• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

First-Time Generic Drug Approvals - January 2014

 Generic Drug NameGeneric ManufacturerBrand NameTentative Approval DateApproval Date
1LAMIVUDINE TABLETS (HBV) 100 MG       HETERO LABS LIMITED UNIT VEPIVIR-HBV 1/2/2014 
2LAMIVUDINE TABLETS (HBV), 100 MG       APOTEX CORP.EPIVIR-HBV TABLETS 1/2/2014 
3TELMISARTAN TABLETS USP, 20 MG, 40 MG AND 80 MG     WATSON LABORATORIES, INC.MICARDIS TABLETS 1/7/2014 
4TELMISARTAN AND AMLODIPINE TABLETS, 40 MG/5 MG, 40 MG/10 MG, 80 MG/5 MG AND 80 MG/10 MG    TORRENT PHARMACEUTICALS LIMITEDTWYNSTA TABLETS 1/8/2014 
5SIROLIMUS TABLETS 0.5 MG       ZYDUS PHARMACEUTICALS (USA) INC.RAPAMUNE TABLETS, 0.5 MG 1/8/2014 
6MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS, 180 MG AND 360 MG      MYLAN PHARMACEUTICALS, INC.MYFORTIC DELAYED-RELEASE TABLETS 1/8/2014 
7TELMISARTAN AND AMLODIPINE TABLETS, 40 MG/5 MG, 40 MG/10 MG, 80 MG/5 MG AND 80 MG/10 MG    LUPIN LIMITEDTWYNSTA TABLETS 1/8/2014 
8DOXERCALCIFEROL CAPSULES, 1 MCG AND 2.5 MCG      ROXANE LABORATORIES, INC.HECTOROL CAPSULES 1/14/2014 
9FLUOCINONIDE CREAM USP, 0.1%       PERRIGO ISRAEL PHARMACEUTICALS, LTD.VANOS CREAM 1/14/2014 
10BROMFENAC OPHTHALMIC SOLUTION, 0.09% (ONCE-A-DAY)       HI-TECH PHARMACAL CO., INC.BROMDAY OPHTHALMIC SOLUTION 1/22/2014 
11REPAGLINIDE TABLETS USP, 1 MG AND 2 MG      PADDOCK LABORATORIES, LLCPRANDIN TABLETS, 1 MG AND 2 MG 1/22/2014 
12REPAGLINIDE TABLETS USP, 1 MG AND 2 MG      SANDOZ INC.PRANDIN TABLETS, 1 MG AND 2 MG 1/22/2014 
13REPAGLINIDE TABLETS USP, 1 MG AND 2 MG      ACTAVIS TOTOWA LLCPRANDIN TABLETS, 1 MG AND 2 MG 1/22/2014 
14REPAGLINIDE TABLETS USP, 1 MG AND 2 MG      MYLAN PHARMACEUTICALS INC.PRANDINTABLETS, 1 MG AND 2 MG 1/22/2014 
15REPAGLINIDE TABLETS USP, 0.5 MG, 1 MG AND 2 MG     AUROBINDO PHARMA LTD.PRANDIN TABLETS 1/22/2014 
16SUNITINIB MALEATE CAPSULES, 12.5 MG (BASE), 25 MG (BASE), 37.5 MG (BASE) AND 50 MG (BASE)    MYLAN PHARMACEUTICALS, INC.SUTENT CAPSULES 1/30/2014