• 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 - May 2014

 Generic Drug NameGeneric ManufacturerBrand NameTentative Approval DateApproval Date
1ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE TABLETS, 2 MG (BASE)/500 MG, 4 MG (BASE)/500 MG, 2 MG (BASE)/1 GRAM AND 4 MG (BASE)/1 GRAM    TEVA PHARMACEUTICALS USA, INC.AVANDAMET TABLETS 5/7/2014 
2BUDESONIDE NASAL SPRAY, 32 MCG/SPRAY; PACKAGED IN 120 METERED SPRAY CONTAINERS     APOTEX CORPRHINOCORT AQUA 5/12/2014 
3HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (ONCE DAILY). 8 MG, 12 MG AND 16 MG     ACTAVIS LABORATORIES FL, INC.EXALGO EXTENDED-RELEASE TABLETS 5/12/2014 
4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS, 62.5 MG/25 MG AND 200 MG/100 MG      MYLAN PHARMACEUTICALS, INC.MALARONE TABLETS 5/27/2014 
5DICLOFENAC SODIUM TOPICAL SOLUTION, 1.5% W/W       APOTEX CORP.PENNSAID TOPICAL SOLUTION 5/27/2014 
6CELECOXIB CAPSULES, 50 MG       MYLAN PHARMACEUTICALS, INC.CELEBREX CAPSULES 5/30/2014 
7CELECOXIB CAPSULES, 50 MG, 100 MG, 200 MG AND 400 MG    TEVA PHARMACEUTICALS USACELEBREX CAPSULES 5/30/2014