Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • 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 Number Generic Drug Name Applicant Tentative Approval Date
1 76-558 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   HIKMA PHARMACEUTICALS 3/2/2004 
2 76-509 FENOFIBRATE TABLETS 54 MG AND 160 MG   IMPAX LABORATORIES, INC. 3/5/2004 
3 76-433 FENOFIBRATE TABLETS 54 MG AND 160 MG   TEVA PHARMACEUTICALS USA 3/5/2004 
4 76-459 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   AMIDE PHARMACEUTICAL, INC. 3/9/2004 
5 76-607 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   RANBAXY LABORATORIES LIMITED 3/12/2004 
6 76-657 IFOSFAMIDE INJECTION 50 MG/ML; PACKAGED IN 1 G/20 ML AND 3 G/60 ML SINGLE-DOSE VIALS   SICOR PHARMACEUTICALS, INC. 3/17/2004 
7 76-077 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG   IVAX PHARMACEUTICALS, INC. 3/17/2004 
8 76-642 HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MG   INTERPHARM, INC. 3/18/2004 
9 76-517 CARBOPLATIN 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 
10 76-288 RISPERIDONE TABLETS 0.25 MG, 0.5 MG, 1 MG, 2 MG, 3 MG, AND 4 MG   MYLAN PHARMACEUTICALS, INC. 3/31/200
-
-