First Time Generics - February 2003

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FDA/Center for Drug Evaluation and Research

First-Time Generics - February 2003

	Generic Drug Name	Generic Manufacturer	Brand Name	Approval Date
1	VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG/ML AND 50 MG/5 ML SINGLE-DOSE VIALS	GENSIA SICOR PHARMACEUTICALS, INC.	NAVELBINE INJECTION	2/3/03
2	AZATHIOPRINE TABLETS, USP 75 MG AND 100 MG (ADDITIONAL STRENGTHS)	aaiPHARMA, INC.	IMURAN TABLETS	2/3/03
3	LORATADINE ORALLY DISINTEGRATING TABLETS (OTC) 10 MG	WYETH CONSUMER HEALTHCARE	CLARITIN REDITABS	2/10/03
4	TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE)	ROXANE LABORATORIES, INC.	NOLVADEX TABLETS	2/20/03
5	LORATADINE & PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLET 10 MG/240 MG (24-HOUR FORMULATION) (OTC)	ANDRX PHARMACEUTICALS, L.L.C.	CLARITIN-D 24-HOUR EXTENDED-RELEASE TABLETS	2/21/03

Date created: March 7, 2003