LIST OF APPROVED DRUG FROM 01-01-2013 to Till Date
S.No Name Of D!" I#$i%atio# Date of i&&!e
1. Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium 2.00 % w/v + ethyl Salicylate !P 10.00% w/v + enthol ".00 % w/v + #$%olute #lcohol !P 10.00 % v/v &o'ical Solution (#dditional St)en*th+ ,o) the &)eatment of #cute -owe) Bac. Pain 01.01.2013 2. &elmi%a)tan 20m* + #mlodi'ine Be%ylate Eq. to #mlodi'ine 2."m* + /yd)ochlo)othi0ide 1.2"m* &a$let% (#dditional St)en*th+ ,o) the &)eatment of E%%ential /y'e)ten%ion 03.01.2013 3. #mlodi'ine $e%ilate !P Eq. to #mlodi'ine 10m* + !nda'amide S2 1." m* &a$let (#dditional St)en*th+ ,o) the t)eatment of mild to mode)ate /y'e)ten%ion 02.01.2013 3. Nicoumalone Tablets 0.5mg/5mg/6mg For the prevention and treatment of thromboembolic diseases such as venous thrombosis, atrial fbrillation with emboliation, pulmonar! embolism and as an ad"unct in the treatment of coronar! occulsion. #$.#.#% ". 2u4olitini$ &a$let "m*/1"m*/20m* ,o) the t)eatment of 'atient% with myelofi$)o%i% includin* ')ima)y myelofi$)o%i%5 'o%t6'olycythemia ve)a myelofi$)o%i% o) 'o%t6e%%ential th)om$ocythemia myelofi$)o%i%. 27.01.2013 1. &abigatran'te(ilate)esilatee* to &abigatran'te(ilate +5mg/##0mg/#50mg For the prevention of venous thromboembolic events in patients who have undergone orthopaedic surger! ##.,.#% 8. &e(amethasone -ntravitreal -mplant 0.+mg .in solid pol!mer drug deliver! s!stem/ For the treatment of non0 infectious uveitis a1ecting the posterior segment of the e!e. 2owever it should not be used when there is gap in posterior capsule. ,0.,.#% 7. 3ef(ime Tablets ,00mg 43ef(ime 5ral 6uspension #00mg/5ml For the treatment of enteric .t!phpoid/ fever. ,,.,.#% 9. &iclofenac 3olest!ramine #75.6mg 3apsule 3orresponding to &iclofenac 6odium +5mg .8dditional -ndication/ For the treatment of post0 traumatic or post0operative swelling and in9ammation ,5.,.#% 10. 6aroglitaar ,mg/7mg Tablets For the treatment of diabetic d!slipidemia and h!pertrigl!ceridemia with t!pe0, diabetes mellitus not controlled ,5.,.#% b! statin therap! 11. Tadalafl Tablet ,.5mg/5mg #.For the treatment of erectile d!sfunction. ,. For the treatment of erectile d!sfunction with benign prostatic h!perplasia. ,+.,.#% 12. 8ithrom!cin Tablet ,50mg/500mg For the treatment in uncomplicated multidrug resistant enteric fever onl! 6.%.#% 13. :etahistine&ih!drochloride 6; Tablets ,7mg/%,mg/7$mg For the s!mptomatic treatment of peripheral vertigo #7.%.#% 13. <alonosetron )elt in )outh Tablets 0.5mg For prevention of chemotherap! induced nausea and vomiting #=.%.#% 1". -obitridol 6olution for -n"ection 'ach #00mg solution contain 65.$# g -obitridolcorressponding mass of -odine %0gm :! intracavit! route for 8rthrograph! and 2!sterosalpingograph!. #=.%.#% 11. 'verolimus ,.5mg/5mg/#0mg Tablets #. For the treatment of tuberous sclerosis comple( .T63/ who have renal angiom!olipoma not re*uiring immediate surger!. ,. For the treatment of postmenopausal women with hormone receptor positive advanced breast cancer in combination with an aromatase inhibitor. ,#.%.#% 18. Each %u%tained )elea%e ta$let contain%: &hiocolchico%ide !P 7/11m* + -o)no4icam 7/11m* (#dditional St)en*th+ ,o) the t)eatment of 'atient% with acute 'ainful mu%culo%.eletal condition% 07.03.2013 17. 3ombination of >actic 8cid :acteria .?6>@%/ 6achet For mild to moderatel! active ulcerative colitis as an ad"unctive therap! sub"ect to condition that it should not be used in patients who are on steroids or immunocompromised. $.7.#% 19. &ol'e)i%one /;l 3"0m* + Diclofenac Sodium !P100m* S2 ta$let% (#dditional St)en*th+ ,o) the t)eament of Patient% with acute mu%cle/mu%culo %.eletal %'a%m in adult 12.03.2013 20. &elmi%a)tan !P 70m* + /yd)ochlo)othia0ide !P 2"m* uncoated $ilaye)ed ta$let (#dditional St)en*th+ ,o) the t)eatment of hy'e)ten%ion a% %econd line the)a'y 13.0".2013 21. 3arbo(! )eth!l 3ellulose 6odium >ubricant '!e &rops 0.5A w/v .Bnit dose pacC without preservative/ For temporar! relief from burning irritation and discomfort due to dr!ness of the e!e or due to e(posure to wind or sun. )a! also be used as a protectant against further irritation. ,+.5.#% 22. Dareno(acin )es!late tablets ,00mg For the treatment of bacterial respirator! tract infection 0+.06.#% 23. Trimetho(!sil!l Euaternar! 8mmonium 3hloride 0.70A hand protectant and sanitier 2and <rotectant and 6anitier for e(ternal use. '1ective upto ,7 hours. ##.06.#% 23. -ron .---/ isomaltoside #000 solution for in"ection/infusion #00mg per ml For the treatment of iron defcienc! anaemia when oral iron preparations are ine1ective or cannot be used and when there is a clinical need to deliver iron rapidl!. ,0.0$.#% 2". F&3 of 8eterolane )alate .#50mg/ F <ipera*uine <hosphate .+50mg/ Tablet Treatment of acute uncomplicated malaria infection due to <lasmodium viva( in adults ##.#0.,0#%