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 - August 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-011 ONDANSETRON INJECTION USP (PRESERVATIVE-FREE) 2 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/2 ML SINGLE-DOSE VIALS   BEDFORD LABORATORIES 8/11/2004 
2 76-967 ONDANSETRON INJECTION, USP 2 MG (BASE)/ML, PACKAGED IN 40 MG (BASE)/20 ML MULTIPLE-DOSE VIALS   BEDFORD LABORATORIES 8/11/2004 
3 76-671 SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   MYLAN PHARMACEUTICALS INC. 8/12/2004 
4 76-677 CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10 MG   MYLAN PHARMACEUTICALS, INC. 8/20/2004 
5 76-606 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG   RANBAXY LABORATORIES LIMITED 8/25/2004 
6 76-693 ONDANSETRON ORALLY DISINTEGRATING TABLETS 4 MG AND 8 MG   BARR LABORATORIES, INC. 8/26/2004 

 

-
-