and relieving of acute pain in musculoskeletal disorders in animals 30.09.08
214 Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets For the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing Children) 30.09.08
215 Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup for the treatment of chloroquine resistant/multidrug resitant on complicated malaria 30.09.08
216 Cabergoline 1mg Tablets (Additional indication) For the treatment of hyperprolactinemia and inhibition of lactation. 01.10.08
217 Pemetrexed disodium500mg / 100mg powder for sol. (Addl.indication ) In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology 08.10.08
218 Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary) For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment of diseases due to clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and treatment of ornithobacterium rhinotacheale (ORT) 08.10.08
219 Bortezomib inj.3.5mg/vial (Additional Indication) Treatment of patients with multiple myeloma 09.10.08
220 Sertaconazole Nitrate Vaginal Tab.500mg For the treatment of vulvo-vaginal candidiasis in women 09.10.08
221 Fosfomycin Tromethamine Sachet 3gms For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcus faecalis 09.10.08
222 Ixabepilone lyophilized powder (additional Indication) As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to cytotoxic chemotherapy. Previous therapy should have included as anthracycline, a taxane, and capecitabine 09.10.08
223 Eprosartan Mesylate 400 mg / 600mg Tablets For the treatment of essential hypertension 11.10.08
224 Tretinoine Gel as Micro Sphere 0.04% % 0.1% For topical treatment of Acne vulgaris. 14.10.08
225 Hydroxychloroquine Sulphate (Additional indication ) For the treatment of systemic lupus erythematosus 17.10.08
226 Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication) Indicated in the regular treatment of patients with moderate to severe COPD with frequent symptoms and a history of exacerbations 17.10.08
227 Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops For post operative steroid responsive inflammatory ocular condition when bacterial ocular infections or a risk of bacterial ocular infections exists. 21.10.08
228 Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules For the treatment of acute inflammation conditions associated with spasm in adults only 21.10.08
229 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel For the treatment of acne vulgaris 24.10.08
230 Aceclofenac Roll - On 1% For the treatment of acute musculoskeletal pain in patients 24.10.08
231 Citicoline Troches 200/500mg For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerative damages and chronic cerebral vascular injuries in senile dementia. 31.10.08
232 Amisulpride S.R.Bilayered tablet 200/400mg For acute and chronic schizophrenic disorders, in which positive symptoms and or negative symptoms are prominent, including patients characterised by predominant negative symptoms. 03.11.08
233 Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules For the treatment of hypocalcaemia and/or osteoporosis 04.11.08
234 Atazanavir + Ritonavir(300mg + 100mg) FC Tablets For the treatment of patients with HIV infection 04.11.08
235 Timolol Maleate SR Eye Drops 5.0mg / ml For the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma. 08.11.08
236 Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. Indication) 1) As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 2)As an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. 08.11.08
237 Paclitaxel inj.30/100/300mg vial (Addl. Indication) For the treatment of advanced gastric carcinoma 08.11.08
238 Montelucast + Desloratidine(10mg + 5mg) FC Tablets For the treatment of allergic rhinitis in adults only 10.11.08
239 Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets Additional Lower Strength 10.11.08
240 Losartan + HCTZ (100 mg + 25 mg) Tablets Additional Strength 10.11.08
241 Phenyramidol HCl tablet 400mg For the treatment of lumbago, integumental pain, musculoskeletal pain 14.11.08
242 Salicylic Acid + Coal Tar (3% + 1%) Solution For scaling of seborrhea, seborrheic dermatitis, psoriasis of scalp 17.11.08
243 Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment For the treatment of psoriasis and fungal skin infection 17.11.08
244 Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets For the acute treatment of inflammatory musculoskeletal disorders associated with painful muscle spasm in adults. 17.11.08
245 Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) Capsules Additional Lower Strength 17.11.08
246 Calcium Hypochlorite 4gm Sachet (Calcium Hypochlorite 0.542% Other Ingredients: 99.458%) For purification of contaminated ground water sources. 23.11.08
247 Sumatriptan + Naproxen (50mg + 275mg) Tablets Additional Lower Strength 24.11.08
248 Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC Tablets For the treatment and management of patients with community acquired pneumonia or acute bacterial sinusitis due to beta lactamase producing pathogens 25.11.08
249 Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets Additional Lower Strength 02.12.08
250 Atorvastatin + Metformin(10mg + 500mg SR) Tablets As adjunctive therapy to diet and exercise in patients with diabetic dyslipidemia 04.12.08
251 Pemetrexed disodium 500mg / 100mg powder for sol. (Addl. Indication) As monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology 04.12.08
252 Magnesuim Valproate Tablet 200mg/400mg For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. For the treatment of maniac episodes associated with bipolar disorders. For prophylaxis of migraine headache in adults. 04.12.08
253 Ursodeoxycholic Acid 300/600 SR Tablets (Additional Strength) For the dissolution of Radiolucent collestral goll stone, chronic cholestatic liver disease in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cyatic fibrosis. 08.12.08
254 Rifampicin + INH + Piperine (200mg + 300mg + 10mg ) Capsules For the treatment of adult patients with pulmonary tuberculosis 11.12.08
255 Rifampicin +Piperine (200mg + 10mg ) Capsules For the treatment of adult patients with pulmonary tuberculosis 11.12.08
256 Amphotericin B Lipid suspension 50mg/ vial (Addl. Strength) Additional Strength 12.12.08
257 Desmopressin Acetate tablet 0.1/0.2 mg For the treatment of cranial diabetes insipidus , primary noctumal enuresis in patients. 12.12.08
258 Mifepristone + Misoprostol (1 tab of mifepristone 200mg and 4 tab of misoprostol 200mcg) Combipack For the medical termination of intrauterine pregnancy (MTP) of up to 63 days gestation based on the first day of the last menstrual period 16.12.08
259 Lamotrigine MR Tablets 50/100mg For the treatment of bipolar I disorder. (addl. Indication) 17.12.08
260 Levosulpride Injection 25mg/2ml (Additional Strength) For the treatment of different Gastro intestinal problems like functional dyspepsia, nausea, vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults. 17.12.08
261 Cyclobenzaprine HCl ER Capsule 15/30mg As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions. 17.12.08
262 Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml (Additional Indication ) In combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. 17.12.08
263 Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion For the treatment of scaly dermatoses 18.12.08
264 Azathioprine 25mg Tablets Additional Strength 19.12.08
265 Paracetamol solution for infusion 10mg/ml For short term treatment of moderate pain, especially following surgery and for the short term treatment of fever, when administration by i.v route is clinically justified 23.12.08
266 Gemifloxacin + Ambroxol (320mg + 75mg SR) FC Tablets Indicated for the treatment of lower respiratory tract infections in adult patients 24.12.08
267 Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection 1. For LRTI infections, 2. for UTI - Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic infections including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis 24.12.08
268 Paracetamol + Phenylephrine Hydrochloride (Each 6gm Sachet contains: 500mg + 10mg) Sachet For the treatment of fever associated with cold, nasal congestion in adults 24.12.08
269 Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrup For symptomatic treatment of cough 24.12.08
270 Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules Additional Lower Strength 24.12.08