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Drugs

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Tentative Approvals - June 2003

	ANDA Number	Generic Drug Name	Applicant	Tentative Approval Date
1	76-039	CARBOPLATIN INJECTION 10 MG/ML	BEDFORD LABORATORIES	6/6/2003
2	76-086	FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG	GENEVA PHARMACEUTICALS, INC.	6/10/2003
3	75-763	NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG	IVAX PHARMACEUTICALS, INC.	6/11/2003
4	40-486	METAXALONE TABLETS 400 MG	COREPHARMA LLC	6/11/2003
5	76-049	QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)	ANDRX PHARMACEUTICALS, LLC	6/11/2003
6	76-378	NIACIN EXTENDED-RELEASE TABLETS 500 MG, AND 750 MG	BARR LABORATORIES, INC.	6/13/2003
7	76-220	OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG	RANBAXY LABORATORIES LIMITED	6/17/2003
8	76-304	FLUCONAZOLE INJECTION (IN 5% DEXTROSE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS	ABBOTT LABORATORIES	6/18/2003
9	76-303	FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS	ABBOTT LABORATORIES	6/18/2003
10	76-456	ESMOLOL HYDROCHLORIDE CONCENTRATE 250 MG/ML, PACKAGED IN 2500 MG/10 ML AMPULES FOR DILUTION	PHARMAFORCE, INC.	6/26/2003
11	76-474	ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML, PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS	PHARMAFORCE, INC.	6/26/2003
12	76-397	PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG	LEK PHARMACEUTICALS D.D.	6/26/2003
13	76-326	ESMOLOL HYDROCHLORIDE CONCENTRATE 250 MG/ML, PACKAGED IN 2,500 MG/10 ML VIALS FOR DILUTION	BEDFORD LABORATORIES	6/26/2003
14	76-323	ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML, PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS	BEDFORD LABORATORIES	6/26/2003

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