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

 

S.No. Drug Name Indication Approval Date
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 1 tablet of  sulphadoxine 500mg+ pyrimethamine 25 mg                                                              

D. combipack of  1 stip of 3 tablets of artesunate 200 mg and 1 strip of 1 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.                                            For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severly immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.  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 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

Continued..........

 

Important Links

Ministry of Health & Family Welfare, Govt. of India

National Pharmaceutical Pricing Authority

Department of AYUSH

Department of Chemicals and Petrochemicals

Central Council for Research in Ayurvedic Sciences

Medical Council of India

Pharmacy Council of India

Nursing Council of India

Indian Pharmacist Association

Indian Medical Association

 



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