U.S. Food and Drug Administration • Center for Drug Evaluation and ResearchSkip navigation
CDER - Center for Drug Evaluation and Research Logo

Drug Information

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

Tentative Approvals - February 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-213 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG ROXANE LABORATORIES, INC. 2/11/03
2 76-241 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG AMIDE PHARMACEUTICAL, INC. 2/12/03
3 76-208 LORATADINE & PSEUDOPEHEDRINE SULFATE EXTENDED-RELEASE TABLET 5 MG/120 MG (12-HOUR FORMULATION) (OTC) ANDRX PHARMACEUTICALS L.L.C. 2/24/03
4 76-267 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG ANDRX PHARMACEUTICALS L.L.C. 2/26/03
5 76-344 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG RANBAXY LABORATORIES LIMITED 2/26/03
6 76-402 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG EON LABS, INC. 2/26/03
7 76-300 FLUTICASONE PROPIONATE OINTMENT 0.005% ALTANA INC. 2/27/03
8 75-276 BETAMETHASONE DIPROPIONATE GEL (AUGMENTED) 0.05% (BASE) ALTANA INC. 2/28/03

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

FDA/Center for Drug Evaluation and Research
Last Updated: March 7, 2003
Originator: OTCOM/DLIS
HTML by SJW