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 - April 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 75-588 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG/30 MG PHARMACEUTICAL FORMULATIONS, INC. 4/17/01
2 75-788 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG; AND 10 MG/25 MG TARO PHARMACEUTICAL INDUSTRIES, LTD. 4/18/01
3 75-869 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG; 20 MG/12.5 MG; AND 20 MG/25 MG TEVA PHARMACEUTICALS USA 4/18/01

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 08:48:27 -0400
Originator: OGC
HTML by PKS, TA