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Home , Temoporfin, Valproate

LIST OF APPROVED DRUG FROM 01.01.08 TO 31.12.08

S. Approval Drug Name Indication No. Date For temporary relief from Me-salicylate 30% + 10% + camphor 4% pain, swelling & 1 29.11.07 Cream inflammation due to musculoskeletal disorder For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic 2 Voglibose 0.2mg/0.3mg tablet (Mouth dissolving) 28.12.07 drug or insulin preparation in addition to diet and or exercise do not result in adequate glycemic control. Hydroxychloroquine 400mg tablets (Additional 3 Same as Approved 31.01.08 Strength)

ISMN 30mg SR + Metoprolol Succinate equivalent 4 to metoprolol tartrate 25mg/50mg tablets Same as Approved 02.01.08 (Additional Strength)

For the treatment of responsive fungal 5 Halobetasol 0.05% + 1.0% cream 04.01.08 infections including eczema and psoriasis For the treatment of disturbance of consciousness resulting 6 Citicholine Syrup 750mg/5ml from head injuries, brain 04.01.08 operation and acute stage of cerebral infarction in adults only

7 Levodopa 200mg + Carbidopa 50mg C.R. tablet For Parkinson's Disease 08.01.08

For the treatment of burns 8 Nanocrystalline Silver Gel 0.002% 04.01.08 and wound infections For the treatment of 9 Cinitapride (as hydrogen tartrate) 1mg tablet 04.01.08 gastroesophageal reflux disease and functional inconveniences of the gastrointestinal motility For the treatment of adult Tenofovir disoproxil fumarate 300mg + 10 patients with HIV 07.01.08 Lamivudine 300mg tablet infection For the treatment of Urinary tract infections, respiratory tract Cefixime 200mg/100mg + Lactic bacillus 2.5 11 infections, biliary tract 07.01.08 billion spores tablet & dispersible tablet infections in adult patients prone to antibiotic associated diarrhoea D-Trans Metrix system (12mcg/hr.) 12 Same as Approved 07.01.08 (Additional Strength) For the treatment of lower Ceftazidime 500mg + Tobramycin 60mg per vial respiratory tract infection 13 08.01.08 (Injection) caused by pseudomonas aeruginosa

14 Atazanavir 300mg capsules (Additional strength) Same as approved 08.01.08

For the prophylaxis of for injection 1gm/vial (additional surgical site infections 15 15.01.08 indication) following elective colorectal surgery As an adjunct to diet and exercise to improve 16 Vildagliptin Tablets 50mg/100mg glycemic control in 18.01.08 patients with type-II diabetes mellitus For the treatment of dyslipidemia associated with atherosclerotic 17 Atorvastatin 10mg + 75/150mg Capsules arterial disease with risk 18.01.08 of myocardial infarction, stroke or peripheral vascular disease

Smatriptan (as succinate ) 50mg + Naproxen For the treatment of acute 18 22.01.08 sodium 550mg tablets Sodium 666mg + valproic acid 290mg 19 equivalent as sodium valproate 1000mg C.R. tablet Same as Approved 24.01.08 (Additional Strength)

For serious CRTI, uncomplicated and complicated UTI, Cefepime (as hydrochloride) 2000/1000/500mg + Uncomplicated skin & 20 Sulbactam (as sodium) 1000/500/250mg per vial of 24.01.08 skin structure, infection injection acute exacerbation of chronic bronchitis & intraabdominal infection. Ovarian , non-small Nanoparticle Solution for Injection 21 cell and AIDS 22.01.08 20mg/ml (Additional indication) related Kaposis Sarcoma For hepatocellular 22 Sorafenib tablets 200mg (Additional Indication) 22.01.08 Carcenoma For prophylaxes and treatment of both Zanamavir inhalation powder 5mg/blister 23 influenza A & B in adults 22.01.08 (Additional Indication) and children (greater than or equal to 5 years) For the prophylaxis of acute organ rejection in Mycophenolate Mofetil Capsule 250mg, 500mg & 24 patients receiving 23.01.08 Oral suspension 200mg/ml (Additional Indication) allogeneic hepatic transplantation

Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each For the treatment of 25 + 24 tablets of carbonate 1250mg osteoporosis in post- 23.01.08 (equivalent to 500mg Calcium) + cholecalciferol- menopausal women 250IU

For short term treatment of pain due to post 26 Aceclofenac injection 150mg/ml 23.01.08 operative and post traumatic cases For the treatment of Atorvastatin 10mg + Fenofibrate 80mg tablet 27 combined hyperlipidemia 25.01.08 (Additional Indication) in patients with normal hepatic and renal functions.

Sodium Valproate 499.5mg + Valproic acid 28 217.5mg equivalent as sodium valproate- 750mg Same as Approved 24.01.08 CR tablet (Additional Strength)

Diclofenac 50mg + Serratiopeptidase 10mg enteric For the treatment of acute 29 24.01.08 coated tablet pain in adults

Gabapentin 100mg + methylcobalamin 500mcg 30 Same as Approved 24.01.08 tablets (Additional Strength)

For the treatment of infection caused by Cefpirome (as sulphate) 500/1000mg/2000mg + sensitive organisms viz. 31 Sulbactam (as sodium ) 250mg/500mg/1000mg 24.01.08 lower RTI, complicated powder for injection UTI, Septicemia, bacteremia For the treatment of Type- Metformin HCl ER 500mg + Fenofibrate 32 II diabetes associated with 25.01.08 80mg/160mg tablet mixed dyslipidemia Salicylic acid 10mg/20mg (Foaming facewash For the treatment of acne 33 28.01.08 solution) vulgaris For the treatment of 34 Ozagrel Hcl. Tablets 100mg/200mg 28.01.08 bronchial asthma For the treatment of patients with mild to Rivastigmine transdermal patch (each patch of 5m2, moderately severe 35 10m2,15m2 & 20m2 contain Rivastigmine base dementia of the Alzheimer 28.01.08 9/18/27/36mg respectively type and dementia associated with Parkinsons disease For the treatment of complicated skin and skin Daptomycin powder for concentrate for solution for structure infections and 36 28.01.08 infusion (350mg/500mg per vial) for staphylococus aureus bloodstream infections (bacteremia) For the relief of persistent Orodispersible strip 37 dry irritating cough in 28.01.08 5.5mg/11mg adult patients only

Diclofenac sodium 50mg + Dicyclomine HCl 20mg For the treatment of acute 38 28.01.08 per ml of injection colicky pain in adults

For decrease of intraocular pressure in patients with open angle glaucoma or Travoprost 40mcg + Timolol (as Maleate) 5mg per ocular hypertension, who 39 28.01.08 ml of eye drops are insufficiently responsive to topical beta blockers or prostaglandin analogues For RTI, SRS of tissue infection, bons & joint Amoxicillin 250mg/125mg + Cloxacillin infection, ENT infection 40 250mg/125mg + Lactic Acid Bacillus 1.7 Billion 30.01.08 in adults prone to spores antibiotic associated diarrhoea For RTI, SRS of tissue infection, bons & joint Amoxicillin 250mg + Lacto- Bacillus 1.7 billion infection, ENT infection 41 31.01.08 Spores in adults prone to antibiotic associated diarrhoea

Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calcium For Vitamins and Pantothenate25mg+Folic Acid 1.5mg+ 42 Minerals deficiency states 30.01.08 oxide22.5mg+Chromium in adult patients picolinate65mcg+Inositol10mcg+Lutein5mg capsule

Methylcobalamine 750mcg + Alphalipoic acid For Vitamins and 100mg + Benfothiamine 7.5mg + B6 1.5mg + 43 Minerals deficiency states 30.01.08 Calcium pantothenate25mg + 50mg + in adult patients Folic acid0.75mg capsule Mecobalamin500mcg + Alpha Lipoic Acid200mg + For Vitamins deficiency 44 Benfotiamin 10mg + Pyridoxine3mg + Biotin5mg + 30.01.08 states in adult patients Folic acid 1.5mg capsule

For the treatment of lower RTI, skin & soft tissue Amoxycillin 250mg + Cloxacillin 250mg + bone & joint infections, 45 30.01.08 Lactobacillus 2 billion spores capsules ENT infections in adult patients prone to antibiotic associated diarrhoea As 3rd line treatment of sever cases of COPD Tiotropium (as Tiotropium Monohydrate) when monotherapy and 46 18mcg + Formoterol Fumarate Dihydro. 12mcg + 31.01.08 second line therapy with Ciclesomide 400mcg per capsules two drugs do not respond adequately For the treatment of Metoprolol Succinate Equivalent to Metoprolol patient with both essential 47 Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 28.01.08 hypertension and 10mg tablets hypercholesterolemia

Levocetrizine Di HCl Dispersible tablet 5mg/10mg For allergic rhinitis & 48 28.01.08 (New Dosage form) chronic urticaria

Oseltamivir 30mg & 45mg Capsules (Additional 49 Same as Approved 28.01.08 Strength) Treatment of acute Fondaparinax Sodium injection (Additional coronary syndrome (ACS) 50 28.01.08 Indication) with and without ST- segment elevation For remission of acute symptoms of chronic 51 Camostat Mesylate tablets 100mg and post- 29.01.08 operative reflux esophagitis For intradermal Hyaluronic Acid Salt 25mg + Cross-Linked 52 implantation and facial 30.01.08 Hyaluronic acid 25mg per ml in prefilledsyringe soft tissue agumentation For the treatment of 53 Ursodeoxycholic acid tablets 600mg patients with chronic 30.01.08 cholestatic disease For the extended treatment of symptomatic venous thromboembolism (VTE) proximal deep 54 Dalteparin Sodium Injection(Additional Indication) thrombosis (DVT) and/or 30.01.08 pulmonary embolism (PE), to reduce the recurrence of VTE in patients with cancer For the topical treatment Beclomethasone Dipropionate 0.25mg + Econazole 55 of bacterial and fungal 30.01.08 10mg + Neomycin 5mg per gm of Cream infections For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who Exenatide injection (Each 2ml vial contains- have not achieved 56 Exenatide 5mcg/10mcg per 0.2ml ) (Additional 30.01.08 adequate glycemic control Strength) with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas For the symptomatic treatment of acute pain and inflammation in Diclofenac Sodium 50mg + Paracetamol 500mg 57 patients with 30.01.08 tablets osteoarthritis, rheumatoid arthritis and ankylosing spondylitis As adjunctive therapy in 58 SR 600mg tablets the treatment of partial 30.01.08 seizures of For moderate to severe 59 Memantine 5mg /10mg + Donepezil 5mg Tablets 31.01.08 Alzheimer's disease For carcinoma of the stomach, colon, rectum, 60 Capsules 100mg/200mg 31.01.08 breast, uterine, cervix and bladder Haemodialysis Powder/Liquid Form containing For use for patients being 61 31.01.08 citrate treated by hemodialysis 1:- In newly diagnosed high-grade malignant glioma patients as an (polifeprosan 20 with carmustine adjunct to surgery and 62 31.01.08 Implant (Wafer) radiation. 2:- In recurrent multiforme patients as an adjunct to surgery For the treatment of 63 Cimetropium Bromide tablet 50mg 31.01.08 irritable bowel syndrome As adjunct to rest and physical therapy for relief of muscle spasm 64 CyclobenzaprineHcl. Tablets 5mg/10mg 31.01.08 associated with acute painful musculoskeletal conditions For the topical treatment 65 Sertaconazole Nitrate Cream 2%, of the superficial mycosis 31.01.08 like dermatophytosis

Cefpodoxime 50mg + Clavulanic acid 31.25mg 66 Same as Approved 31.01.08 dispersible tablet & dry syrup (Additional strength)

For the treatment of overactive bladder with (as hydrobromide) 7.5mg/15mg ER 67 symptoms of urge urinary 31.01.08 tablets incontinence, urgency and frequency For the treatment of respiratory tract infection, Amoxycillin 125mg/250mg/500mg + Lactobacillus skin and soft tissue 68 31.01.08 1.66 billion Spores (Capsules) infections & antibiotics associated diarrhoea in adult patients For steroid responsive Halobetasol 0.5mg + Miconazole 20mg per gram dermatoses associated 69 31.01.08 Cream with superficial fungal infection of skin For the treatment of Montelucast 10mg + Levocetirizine 5mg film 70 allergic rhinitis in adults 31.01.08 coated tablets only For short term intermittent treatment of moderate to severe melasma of the Hydroquinone 2% + 0.025% (w/w) 71 face in the presence of 31.01.08 Momentasone 0.10% Gel measures for sun avoidance including use of sun screen

Phenylephrine 5mg + Chlorpheniramine maleate For the treatment of 72 0.5mg + Paracetamol 125mg + sodium citrate 60mg common cold and cough 31.01.08 + Menthol 1mg (per 5ml) Syrup associated with fever

For treatment of painful Diclofenac Sodium 100mg (SR Pellets) + inflammatory conditions 73 31.01.08 Rabeprazole Sodium 20mg (E.C Pellets) Capsules associated with gastroduodenal ulcers As third line treatment of severe cases of COPD, Ciclesonide 160mcg/320mcg/Formoterol 12mcg + when monotherapy and 74 31.01.08 Tiotropium 18mcg Dry powder inhaler second line therapy with two drugs do not respond adequately VSL # (Combination of lactic acid bacteria (VSL # For the treatment of 75 31.01.08 3) irritable bowel syndrome For the treatment of serious infection caused Gram-Ve bacteria including LRTI, UTI, 76 Clostimethate Sodium of 1,00,000IU Injection 31.01.08 where commonly used anti bacterial agent may be infective because of bacterial resistance Ramipril 5mg + HCTZ 12.5mg tablets (Additional 77 Same as Approved 20.02.08 Strength) For the treatment of amoebiasis, urogenital 78 Metronidazole CR tablet 600mg 21.02.08 trichomoniasis & giardiasis for the additional indication "acute manic 79 fumarate SR tablets 21.02.08 episode associated with additional Strength (it should not be used routinely because of increased risk of adverse Atorvastatin Calcium 80mg tablets (Additional 80 events. It should be 25.02.08 Strength) reserved for patients who are considered to be at higher risk after careful risk assessment

Euphorbia Prostrata Dry Extract (ethanolic 80% For the treatment of 81 29.02.08 (v/v) (35-70) :100mg tablet haemorrhoid

For the treatment of 82 Amtolmetin Guacil tablets 600mg osteoarthritis & 07.03.08 rheumatoid arthritis For lowering of IOP in Brimonidine Tartrate Opthalmic solution 0.1% patients with open angle 83 (with purite as preservation 0.005%) (additional 07.03.08 glaucoma occular strength) hypertension 1:- For repigmentation of idiopathic vitiligo alongwith phototherapy. 2:- For symptomatic 84 Methoxsalen USP-20mg Tablet 07.03.08 control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy Cefditoren pivoxil 400mg tablets (Additional 85 Same as Approved 11.03.08 Strength) For the treatment of Doxofylline ER tablets 400mg/800mg (addl. 86 bronchial asthma & 12.03.08 Strength) COPD in adults For the treatment of steroid responsive 87 Betamethasone 0.05% +Miconazole 2% Cream dermatoses associated 12.03.08 with superficial fungal infections of the skin Premetrxed disodium injection 100mg/vial 88 Same as Approved 12.03.08 (Additional Strength) 20mg/40mg + Sodium bicarbonate For gastric ulcer, duodenal 89 12.03.08 1680mg per sachet powder for oral suspension ulcer, and GERD

Mecobalamin 1000mcg+ Alpha For the treatment of 90 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ 19.03.08 Inositol 100mg + Benfotiamine 100mg capsule

ISMN 30mg SR + Atenolol 50mg tablets 91 Same as Approved 19.03.08 (Additional Strength)

Temozolamide capsules 140mg/180mg (Addl. 92 Same as Approved 31.03.08 Strength)

93 Amisulpiride 300mg tablets (Additional Strength) Same as Approved 20.03.08

For the treatment of 94 SR Tablets 10mg/20mg 24.03.08 essential hypertension

For symptomatic relief of Ambroxol HCl. 15mg + Guiphenesin 50mg + bronchospasm in 95 Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 26.03.08 bronchial asthma and ml of syrup chronic bronchitis

For the symptomatic relief Ambroxol HCl 30mg + Guaiphenesin 100mg + of bronchospasm in 96 26.03.08 Terbutaline sulphate 2.5mg per 10ml Syrup bronchial asthma & chronic bronchitis

For the treatment of mild 97 Boswellia Serrata 0.05gm/gm of Cream 28.03.08 to moderate psoriasis For short term use in acute 98 Etoricoxib injection 90mg/ml painful condition in adults 28.03.08 only

Drospirenone 3mg + Ethinyl 0.02mg Oral contraceptive in 99 28.03.08 tablets (Additional Strength) women

For symptomatic 100mg ER + Levocetirizine HCl 5mg 100 treatment of acute 28.03.08 Tablets rhinosinusitis For the treatment of mild to moderate pain, such as Dexketoprofen (as Trometamol ) tablets 101 dental pain, 28.03.08 12.5mg/25mg dysmenorrhoea & musculoskeletal pain For the treatment of pain and inflammation 102 Nepafenac Opthalmic suspension (1mg/ml) 31.03.08 associated with cataract surgery For pain management in Hylan GF 20 Injection (Synvisc) (Additional patients suffering with 103 31.03.08 Indication) osteoarthritis of the knee, hip, shoulder and ankle For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell 104 injection conc. carcinoma of head & 31.03.08 neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic

Methylcobalamin 1000mcg + Pyridoxine Hcl IP 105 100mg + Nicotinamide IP 100mg + D-Panthenol IP For 31.03.08 50mg per 2 ml of injection

Lamivudine 20mg + Stavudine 5mg dispersible 106 Same as Approved 01.04.08 tablets (Additional Sgtrength)

For short-term treatment of hypertension when oral 107 Hcl. Injection 2.5mg/ml 07.04.08 therapy is not feasible or not desirable

Diclofenac Potassium 50mg + Serratiopeptidase (as For the treatment of acute 108 enteric coated pellets) 15mg capsules (Additional 08.04.08 pain in adults Strength)

For the treatment of adult 109 Diacerin 50mg + Aceclofenac 100mg tablets patients with osteoarthritis 11.04.08 of knee and or hip joints Rabeprazole sodium Enteric coated pellets 15.4% 110 Same as Approved 16.04.08 w/w (20mg/129.83mg)

Live freeze-dried lactic acid bacteria and For the treatment of 111 10.04.08 bifidobacteria capsules irritable bowel syndrome

Miltefosin Capsule 10mg/50mg (Additional Treatment of cutaneous 112 16.04.08 Indication) leishmaniasis As an antimicrobial barrier for management of partial thickness burns, incisions, skin grafts, 113 Silver Wound Dressing donor sites, lacerations, 16.04.08 abrasions and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic) For the treatment of adult Diacerin 50mg + Glucosamine sulphate 500mg 114 patients with osteoarthritis 21.04.08 tablets. of knee and hip joints For focal spasticity, including the treatment of Clostridium Botulinum type-A toxin arm symptoms associated 115 22.04.08 haemagglutinin complex (Additional Indication) with focal spasticity in conjunction with physiotherapy For the treatment of systemic candidiasis, mucosal candidiasis, 116 Fluconazole Dispersible tablets 50mg 22.04.08 prevention of fungal infections in patients with malignancy In combination with for the Lenalidomide Capsule 5mg/10mg/15mg/25mg treatment of multiple 117 22.04.08 (Additional Indication) myeloma patients who have received at least one prior therapy

As an adjunct to diet & Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 118 exercise to improve 28.04.08 500mg/1000mg Film coated tablets glycemic control in patients with type-two diabetes mellitus

For short term treatment of errosive esophagitis 119 Lansoprazole for injection 30mg/vial when patients are unable 28.04.08 to take the oral formulation For the treatment of RA in 120 Naproxen Suspension 125mg/5ml children 5 years of age 28.04.08 and above For control of serum Sevelamer Carbonate 400mg/800mg tablets & phosphorus in patients 121 28.04.08 sachet 400mg/800mg with chronic kidney disease on dialysis For the treatment of Rabeprazole Sodium (With Sodium bicarbonate as gastric ulcer, duodenal 122 28.04.08 buffer) 10mg/20mg tablets ulcer, Zollinger Ellison Syndrome and GERD For the treatment of Pantoprazole Sodium (With Sodium bicarbonate as gastric ulcer, duodenal 123 28.04.08 buffer) 20mg/40mg tablets ulcer, Zollinger Ellison Syndrome and GERD For the treatment of community acquired pneumonia, acute Cefdinir 250mg dispersible tablets & oral exacerabation of chronic 124 29.04.08 suspension 250mg/5ml bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis management of 125 capsules (Addl. Indication) 29.04.08 fibromyalgia syndrome

Pregabalin 75mg/150mg + Methylcobalamin 126 Same as Approved 08.05.08 750mcg capsules (Additional Strength)

For the treatment of Aliskiren 150/150/300/300mg + HCTZ essential hypertension in 127 08.05.08 12.5/25/12.5/25mg tablets adult patients whose blood pressure is not adequately controlled on monotherapy .

Desmoprission lyophilisate Oral tablets For diabetes insipidus and 128 08.05.08 60mcg/120mcg/240mcg per tablets noctural emuresis

Losartan Potassium 25mcg + (as 129 Same as Approved 14.05.08 besylate) 5mg tablets. (Additional Strength)

For alcoholic liver Lecithin Liquid (each 5 ml contains lecithin 500mg 130 disease, drug induced 14.05.08 equivalent to essential phospholipids 250mg

Halobetasol 0.05% + Salicylic acid 6% Ointment For the treatment of 131 14.05.08 (additional Strength) plaque psoriasis

Benzoyl Peroxide Medicated Solution (each For the topical treatment 132 14.05.08 textured pad contains 4.5%/6.5%/8.5% of solution of acne vulgaris

133 Deflazocort 24mg tablets (Additional strength) Same as Approved 14.05.08

For use as a surgical aid in Sodium Chondroitin sulfate 40mg + sodium anterior segments 134 Hyaluronate 30mg per ml Intraocular Injection procedure including 14.05.08 (additional strength) catract extraction & intra- ocular lens implantation For the treatment of Esomeprazole (with Sodium bicarbonate as buffer) GERD, gastric and 135 14.05.08 20mg/40mg tablets duodenal ulcer, Zollinger- Ellison syndrome For coexisting essential 40 mg + Atorvastatin (as calcium) 10 136 hypertension & 22.05.08 mg Tablets hyperlipidemia For the treatment of adult Milnacipran Hcl. 25mg/50mg equivalent to 137 patients with major 22.05.08 Milnacipran free base 21.77 or 43.55 mg. tablet. depressive disorder Metolazone 2.5mg + Losartan Potassium For hypertension in 138 28.05.08 25mg/50mg tablets patients whose blood pressure is not adequately controlled in monotherapy For essential hypertension in adult patients whose 139 Metolazone 2.5mg + Ramipril 2.5mg/5mg blood pressure is not 28.05.08 adequately controlled on monotherapy For the treatment of secondary Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin 140 hyperthyroidism in 29.05.08 capsules patients with chronic kidney disease on dialysis For the treatment of adult patients with chronic 141 Acebrophylline capsules 100mg obstructive pulmonary 29.05.08 disease and bronchial asthma For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, 142 Sofalcone Capsule (100mg/50mg) hemorrhage, redness or 02.06.08 edema) associated with acute gastritis or acute exacerbation of chronic gastritis For the relief of pain and inflammation in patients 143 S(+) Etodolac ER tablets 200mg/300mg 02.06.08 with rheumatoid arthritis and osteoarthritis For the treatment of adult Diclofenac Sodium 50mg + Codeine Phosphate patients with signs & 144 02.06.08 50mg tablets symptoms of acute painful conditions

Sodium Hyaluronate injectable gel (each 0.6ml. 1ml For intradermal 145 pre filled syringe contains, sodium Hyaluronate implantation and facial 03.06.08 20mg/ml, 22.5mg/ml soft tissue augmentation

For invasive fungal Amphotericin B Lipid suspension injection 146 infection in patients who 03.06.08 (25mg/vial) with lipid suspension are refractory to or intolerant of conventional amphotericin B therapy

For the treatment of Gastroeasophageal Reflux Dexrabeprazole 10mg (EC) + 30mg 147 Disease (GERD) in 09.06.08 SR Capsules patients not responding to dexrabeprazole alone For acute low back pain & Thiocolchicoside 4mg/8mg + Ketoprofen other musculoskeletal 148 11.06.08 50mg/100mg tablets painful and inflammatory condition in adults For the treatment of lower Cefotaxime sodium + Sulbactam sodium for 149 respiratory tract infection 24.06.08 injection (Additional Indication) in children

Artemether 40mg/80mg + Lumefantrine 150 Same as Approved 24.06.08 240mg/480mg tablets (additional Strength)

Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg+ For the treatment of 151 03.07.08 Benfotiamin100mg + Pyridoxine 50mg tablets diabetic Neuropathy

For the treatment of chronic stable anginapectoris in patients with normal sinus rhythm 152 Ivabradine (Hcl.) 5mg/7.5mg Tablets 03.07.08 who have a contraindication or intolerance for Beta- blockers

Methylcobalamin 1500mcg + Alpha Lipoic Acid For the treatment of 153 200mg + Benfotiamine 50mg + Vit B6 3mg + 04.07.08 diabetic Neuropathy Biotin 5mg + Folic Acid 1.5mg capsule

Indicated to meet daily requirement of nitrogen Amino Acid, Glucose Parentral Solution (Solution (amino ), energy 154 08.07.08 for intravenous infusion) (glucose) for patients needing parentral Nutrition 155 Temoporfin 1mg/ml Injection (Additional Strength) Same as Approved 08.07.08

For the treatment of RTI, Pazufloxacin Mesylate i.v. infusion 300mg/100ml 156 UTI and abdominal 09.07.08 & 500mg/100ml infections in adults For coronary artery Metoprolol ER + Amlodipine tablets (Additional 157 disease/ischaemic lheartt 16.07.08 Indication) disease

Fenofovir Disoproxil fumarate 300mg + 158 18.07.08 Lamivudine 300mg + 600mg tablets

For the treatment of type_II diabetes mellitus Vildagliptin 50mg/50mg/50mg + Metformin Hcl when single drug therapy 159 21.07.08 500mg +850mg +1000mg tablets alongwith diet, exercise do not result in adequate glycemic control For replacement therapy of male hypogonadism when 160 250mg/ml Injection testosterone dificiency has 22.07.08 been confirmed by clinical feature or biochemical tests For adult patients with severe active rheumatoid arthritis who had an 161 Abatacept powder for injection 250mg/vial inadequate response to 22.07.08 one more DMARDs such as methotixate or TNF antagonists For the treatment of 162 Actarit 100mg Tablets rheumatoid arthritis 22.07.08 patients

Tenofovir Fumarate 300mg + Lamivudine 300mg + For the treatment of HIV 163 23.07.08 Efavirenz 600mg Tablets infection in adults

Bacillus Clausii Spores (2 Billion) Capsules 164 Same as Approved 23.07.08 (additional dosage form) For reduction of part Gatifloxacin 0.3% + Tramthamine 0.4% 165 operative inflammatory 24.07.08 eye Drop condition of eyes For the reduction of post Ketorolac Tromethamine 4mg + Gatifloxacin 3mg 166 operative inflammatory 24.07.08 Eye Drops conditions of the eye

Cefadroxyl (as monohydrate) 125mg + Clavulanic 167 acid (as potassium) 31.25 per 5ml Syrup Same as Approved 25.07.08 (Additional strength)

For the treatment of secondary Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule hyperparathyroidism in 168 05.08.08 (Additional Indication) patients with stage 3 or stage 4 chronic kidney disease

Artemether + Lumefantrine Dispersible tablet 169 Same as approved 05.08.08 (40/80mg + 240/480mg ) (Additional Strength)

Ceftazidime + Tobramycin injection (1gm + 170 Same as approved 05.08.08 120mg) (Additional Strength)

For the relief of the symptoms of seasonal 171 Olopatadine Nasal Spray (0.6%) 05.08.08 allergic rhinitis in patients 12 years of age and older For the symptomatic treatment of pain and 172 Loxoprofen Sodium tablet (60mg) 14.08.08 inflammation condition in patients with osteoarthritis For the treatment of mild 173 Dexibuprofen Suspension 50mg/5ml to moderate pain, 14.08.08 reduction of fever For the treatment of postoperative inflammation & reduction 174 Bromfenac Sodium Eye Drop (0.09%) of postoperative ocular 14.08.08 pain in patients who have undergone cataract extraction for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic Ceftriaxone + Sulbactam injection (Additional 175 inflammatory disease, 18.08.08 Indication) bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis For the treatment of disturbance of consciousness as resulting 176 Citicoline Chewable tablet (500mg) from head injuries , brain 18.08.08 operation and acute stage of cerebral infraction in adult only

Ambroxol + + Guaifenesin Syrup (30mg For the treatment of 177 18.08.08 + 5mg + 50mg per 5ml) productive cough

Ferrous Ascorbate + Folic Acid + Zinc FC Tablets For the treatment of iron 178 18.08.08 (100mg + 1.5 mg + 22.5 mg) deficiency anaemia

Cyclobenzaprine 7.5mg tablets (Additional 179 Same as approved 18.08.08 Strength) For the treatment of haemo-dynamically stably S-Metoprolol Succinate Oral Solution (Each Ml patients with definite or 180 contains: S-Metoprolol Succinate 9.5mg equal to S- suspected acute 19.08.08 Metoprolol Tartrate 10mg) Myocardial Infarction to reduce cardio-vascular mortality. In combination with bortezumab for the treatment of progressive multiple myeloma in HCl Pegylated Liposomal Injection patients who have 181 23.08.08 (20/50MG) (Additional Indication) received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant As mouthwash for oral Povidone Iodine Sachet (containing Effervescent hygeine in various 182 Granules) Each 2gm Sachet contains: 175mg oropharyngeal conditions, 25.08.08 (available iodine 17.5mg) surgery, dental infections, and halitosis

Sodium Chondroitin Sulphate + Sodium 183 Hyaluronate injection (40mg + not more than 17mg Same as approved 25.08.08 per ml)

For the treatment of oedema associated with Metolazone + FC Tablets (2.5/5mg 184 congestive heart failure, 25.08.08 + 50mg) cirrhosis and nephritic syndrome For topical treatment of 185 Tretinoin Microsphere Gel (0.1% W/V) 26.08.08 acne vulgaris

186 Misoprostol 50Mcg tablet (Additional Strength) Same as approved 26.08.08

Ferrous Ascorbate + Folic Acid Suspension (Equiv. 187 to elemental iron 30mg + 550mcg per 5ml) (New Same as approved 27.08.08 Dosage Form)

For the treatment of 188 Guaiphenesin ER Tablet (600mg) productive cough 28.08.08 accompanied by phlegm

189 Clopidogrel 300mg Tablet (addl. Strength) As approved 02.09.08

For the treatment of 190 150/500mg Tablets (addl. Indication) patients with metastatic 02.09.08 colorectal cancer For the treatment of Lopinavir + (100 + 25mg) Tablets 191 patients with HIV 08.09.08 (additional strength) infection in combination with capecitabine for the treatment of patients with lyophilized powder inj. 15mg/45mg per 192 metastatic or locally 13.09.08 vial advanced breast cancer resistant to treatment with an and a , or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. For the relief of inflammatory and pruritic manifestation of non- 193 Halometasone (as monohydrate ) 0.05% Cream 13.09.08 infected corticosteroid responsive dermatoses like eczema For the treatment of milk fever, hypocalcaemia Calcium and 24% (Veterinary) 194 tetanies and disorders of 13.09.08 injectable solution. calcium in dairy cattle.

Telmisartan + Ramipril (40mg + 2.5mg ) Tablets for the treatment of 195 15.09.08 (Additional Strength) essential hypertension

For the treatment of adult Drotaverine + Aceclofenac (80mg + 100mg) patients with muscular 196 15.09.08 Tablets pain associated with spasm For the treatment of mild to moderate hypertension Losartan + Chlorthalidone (25/25/50/50mg + in adult patients whose 197 15.09.08 6.25/12.5/6.25/12.5mg) Tablets blood pressure is not adequately controlled by monotherapy

Olmesartan + Ramipril (40mg + 5mg) tablets for the treatment of 198 15.09.08 (Additional Strength) essential hypertension

Fluconazole + Zinc Pyrethrone (Each 30/60ml For the treatment of 199 15.09.08 bottle contains: 2% + 1%) Lotion seborrhoeic dermatitis

For the treatment of patients with serious cerebral injuries of 200 Citicoline CR Tab 1000mg vascular traumatic nature 16.09.08 with or without loss of consciousness & for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia.

1. For the treatment of Prophylaxis & chronic treatment of Asthma in Pediatrics patients 12 months of age & older. 2. For relieving symptoms of 201 Montelukast Suspension 5mg/5ml 16.09.08 seasonal allergic rhinitis in Pediatric patients 2 years of age & older & perennial allergic rhinitis in Pediatric Patients 6 months of age & older. For the treatment of pain, 202 Etoricoxib roll on Topical Solution 1% v/v swelling & inflammatory 16.09.08 conditions due to arthritis. Risedronate Sodium 150mg Tablet (Additional 203 As already approved 16.09.08 Strength) For the treatment of depression and 204 Inj. 25mg/ml, 2ml in adults 26.09.08 when oral therapy is not possible For the acute and 205 ER Tablet 3mg / 6mg / 9mg maintenance treatment of 26.09.08 schizophrenia For treatment of bovine respiratory disease (BRD, Shipping fever, pneumonia) associated Ceftiofur Crystalline free acid Suspension equi to with Mannhenia 206 26.09.08 Ceftiofur ---- 200 mg(veterinary) haemolytica, Pasteurella multocida, andHistophilus somni in beef, non- lactating dairy, and lactating dairy cattle For treatment of sub Ceftiofur HCl Suspension(as HCl salt) ----500mg clinical mastitis in dairy 207 26.09.08 (veterinary) cattle at the time of dry off asssociated with staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. For treatment of clinical mastitis in lactating dairy cattle asssociated with Ceftiofur HCl Suspension (as HCl salt) ----125mg coagulase- negative 208 26.09.08 (veterinary) staphylococci, Streptococcus dysgalactiae, and Escherichia coli. For the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by 209 Nitrofurantoin SR Tab. 100mg 26.09.08 susceptible strains of Escherichia coli or Staphylococcus saprophyticus For the relief of painful 210 HCl Tablet 50 / 100 / 150mg muscle spasms of the 26.09.08 skeletal musculature For the short term use in 211 Etoricoxib + PCM (60mg + 500mg) Tablets acute painful and 30.09.08 inflammatory condition For the treatment of disturbance of consciousness resulting 212 Citicoline Oral Drops from head injuries, brain 30.09.08 operation & acute stage of cerebral infraction in adult. Indicated for the treatment of mastitis, metritis, Paracetamol + Meloxicam + Benzyl + pneumonia, pleuritis, 213 Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) fever and relieving of 30.09.08 Injection acute pain in musculoskeletal disorders in animals For the treatment of Calcium (as Calcium Citrate Malate) + calcium and Vitamin D 214 Colecalciferol (as Colecalciferol Concentrate) + deficiency states 30.09.08 Folic Acid (250mg + 100IU + 50mcg) Tablets (, lactation, growing Children) for the treatment of chloroquine Artemether + Lumefantrine (80mg + 480mg/5ml) 215 resistant/multidrug 30.09.08 Dry syrup resitant on complicated malaria For the treatment of 216 Cabergoline 1mg Tablets (Additional indication) hyperprolactinemia and 01.10.08 inhibition of lactation. In combination with is indicated for the first line treatment of disodium500mg / 100mg powder for patients with locally 217 08.10.08 sol. (Addl.indication ) advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment Tylvalosin tartrate oral soluble granules Sachet of diseases due to 218 08.10.08 62.5% w/w (Veterinary) clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and treatment of ornithobacterium rhinotacheale (ORT) Treatment of patients with 219 inj.3.5mg/vial (Additional Indication) 09.10.08 multiple myeloma For the treatment of 220 Sertaconazole Nitrate Vaginal Tab.500mg vulvo-vaginal candidiasis 09.10.08 in women For the treatment of uncomplicated urinary tract infections (acute 221 Fosfomycin Tromethamine Sachet 3gms cystitis) in women due to 09.10.08 susceptible strains of E.Coli and Entreococcus faecalis As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose Ixabepilone lyophilized powder (additional tumors are resistant or 222 09.10.08 Indication) refractory to cytotoxic . Previous therapy should have included as anthracycline, a taxane, and capecitabine For the treatment of 223 Eprosartan Mesylate 400 mg / 600mg Tablets 11.10.08 essential hypertension For topical treatment of 224 Tretinoine Gel as Micro Sphere 0.04% % 0.1% 14.10.08 Acne vulgaris. For the treatment of Hydroxychloroquine Sulphate (Additional 225 systemic lupus 17.10.08 indication ) erythematosus Indicated in the regular treatment of patients with Budesonide + Formoterol (80/160mcg + 4.5mcg) moderate to severe COPD 226 17.10.08 Inhalational Powder (Additional Indication) with frequent symptoms and a history of exacerbations For post operative steroid responsive inflammatory Azithromycin + Dexamethasone (10mg + 1mg) Eye ocular condition when 227 21.10.08 Drops bacterial ocular infections or a risk of bacterial ocular infections exists. For the treatment of acute Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) inflammation conditions 228 21.10.08 Capsules associated with spasm in adults only For the treatment of acne 229 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel 24.10.08 vulgaris For the treatment of acute 230 Aceclofenac Roll - On 1% musculoskeletal pain in 24.10.08 patients For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of 231 Citicoline Troches 200/500mg 31.10.08 consciousness and for treatment of degenerative damages and chronic cerebral vascular injuries in senile dementia. For acute and chronic schizophrenic disorders, in which positive symptoms and or negative 232 S.R.Bilayered tablet 200/400mg symptoms are prominent, 03.11.08 including patients characterised by predominant negative symptoms. For the treatment of Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 233 hypocalcaemia and/or 04.11.08 7.5mg) Capsules osteoporosis For the treatment of Atazanavir + Ritonavir(300mg + 100mg) FC 234 patients with HIV 04.11.08 Tablets infection For the treatment of elevated intraocular 235 Timolol Maleate SR Eye Drops 5.0mg / ml pressure in patients with 08.11.08 ocular hypertension or open angle glaucoma. 1) As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. 2)As an adjunctive 236 08.11.08 Indication) 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.

For the treatment of 237 Paclitaxel inj.30/100/300mg vial (Addl. Indication) advanced gastric 08.11.08 carcinoma For the treatment of Montelucast + Desloratidine(10mg + 5mg) FC 238 allergic rhinitis in adults 10.11.08 Tablets only Amlodipine + Metoprolol (2.5/5 mg + 25/50mg Additional Lower 239 10.11.08 (ER))Tablets Strength

240 Losartan + HCTZ (100 mg + 25 mg) Tablets Additional Strength 10.11.08

For the treatment of 241 Phenyramidol HCl tablet 400mg lumbago, integumental 14.11.08 pain, musculoskeletal pain For scaling of seborrhea, 242 Salicylic Acid + Coal Tar (3% + 1%) Solution seborrheic dermatitis, 17.11.08 psoriasis of scalp For the treatment of Salicylic Acid + Coal Tar + Precipitated Sulphur 243 psoriasis and fungal skin 17.11.08 (3% + 1% + 3%) Ointment infection For the acute treatment of inflammatory Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC 244 musculoskeletal disorders 17.11.08 Tablets associated with painful muscle spasm in adults.

Tamsulosin + (0.4mg MR Pellets + Additional Lower 245 17.11.08 2mg/4mg ER Pellets) Capsules Strength

For purification of Calcium Hypochlorite 4gm Sachet (Calcium 246 contaminated ground 23.11.08 Hypochlorite 0.542% Other Ingredients: 99.458%) water sources.

Additional Lower 247 + Naproxen (50mg + 275mg) Tablets 24.11.08 Strength For the treatment and management of patients with community acquired Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC 248 pneumonia or acute 25.11.08 Tablets bacterial sinusitis due to beta lactamase producing pathogens

Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 Additional Lower 249 02.12.08 mg) Tablets Strength

As adjunctive therapy to Atorvastatin + Metformin(10mg + 500mg SR) diet and exercise in 250 04.12.08 Tablets patients with diabetic dyslipidemia As monotherapy for the second-line treatment of patients with locally Pemetrexed disodium 500mg / 100mg powder for 251 advanced or metastatic 04.12.08 sol. (Addl. Indication) non-small cell lung cancer other than predominantly squamous cell histology For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. For 252 Magnesuim Valproate Tablet 200mg/400mg the treatment of maniac 04.12.08 episodes associated with bipolar disorders. For prophylaxis of migraine headache in adults. For the dissolution of Radiolucent collestral goll stone, chronic cholestatic liver disease in particular Ursodeoxycholic Acid 300/600 SR Tablets 253 primary biliary cirrhosis, 08.12.08 (Additional Strength) primary sclerosing cholangitis & cholestasis associated with cyatic fibrosis. For the treatment of adult + INH + (200mg + 300mg + 254 patients with pulmonary 11.12.08 10mg ) Capsules tuberculosis For the treatment of adult 255 Rifampicin +Piperine (200mg + 10mg ) Capsules patients with pulmonary 11.12.08 tuberculosis

Amphotericin B Lipid suspension 50mg/ vial (Addl. 256 Additional Strength 12.12.08 Strength)

For the treatment of cranial diabetes insipidus , 257 Desmopressin Acetate tablet 0.1/0.2 mg 12.12.08 primary noctumal enuresis in patients. For the medical termination of intrauterine + Misoprostol (1 tab of mifepristone pregnancy (MTP) of up to 258 200mg and 4 tab of misoprostol 200mcg) 16.12.08 63 days gestation based on Combipack the first day of the last menstrual period For the treatment of 259 MR Tablets 50/100mg . (addl. 17.12.08 Indication) For the treatment of different Gastro intestinal problems like functional Levosulpride Injection 25mg/2ml (Additional dyspepsia, nausea, 260 17.12.08 Strength) vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults. As an adjunct to rest and physical therapy for relief of muscle spasm 261 Cyclobenzaprine HCl ER Capsule 15/30mg 17.12.08 associated with acute, painful, musculoskeletal conditions. In combination with cisplatin and 5- is indicated Docetaxel injection concentrate 80mg/2ml, for the induction treatment 262 17.12.08 20mg/0.5ml (Additional Indication ) of patients with locally advanced squamous cell carcinoma of the head and neck. Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol For the treatment of scaly 263 18.12.08 (2% + 2.65% + 0.26%) Lotion dermatoses

264 Azathioprine 25mg Tablets Additional Strength 19.12.08 For short term treatment of moderate pain, especially following 265 Paracetamol solution for infusion 10mg/ml surgery and for the short 23.12.08 term treatment of fever, when administration by i.v route is clinically justified Indicated for the treatment Gemifloxacin + Ambroxol (320mg + 75mg SR) FC 266 of lower respiratory tract 24.12.08 Tablets infections in adult patients 1. For LRTI infections, 2. for UTI - Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic Ceftazidime + Sulbactam (500/1000mg + 267 infections including 24.12.08 250/500mg) Injection endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis

For the treatment of fever Paracetamol + Phenylephrine Hydrochloride (Each 268 associated with cold, nasal 24.12.08 6gm Sachet contains: 500mg + 10mg) Sachet congestion in adults

Carboinoxamine Maleate + Ammonium Chloride + For symptomatic 269 Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg 24.12.08 treatment of cough + 120 mg) syrup

Diclofenac + Thiocolchicoside (50 mg + 4 mg) Additional Lower 270 24.12.08 Capsules Strength