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 - July 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 75-416 NAPROXEN SODIUM EXTENDED-RELEASE TABLETS 375 MG (BASE) ANDRX PHARMACEUTICALS, INC. 7/5/01
2 75-794 ACETAMINOPHEN, ASPIRIN, AND CAFFEINE TABLETS 250 MG/250 MG/65 MG PERRIGO COMPANY 7/12/01
3 75-300 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG GENEVA PHARMACEUTICALS, INC. 7/18/01
4 75-451 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG MYLAN PHARMACEUTICALS, INC. 7/18/01
5 75-551 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG TEVA PHARMACEUTICALS USA 7/18/01
6 75-636 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG EON LABS MANUFACTURING, INC. 7/18/01
7 75-685 CIPROFLOXACIN TABLETS, USP 250 MG, AND 500 MG (NOTE: 750 MG STRENGTH WAS PREVIOUSLY T/A'ED) MYLAN PHARMACEUTICALS, INC. 7/18/01
8 75-935 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG GENPHARM INC. 7/18/01
9 75-565 LORATADINE SYRUP 10 MG/10 ML NOVEX PHARMA 7/30/01
10 75-882 FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG BARR LABORATORIES, INC. 7/31/01

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

FDA/Center for Drug Evaluation and Research
Last Updated: August 15, 200125 Apr 2006 08:49:29 -0400
Originator: OGC
HTML by PKS, TA