|
LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12.2009 |
|||
|
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 |
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. 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 |
Isoflupredone
AcetateSuspension for Injection (2mg per ml) ( For Veterinary) |
For the
glucocorticoid, anti-inflammatory or supportive therapy to cattle
suffering from conditions such as: |
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 |
|
|
|
|||
|
169 |
|
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 naïve 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 | |||
| 216 | Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup | For the treatment of non-productive cough | 06.07.09 |