• 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 - October 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-878METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG  PUREPAC PHARMACEUTICAL COMPANY10/4/2004 
276-221NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1 MG/0.005 MG  BARR LABORATORIES, INC.10/5/2004 
376-912CIPROFLOXACIN TABLETS, USP 100 MG  TARO PHARMACEUTICAL INDUSTRIES LTD.10/6/2004 
476-047CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10 MG PAR PHARMACEUTICAL, INC.10/6/2004 
576-873METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  EON LABS MANUFACTURING, INC.10/13/2004 
676-436FINASTERIDE TABLETS, USP 1 MG  DR. REDDY'S LABORATORIES LIMITED10/14/2004 
775-485GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MGWATSON LABORATORIES, INC.10/18/2004 
876-989CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG  RANBAXY LABORATORIES LIMITED10/22/2004 
976-511FINASTERIDE TABLETS, USP 5 MG  TEVA PHARMACEUTICALS USA10/26/2004 
1076-744TESTOSTERONE GEL 1%  PADDOCK LABORATORIES, INC.10/27/2004