First-Time Generics

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FDA/Center for Drug Evaluation and Research

First-Time Generics - July 2003

	Generic Drug Name	Generic Manufacturer	Brand Name	Approval Date
1	GANCICLOVIR SODIUM FOR INJECTION 500 MG (BASE)/VIAL	BEDFORD LABORATORIES	CYTOVENE-IV FOR INJECTION	7/16/2003
2	CALCITRIOL ORAL SOLUTION 1 MCG/ML	ROXANE LABORATORIES, INC.	ROCALTROL ORAL SOLUTION	7/18/2003
3	PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE)	TORPHARM	PAXIL TABLETS	7/30/2003
4	CLOZAPINE TABLETS 12.5 MG (NEW STRENGTH)	IVAX PHARMACEUTICALS, INC.	CLOZARIL TABLETS	7/31/2003

Date created: 8/7/2003