Tentative Approvals - August 2003

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FDA/Center for Drug Evaluation and Research

ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 75-435 GABAPENTIN CAPSULES 100 MG 300 MG 400 MG TEVA PHARMACEUTICALS USA 8/7/2003

2 75-808 NORGESTIMATE & ETHINYL ESTRADIOL TABLETS, USP 0.180 MG/0.035 MG, 0.215 MG/0.035 MG, 0.250 MG/0.035 MG; 28-DAY CYCLE REGIMEN BARR LABORATORIES, INC 8/20/2003

3 76-159 GLIPIZIDE EXTENDED-RELEASE TABLETS 10 MG ANDRX PHARMACEUTICALS, LLC 8/22/2003

4 76-206 CALCITRIOL INJECTION 0.001 MG/ML (1 MCG/ML) LYNE LABORATORIES, INC. 8/22/2003

Date created: 9/4/2003