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 Approved Drugs Log - First Time -November 2000


ANDA No Established Name/Dosage Form and Applicant SUB Date TA Date AP Date

74-713 CISPLATIN FOR INJECTION USP,   10 MG/VIAL, BEDFORD LABORATORIES 8/18/95 11/14/00

50 MG/VIAL

75-643 BISOPROLOL FUMARATE TABLETS,   5 MG, 10 MG EON LABS MANUFACTURING, INC. 6/4/99 11/16/00

75-619 MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% COPLEY PHARMACEUTICAL, INC. 4/16/99 11/17/00


75-518 MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% ALPHARMA 12/7/98 11/17/00


75-889 FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, MYLAN PHARMACEUTICALS, INC. 6/5/00 11/29/00

100 MG

65-060 AMOXICILLIN TABLETS, USP (CHEWABLE) 200 MG, RANBAXY LABORATORIES LIMITED 12/22/99 11/29/00

400 MG

75-888 FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, EON LABS MANUFACTURING, INC. 6/5/00 11/29/00

100 MG

Page 1 of 1

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 08:54:33 -0400
Originator: OGD
HTML by  PKS