U.S. Food and Drug Administration Center for Drug Evaluation and Research

CDER - Center for Drug Evaluation and Research Logo

Drug Information

CDER Home Site Information Comments and Feedback What's New CDER Navigation Bar

CDER ArchivesSpecific AudiencesCDER CalendarRegulatory InformationDrug InformationAbout CDERSide Navigational Buttons

Office of Generic Drugs - First Time Generics - October 2000


ANDA No Established Name/Dosage Form and Strength Applicant Submission Date Approval Date



75-466 DOXASOZIN MESYLATE TABLETS 1 MG (BASE), GENPHARM, INC. 9/28/98 10/18/00

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)

75-580 DOXAZOSIN MESYLATE TABLETS 1 MG (BASE),  TORPHARM 2/12/99 10/18/00

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)

75-426 DOXAZOSIN MESYLATE TABLETS 1 MG (BASE), CHELSEA LABORATORIES, INC. 8/3/98 10/18/00

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)

75-646 DOXAZOSIN MESYLATE TABLETS 1 MG (BASE),  EON LABS MANUFACTURING, INC. 6/10/99 10/18/00

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)

75-574 DOXAZOSIN MESYLATE TABLETS 1 MG (BASE),  PUREPAC PHARMACEUTICAL CO. 2/2/99 10/18/00

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)

75-536 DOXAZOSIN MESYLATE TABLETS 1 MG (BASE),  TEVA PHARMACEUTICALS USA 12/28/98 10/18/00

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)

75-453 DOXASOZIN MESYLATE TABLETS 1 MG (BASE), ZENITH GOLDLINE 12/30/98 10/18/00

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)

75-203 PROPAFENONE HYDROCHLORIDE TABLETS, 150 MG, WATSON LABORATORIES, INC. 9/15/97 10/24/00

 


totop.gif (1525 bytes) Back to Top   Back Back to Approvals

FDA/Center for Drug Evaluation and Research
Last Updated: September 10, 200125 Apr 2006 08:54:31 -0400
Originator: OGD
HTML by  PKS