• 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 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-558CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  HIKMA PHARMACEUTICALS3/2/2004 
276-509FENOFIBRATE TABLETS 54 MG AND 160 MG  IMPAX LABORATORIES, INC.3/5/2004 
376-433FENOFIBRATE TABLETS 54 MG AND 160 MG  TEVA PHARMACEUTICALS USA3/5/2004 
476-459QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  AMIDE PHARMACEUTICAL, INC.3/9/2004 
576-607QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  RANBAXY LABORATORIES LIMITED3/12/2004 
676-657IFOSFAMIDE INJECTION 50 MG/ML; PACKAGED IN 1 G/20 ML AND 3 G/60 ML SINGLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.3/17/2004 
776-077FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  IVAX PHARMACEUTICALS, INC.3/17/2004 
876-642HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MG  INTERPHARM, INC.3/18/2004 
976-517CARBOPLATIN INJECTION 10 MG/ML, PACKAGED IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML SINGLE-DOSE VIALS  MAYNE PHARMA (USA) INC.3/30/2004 
1076-288RISPERIDONE TABLETS 0.25 MG, 0.5 MG, 1 MG, 2 MG, 3 MG, AND 4 MG  MYLAN PHARMACEUTICALS, INC.3/31/200