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年份导航: |
1999年 | 2000年 | 2001年 | 2002年 | 2003年 | 2004年 | 2005年 | 2006年 | 2007年 | 2008年 | 2009年 | 2010年 | 2011年 |
No | Name Of Drug | INDICATION | DATE OF APPROVAL | |||
1 | Zoledronic Acid Injection 5mg/100ml (Addl. Indication) | For the treatement of osteoporosis in post-menopausal women and in men who are at increased risk of fracture,including those with a recent low-trauma hip fracture. | 07.01.09 | |||
2 | Misoprostol Tablet 600mcg | Addl. Strength | 09.01.09 | |||
3 | Acebrophylline Syrup 10mg/ ml | For the treatement of adult patients with chronic obstructive pulmonary disease(COPD) and bronchial asthma. | 09.01.09 | |||
4 | Selamectin Tropical solution (for verterinary use.) 60mg/120mg per ml | (I) For the treatement and lasting prevention of flea infestations,treatment and control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs and cats; (II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs. | 09.01.09 | |||
5 | Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules | For the treatment of vitamin deficiency states in adults | 14.01.09 | |||
6 | Metoprolol tartrate tablets 50 mg (Addl. Indication) | Adjunct to the treatement of Hyperthyroidism | 14.01.09 | |||
7 | Cinacalet (as HCl) Tablet 30/60/90mg | For the treatment of secondary hyper parathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma | 14.01.09 | |||
8 | Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral suspension 200mg/ml (addl. Indication) | For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation. | 23.01.09 | |||
9 | Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml | For symptomatic treatment of constipation in adults | 29.01.09 | |||
10 | Ranolazine 1000mg ER Tabs (Additional Strength) | Same as approved | 31.01.09 | |||
11 | Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml | For intradermal implantation and facial soft tissue augmentation | 31.01.09 | |||
12 | Caspofungin acetate Injection (Addl. Indication) | For use in following: (I) Empirical therapy for presumed fungal infections in febrile neutropenic patients. (II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleural space infections. (III) Treatment of Esophageal Candidiasis. (IV) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole) | 31.01.09 | |||
13 | Micafungin ( as sodium) Powder for solution for infusion 50mg / vial | For the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT) | 31.01.09 | |||
14 | Loteprednol Etabonate Nasal spray 0.1% w/v | For prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis. | 31.01.09 | |||
15 | Rasagiline (as mesylate ) Tablet 0.5mg/1mg | For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa. | 31.01.09 | |||
16 | Nicotine Polacrilex Gum 2mg & 4mg (Addl. Indication) | To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco. | 03.02.09 | |||
17 | Closantel Injection100mg/ ml (for verterinary use.) | For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals. | 05.02.09 | |||
18 | Lornoxicam 4mg + Paracetamol 500mg film coated tablets | For the short term use in acute painful & inflammatory conditions in adults | 05.02.09 | |||
19 | Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution | For cleansing of physically contaminated wounds and for pre-operative disinfection | 09.02.09 | |||
20 | Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution | For the treatment of dandruff | 09.02.09 | |||
21 | Doripenem (as monohydrate) Injection 250mg/500mg | For the treatment of nosocomial pneumonia in adults. | 16.02.09 | |||
22 | Halobetasol Scalp Approved 0.05% w/v | For the relief of inflammatory and puritic manifestation of corticosteroid respensive dermatosis | 18.02.09 | |||
23 | Nicotine (as Polacrilex) Lozenges 2mg & 4mg | To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco. | 18.02.09 | |||
24 | Tranexamic Acid Tab SR 750mg | For the treatment of menorrhagia | 20.02.09 | |||
25 | Betahistine Mesilate Tablet 6mg/12mg | For the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo. | 20.02.09 | |||
26 | Abatacept Injection 250mg/vial (Addl. Indication) | In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists | 20.02.09 | |||
27 | Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial | For the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients. | 23.02.09 | |||
28 | Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream | For the treatment of patients with skin hyperpigmentation | 23.02.09 | |||
29 | Doxyphylline 400 mg + Terbutaline 5mg tablets | For the treatment of asthma and chronic obstructive pulmonary disease in adult patients only | 23.02.09 | |||
30 | Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream | For the treatment of melasma of face in adults | 23.02.09 | |||
31 | Ketoconazole 2% + Zinc Pyrithone 1% Lotion | For the treatment of pityriasis and dandruff of the scalp | 23.02.09 | |||
32 | Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg Oral Suspension (Tablets for oral Suspension) | For the treatment of HIV patients | 23.02.09 | |||
33 | Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets | As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control | 23.02.09 | |||
34 | Aceclofenac 100mg + Tizanidine 2mg film coated tablets | For the treatment of acute low back pain in adult patients only | 23.02.09 | |||
35 | Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotion | As sunscreen lotion for prevention of sunburn skin | 23.02.09 | |||
36 | Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup | For the symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired | 23.02.09 | |||
37 | Lidocaine Lozenges 200/300mg | For single agent anesthesia in upper gastro intestinal endoscopy. | 26.02.09 | |||
38 | Calamine 8% + Liquid Paraffin10% lotion | As antipruritic and smoothening agent | 26.02.09 | |||
39 | Nifedipine 0.3% + Lidocaine1.5% cream | For the treatment of anal fissures | 26.02.09 | |||
40 | Quinapril 20mg + HCTZ 25mg film coated tablet | For the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion | 26.02.09 | |||
41 | Levodopa 100/100/250 + Carbidopa 10/25/25mg mouth dissolving tablet | For the symptomatic symptoms of idiopathic Parkinson's Disease | 04.03.09 | |||
42 | Paliperidone ER Tablets 1.5mg | Addl. Strength | 04.03.09 | |||
43 | Losartan 100mg+ HCTZ 25 mg tablet | Additional higher strength | 16.03.09 | |||
44 | Darunavir(as ethanolate) Tablet 300mg | For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents. | 19.03.09 | |||
45 | Ropivacaine HCl Inj.2/5/7.5/10mg | For the production of local or regional anasthesia for surgery and for acute pain management. | 19.03.09 | |||
46 | Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder (Veterinary Drug) | As vitamin and phosphorous supplement for livestock, shirmp and fish. | 19.03.09 | |||
47 | Fluticasone furoate Nasal spray 27.5mcg per spray | For the treatment of symptoms of allergic rhinitis. | 19.03.09 | |||
48 | Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion | A sunscreen lotion for prevention of sunburn skin | 19.03.09 | |||
49 | Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet | Additional Strength | 19.03.09 | |||
50 | Ambroxol 30mg + Levo salbutamol 1mg+ Guiphenesin 50mg /5ml syrup | For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis | 19.03.09 | |||
51 | Montelucast 4 mg+ Levocetrizine 2.5 mg tablet | Additional lower paedriatric dose | 19.03.09 | |||
52 | Surgical Sealant | To be indicated for use in sealing suture lines along arterial and venous reconstructions. | 26.03.09 | |||
53 | Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive) | For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. | 26.03.09 | |||
54 | Bimatoprost Opthalmic solution 0.03% | For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. | 30.03.09 | |||
55 | Trabectedin powder for concentrate for solution for infusion 1 mg/ vial | For the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents. | 30.03.09 | |||
56 | Acebrophylline Syrup 10mg/ml (Additional Indication) | For the treatment of children (age 6to 12years) with chronic obstructive pulmonary disease(COPD) and bronchial asthma. | 30.03.09 | |||
57 | Mesalamine PR Tablets 1.2gm | For the induction of remission in patients with active, mild to moderate ulcerative colitis. | 30.03.09 | |||
58 | Mycophenolate Mofetil Tablets 750mg Additional Strength | Same as approved | 31.03.09 | |||
59 | Ketorolac Tromethamine Gel 2%w/w | For the treatment of muscle, joint and post-traumatic stress. | 31.03.09 | |||
60 | Theophylline 400mg SR + Montelukast 10mg Tablet | For the treatment of patients with bronchial asthma | 31.03.09 | |||
61 | Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream. |
For the treatment of wound of different etiology | 31.03.09 | |||
62 | Telmisartan 80mg + Amlodipine 5mg tablet | Additional higher strength | 31.03.09 | |||
63 | Hyaluronic Acid Sodium Salt (i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mg | For the treatment of wound of different etiology | 31.03.09 | |||
64 | Abatacept Injection 250mg/vial? (additional indication) | For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARD's such as MTX | 10.04.09 | |||
65 | Cetrizine 10 mg + Ambroxol 75 mg SR Tablet | For symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired | 13.04.2009 | |||
66 | Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI | Indicated as third line treatment of severe cases of? COPD, when monotherapy and second line therapy with two drugs do not respond adequately. | 13.04.2009 | |||
67 | Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mg | For the tretament of patients with mild to modrate essential hypertension | 13.04.2009 | |||
68 | Milnacipran 25/50mg Caps????? (Addl. Indication) | For the management of fibromylagia. | 15.04.2009 | |||
69 | Lornoxicam SR 16mg Tabs | For the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis | 25.04.2009 | |||
70 | Palonosetron Hcl 0.075mg IV Inj (Addl. Strength) | Same as approved | 25.04.2009 | |||
71 | Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg | Additional strength | 25.04.2009 | |||
72 | Albendazole 400 mg + Ivermectin 6 mg tablet?? | For the treatment of intestinal helminthes and suppression of microfilaraemia especially with bancrofti infections | 25.04.2009 | |||
73 | Decitabine Lyophilized powder for injection 50mg/20ml vial | For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international Prognostic Scoring System groups. | 25.04.2009 | |||
74 | Retapamulin Ointment 1% | For the topical treatment of bacterial skin and skin structure infections:- Primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses. | 25.04.2009 | |||
75 | Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+ Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion | For the tretament of pruritis and prickly heat | 08.05.2009 | |||
76 | Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3? acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion | For the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults? if oral or enteral nutrition is impossible, inadequte or contraindicated. | 14.05.2009 | |||
77 | Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v | For the topical treatment of the superficial fungal infections of the skin. | 02.05.2009 | |||
78 | Amlodipine Tablets 5mg/10mg? (additional indication) | 1. To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke.?????????????????????????????????? 2. To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease. | 02.05.2009 | |||
79 | Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (additional indication) | Prophylaxis of infection in neck and head surgery | 02.05.2009 | |||
80 | Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules | For the treatment of chronic idiopathic constipation in adult patients only | 16.05.2009 | |||
81 | Sucralose | for use as sweetner in drug formulations | 09.05.2009 | |||
82 | CarvedilolTablets 3.125/6.25/12.5/25mg? (additional indication) | To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure) | 09.05.2009 | |||
83 | Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets | For the treatment of Acute musculoskeletal pain | 18.05.2009 | |||
84 | Pregabalin SR Tablet 150/300mg | For the treatment of peripheral neuropathic pain in adults | 16.05.2009 | |||
85 | Guaiphenesin ER Tablet 1200mg | For the treatment of productive cough accompanied by Phlegm | 16.05.2009 | |||
86 | Everolimus 5/10mg Tablets (Addl. Indication) | Treatment of advance renal cell carcinoma | 16.05.2009 | |||
87 | Nimesulide ER 200mg ( Additional Indication) | Acute pain in Orthopaedic, ENT, Dental and Post Operative condition | 16.05.2009 | |||
88 | Palonesetron Injection 0.25mg/5ml (Additional Indication) | For treatment of Post Operative Nausea & vomiting | 16.05.2009 | |||
89 | Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial | For the treatment of patients with chronic lymphocytic leukemia. | 16.05.09 | |||
90 | Caffeine(as? Citrate)?????? 10mg / ml Injection | For the short term treatment of apnoea of prematurity of infants between 28 and < 33 weeks gestational age. | 16.05.09 | |||
91 | Perindopril arginine 2.5mg/5mg/10mg? film coated tablet | For the treatment of arterial hypertension, congestive heart failure and coronary artery disease. | 16.05.09 | |||
92 | Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel | For the topical treatment of inflammatory dermatitis with secondry bacterial infection | 16.05.09 | |||
93 | Mometasone 0.1 % + Fusidic acid 2% cream/ointment | For the treatment of dermatoses where secondry bacterial and/or candidial infection is present | 25.04.09 | |||
94 | Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets | Additional strength | 25.04.09 | |||
95 | Methadone Hydrochloride 5mg/10mg per ml syrup;? 5mg/ 10mg/ 20mg / 40mg? tablet | For the treatment of opiod dependence and in maintainence treatment for opioid dependence. | 28.05.09 | |||
96 | Trospium Chloride? film coated tablet 20mg | For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frequency. | 28.05.09 | |||
97 | Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution | For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. | 29.05.09 | |||
98 | Zolmitriptan...5.0% w/v?? Benzalkonium Chloride NF ... 0.01% w/v??????? Nasal spray | For the acute treatment of migraine with or without aura in adults. | 29.05.09 | |||
99 | ? Dexmedetomidine ( as HCl) 100mcg /ml Injection | For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting. | 29.05.09 | |||
100 | Levetiracetam SR Tablet 500/750/1000mg | same as approved ? | 2.05.2009 | |||
101 | Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml) | For the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis. | 3.06.2009 | |||
102 | ? Yttrium-90 Microspheres Injection? (Yttrium-90...3GBq (at the time of calibration) per vial) | For the treatment of unresectable metastatic liver tumors from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine) | 3.06.2009 | |||
103 | ? Luliconazole Cream 1% | For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris. | ? 3.06.2009 | |||
104 | ? Magnesium Valporate Prolonged release tablet 600mg | 1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis of migraine headache in adults. 3) For the treatment of manic episodes associated with bi polar disorders | ? ? 4.06.2009 | |||
105 | Tenofovir Disoproxil Fumerate 300mg | For the treatment of chronic Hepatitis B in adults | 19.6.2009 | |||
106 | ? Bosentan (as monohydrate) Tablets 62.5/125mg | For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve excercise ability and decrease the rate of clinical worsening. | ? 23.6.2009 | |||
107 | Lornoxicam 12 mg SR (additional strength) | same as approved | 26.6.2009 | |||
108 | ? Azithromycin SR Granules for oral suspension? 2000mg | for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/ skin structure, non gonococcal urethritis, cervicitis | ? 26.6.2009 | |||
109 | ? Metoprolol 50/50/25 mg? + Atorvastatin 20/10/10 mg? + Ramipril 10/5/2.5 mg capsules | As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive with lipid lowering agent. | 1.07.2009 | |||
110 | Methyl Phenidate ER Tablet 10/20/30mg | For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) | 10.07.2009 | |||
111 | Dasatinib Tablets 100mg (addl. Strength) | same as approved | 10.07.2009 | |||
112 | ? Voglibose 0.2 mg? + Metformin 500mg Tablets | As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control. | 13.7.2009 | |||
113 | Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine Composition: A. combipack of? 1 stip of 3 tablets of artesunate 25 mg and 1 strip of 1 tablet of? sulphadoxine 125mg+ pyrimethamine 6.25 mg B. combipack of? 1 stip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of? sulphadoxine 500mg+ pyrimethamine 25 mg C. combipack of? 1 stip of 3 tablets of artesunate 100 mg and 1 strip of 2 tablet of? sulphadoxine 500mg+ pyrimethamine 25 mg D. combipack of? 1 stip of 3 tablets of artesunate 200 mg and 1 strip of 3 tablet of? sulphadoxine 500mg+ pyrimethamine 25 mg. |
For the treatment of P. falciparum resistant malaria patients ? ? ? ? ? ? ? ? ? ? ? | 15.7.2009 | |||
114 | Milnacipran 100mg (additional Strength) | same as approved | 16.7.2009 | |||
115 | Rifaximin 400mg (additional Indication) | For the treatment of hepatic encephalopathy | 18.7.2009 | |||
116 | Nevirapine tablet 50 mg for oral suspension mg | For the treatment of HIV infection in combination with other anti retro viral agents | 18.7.2009 | |||
117 | Desvenlafaxine (as Succinate) ER Tablets? 50mg/100mg | For the treatment of major depressive disorder (MDD) | 18.7.2009 | |||
118 | Posaconazole Oral Suspension 40mg/ml | For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. |
18.7.2009 | |||
119 | Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form) | same as approved | 18.7.2009 | |||
120 | Amphotericin B Emulsion 5mg/ml (Addl. Indication) | Febrile Neutropenia in cancer patients | 18.7.2009 | |||
121 | Hydroxy ethyl starch 10% Solution for infusion | For the treatment of imminent or manifest hypovolemia and shock. | 18.7.2009 | |||
122 | Naratriptan (as HCl)? Tablets 1/ 2.5mg | For the acute treatment of migraine with or without aura in adults. | 18.7.2009 | |||
123 | Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU (additional Strength) | same as approved | 20.7.2009 | |||
124 | Simvastatin 20 mg + Ramipril 5mg? + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules | For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate | 21.7.2009 | |||
125 | Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU | Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis | 28.7.2009 | |||
126 | Ramipril MR capsule 10mg | For the treatment of hypertension/ cardiac failure and myocardial infarction | 30.7.2009 | |||
127 | Abacavir Sulfate Tablet 60mg | For the treatment of HIV-1 infection in combination with other antiretroviral agents | 1.08.2009 | |||
128 | Zoledronic Acid Solution for Infusion Addl. Indication | Prevention of clinical fractures after hip fracture in men and women | 1.08.2009 | |||
129 | Sumatriptan 85 mg + Naproxen 500 mg Tablets | Additional Strength? for the treatment of migraine | 3.08.2009 | |||
130 | Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets | For the treatment of acute inflammation conditions associated with spasm in adults only | 3.08.2009 | |||
131 | Oxcarbazepine 150/300/600mg Tablet (Addl. Indication | Treatment of generalized tonic-clonic seizures in adults and children | 13.08.2009 | |||
132 | Ofloxacin 2mg + Ornidazole 5 mg? per ml Infusion | for the treatment of diarrhoea of mixed infection in adult patients | 17.08.2009 | |||
133 | Clozapine Tablet200mg (Addl. Strength) | Indicated in the management of Schizophrenic patients | 19.08.2009 | |||
134 | Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w | Is indicated for the relief of stuffy,running nose associated with colds and influenza, also post nasal drip, sinusitis. | 19.08.2009 | |||
135 | Enoxaparin Sodium Injection (Addl.Indication) | Treatment of acute ST-segment elevation myocardial infarction including patients to be managed medically or with subsequent percuaneous coronary intervention (PCI) | 19.08.2009 | |||
136 | Fluvoxamine Maleate100/150mg ER Tablets | For the treatment of obsessive compulsive disorder (OCD)and depression | 19.08.2009 | |||
137 | Lidocaine Lozenges 200/300mg (Addl. Indication) | For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract. | 19.08.2009 | |||
138 | Risperidone long acting injection (Addl. Indication) | Indicated as monotherapy or as adjunctive therapy in lithium? or valproate for the maintenance treatment of Bipolar-1 disorder. | 29.08.2009 | |||
139 | Exemestane 25mg Tablet (Addl. Indication) | Indicated for adjuvant treatment of Post Menopausal Women with estrogen receptor positive early breast cancer who have received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy. | 29.08.2009 | |||
140 | Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets | For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups | 01.09.2009 | |||
141 | Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets | For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function | 01.09.2009 | |||
142 | Buprenorphine Transdermal Patch Each Transdermal Patch having an area of?? 6.25cm2, 12.5cm2, and 25cm2contains: Buprenorphine…5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days). |
For the treatment of severe opioid responsive painconditions which are not adequately responding to non-opioid analgesics.For Hospital supply only. | 03.09.09 | |||
143 | ?Trospium Chloride ER Capsules 60 mg? | For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency. | ?04.09.2009 | |||
144 | Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution | For the treatment of nausea and vomiting. | 09.09.09 | |||
145 | Isosorbibe 20 mg? + Hydralazine 37.5 mg tablets | For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status. | 18.09.2009 | |||
146 | Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets | For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections | 22.09.2009 | |||
147 | Chlorthalidone Tablet 6.25mg?????????????? | For the treatment of mild to moderate hypetension. | 03.10.09 | |||
148 | Cefovecin( as sodium) 80mg/ ml? Lyophilised powder for injection? (Veterinary)????????????? | For the treatment of skin bacterial infections in dogs and cats. | 03.10.09 | |||
149 | Imidacloprid 10% + Moxidectin 1.0% & 2.5%?? Topical solution (Veterinary)???????????Each pippette contains:?????????????????????????????(a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin???????????? (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin?? | For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats. | 03.10.09 | |||
150 | Isoflupredone AcetateSuspension for Injection (2mg per ml) ( For Veterinary) | For the glucocorticoid, anti-inflammatory or supportive therapy to cattle suffering from conditions such as: (1) Overwhelming infections with severe toxicity.?????????????????????????????????????????????????????????????? (2)?? Bovine ketosis. (3)? Musculoskeletal conditions. (4)? Shock. (5) Parturient paresis (supportive stress? therapy for milk fever). |
03.10.09 | |||
151 | Saxagliptin (as HCl) 2.5mg/ 5mg Tablets | As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. | 24.10.09 | |||
152 | Calcipotriol Gel 0.005%??????????????????????? (additional dosage form) | For the treatment of moderate plaque psoriasis in adults | 3.10.2009 | |||
153 | Lamotrigine MR Tablets 150mg (Addl. Strength) | same as approved | 3.10.2009 | |||
154 | Metoprolol Tartrate ER Tablet 75mg????????????????????????????????????????????????? (additional strength) | same as approved | 3.10.2009 | |||
155 | 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 | |||
156 | Dexketoprofen Trometamol Gel 12.5mg/gm | For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle | 13.10.2009 | |||
157 | Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg | For the treatment of mild to moderate severe Alzheimer's Dementia | 15.10.2009 | |||
158 | 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 | |||
159 | 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 | |||
160 | Levosulpride ER Tablet 100/150/200mg | For the treatment of depression and schizophrenia in adults | 27.10.2009 | |||
161 | Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup | Additional strength | 27.10.2009 | |||
162 | Propofol 10 mg+ Lignocaine 2.5 mg per ml injection | Additional strength | 27.10.2009 | |||
163 | Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets | For the treatment of diabetic neuropathy | 27.10.2009 | |||
164 | 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 | |||
165 | 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 |
29.10.2009 | |||
166 | 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 | |||
167 | Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets | Additional strength? | 4.11.2009 | |||
168 |
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169 |
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For the management of seasonal allergic rhinitis (SAR) | 10.11.2009 | |||
170 | 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 | |||
171 | 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. |
11.11.2009 | |||
172 | 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? chemotherapy. 2. Tablets 2.5mcg & 5mcg--- for the treatment of diarrhoea predominant irritable bowel syndrome. |
11.11.2009 | |||
173 | Tadalafil tablet 20 mg (Additional Indication) | For the treatment of pulmonary arterial hypertension | 14.11.2009 | |||
174 | Flurbiprofen Sodium 0.03% Ophthalmic solution USP | for the reduction of post-operative inflammatory condition | 14.11.2009 | |||
175 | Dexmedetomidine HCl Injection (Additional Indication) | Sedation of non-intubated patients prior to and/or during surgical and other procedure | 14.11.2009 | |||
176 | Paliperidone ER tablet 12 mg (Additional Strength) | Same as approved | 14.11.2009 | |||
177 | 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.? |
14.11.2009 | |||
178 | 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 | |||
179 | Euphorbia Prostrata Dry Extract :100mg tablet (addl. Indication) | For the treatment of 3° and 4° haemorrhoids (Addl. Indication). | 14.11.2009 | |||
180 | 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 | |||
181 | Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules? | For the treatment of acute diarrhoea in children? | 4.11.2009 | |||
182 | 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 | |||
183 | Diacerein Modified Release Capsule 100mg | Symptomatic treatment of osteoarthritis of knee & hip | 20.11.2009 | |||
184 | 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 | |||
185 | Maraviroc Tablets 150mg/300mg. | For the treatment of patients infected with CCR5- trophic HIV-1. | 25.11.2009 | |||
186 | 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 | |||
187 | 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 | |||
188 | Rifaximin Dispersible Tablet 200mg | For infections diarrhoea in adults | 26.11.2009 | |||
189 | 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 | |||
190 | Cinitapride Hydrogen Tartrate ER Tablet 3mg | For the treatment of gastroesophageal reflux disease (GERD) and functional inconveniences of the gastrointestinal motility | 26.11.2009 | |||
191 | 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 | |||
192 | Oxcarbazepine Tablets (Additional Indication)150/300/600 mg | Monotherapy in the treatment of partial seizures in children ages 4-16? | 26.11.2009 | |||
193 | Ketoprofen plaster 30 mg (7cm X 10 cm) | for the relief of musculoskeletal pain & inflammation | 11.12.2009 | |||
194 | 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 | |||
195 | Amisulpiride SR Tablet 100 mg | Same as approved | 27.11.2009 | |||
196 | Mycophenolate Sodium Enteric coated tablet 540 mg (Additional Strength) | Same as approved | 29.10.2009 | |||
197 | 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 | |||
198 | Ropinirole ER tablet 2/4/8mg | for the treatment of signs & symptoms of idiopathic Parkinson's disease | 3.12.2009 | |||
199 | Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional Strength) | same as approved | 4.12.2009 | |||
200 | Lornoxicam ER Tablet 8 mg (Additional Strength) | same as approved | 11.12.2009 | |||
201 | Flurbiprofen plaster 20 mg (7cm X 10cm) | for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder | 11.12.2009 | |||
202 | 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 | |||
203 | 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 | |||
204 | 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 | |||
205 | 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 | |||
206 | 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 | |||
207 | 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 | |||
208 | Guaiphenasin Syrup 133mg/5ml | For the treatment of productive cough accompanied by phlegm | 18.12.2009 | |||
209 | Balofloxacin Tablet 100mg | for the treatment of uncomplicated urinary tract infectins (such as cystitis and urethritis) | 22.12.2009 | |||
210 | Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray | For symptomatic treatment of nasal congestion with running nose (rhinorrhea) | 23.12.2009 | |||
211 | 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 | |||
212 | Ribavirin Capsules 200mg (Addl. Strength) | Indicated in combination with peg interferon alpha-2b for the treatment of na?ve adult patients with chronic hepatitis C with clinically stable HIV co-infection. | 24.12.2009 | |||
213 | 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 | |||
214 | Chlorohexidine Gluconate Gel 0.2% | For the prevention of Plaque and treatment of gengivitis. | 30.12.2009 | |||
215 | Chlorohexidine Gluconate Mouth wash 0.1% | For the prevention of Plaque and treatment of gengivitis. | 30.12.2009 |
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