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First-Time Generics - June 2003

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 15 mEq UPSHER-SMITH LABORATORIES, INC. K-DUR EXTENDED-RELEASE TABLETS 6/6/2003
2 LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 450 MG WEST-WARD PHARMACEUTICAL CORP. ESKALITH CR TABLETS, 450 MG 6/17/2003
3 MIRTAZAPINE TABLETS 45 MG TEVA PHARMACEUTICALS USA REMERON TABLETS 6/19/2003
4 AMINO ACID INJECTION (SULFITE-FREE) (PREMASOL INJECTION) 6% (500 ML) AND 10% (1000 & 2000 ML) VIAFLEX PLASTIC CONTAINERS BAXTER HEALTHCARE CORPORATION TROPHAMINE INJECTION 6% AND 10% 6/19/2003
5 METHENAMINE HIPPURATE TABLETS, USP 1 GRAM COREPHARMA LLC HIPREX TABLETS 6/20/2003
6 ISOTRETINOIN CAPSULES, USP 30 MG RANBAXY LABORATORIES LIMITED ACCUTANE CAPSULES 6/20/2003
7 METRONIDAZOLE EXTENDED-RELEASE TABLETS 750 MG ABLE LABORATORIES, INC. FLAGYL ER TABLETS 6/25/2003
8 GANCICLOVIR CAPSULES 250 MG AND 500 MG RANBAXY LABORATORIES LTD. CYTOVENE CAPSULES 6/27/2003

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FDA/Center for Drug Evaluation and Research
Last Updated: July 11, 2003
Originator: OTCOM/OGD
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