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

Drugs

  • Print
  • Share
  • E-mail

Tentative Approvals - March 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-520FENOFIBRATE TABLETS 54 MG, 107 MG, AND 160 MG  PAR PHARMACEUTICAL3/3/2005 
276-575TOPIRAMATE CAPSULES 15 MG AND 25 MG  TEVA PHARMACEUTICALS USA3/9/2005 
377-065TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)  GEDEON RICHTER LTD.3/10/2005 
476-799PIOGLITAZONE HYDROCHLORIDE TABLETS 15 MG (BASE), 30 MG (BASE), AND 45 MG (BASE)  ALPHAPHARM PTY, LTD.3/15/2005 
576-415OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG  TEVA PHARMACEUTICALS USA3/24/2005 
676-846AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)  TEVA PHARMACEUTICALS USA3/24/2005 
776-866OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG  MYLAN PHARMACEUTICALS INC.3/25/2005 
876-826LEVOFLOXACIN OPHTHALMIC SOLUTION 0.5%  HI-TECH PHARMACAL CO., INC.3/28/2005 
975-959OCTREOTIDE ACETATE INJECTION (MULTIPLE DOSE VIALS) 0.2 MG/ML AND 1.0 MG/ML  SICOR PHARMACEUTICALS, INC.3/28/2005 
1075-957OCTREOTIDE ACETATE INJECTION 0.05 MG/ML, 0.1 MG/ML, AND 0.5 MG/ML  SICOR PHARMACEUTICALS, INC.3/28/2005 
1176-904RISPERIDONE ORAL SOLUTION 1 MG/ML  ROXANE LABORATORIES, INC.3/30/2005