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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-453DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML PACKAGED IN 1 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES6/9/2003 
275-992VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML & 50 MG (BASE)/5 ML SINGLE-DOSE VIALS  ESI LEDERLE6/10/2003 
376-497LOPERAMIDE HYDROCHLORIDE TABLETS, USP (OTC) 2 MG  LNK INTERNATIONAL, INC.6/10/2003 
476-270MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  ROXANE LABORATORIES, INC.6/19/2003 
576-122MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  MYLAN PHARMACEUTICALS, INC.6/19/2003 
676-189MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  GENEVA PHARMACEUTICALS, INC.6/19/2003 
776-219MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  EON LABS, INC.6/19/2003 
876-312MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  WATSON LABORATORIES, INC.6/19/2003 
976-176MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  ALPHAPHARM PTY. LTD.6/19/2003 
1076-428MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 20 MG (BASE)/20 ML SINGLE-USE VIALS  BIONICHE (CANADA) LTD.6/16/2003 
1176-490LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 450 MG  WEST-WARD PHARMACEUTICAL CORP.6/17/2003 
1275-880AMINO ACID INJECTION (SULFITE-FREE) (PREMASOL INJECTION) 6% (500 ML) AND 10% (1000 & 2000 ML) VIAFLEX PLASTIC CONTAINERS  BAXTER HEALTHCARE CORPORATION6/19/2003 
1376-336MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  ANDRX PHARMACEUTICALS, LLC6/20/2003 
1476-308MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  PUREPAC PHARMACEUTICAL CO.6/20/2003 
1576-503ISOTRETINOIN CAPSULES, USP 30 MG  RANBAXY LABORATORIES LIMITED6/20/2003 
1676-411METHENAMINE HIPPURATE TABLETS, USP 1 GRAM  COREPHARMA LLC6/20/2003 
1740-435EXTENDED PHENYTOIN SODIUM CAPSULES, USP 100 MG  BARR LABORATORIES, INC.6/20/2003 
1840-479PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG AND 25 MG  PADDOCK LABORATORIES, INC.6/24/2003 
1976-462METRONIDAZOLE EXTENDED-RELEASE TABLETS 750 MG  ABLE LABORATORIES, INC.6/25/2003 
2076-241MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  AMIDE PHARMACEUTICAL, INC.6/25/2003 
2176-539VALPROATE SODIUM INJECTION 100 MG/ML  AMERICAN PHARMACEUTICAL PARTNERS, INC.6/26/2003 
2275-798ALLOPURINOL TABLETS, USP 100 MG AND 300 MG  VINTAGE PHARMACEUTICALS, INC.6/27/2003 
2376-457GANCICLOVIR CAPSULES 250 MG AND 500 MG  RANBAXY LABORATORIES LTD.6/27/2003 
2476-519METRONIDAZOLE TABLETS, USP 250 MG AND 500 MG  ABLE LABORATORIES, INC.6/27/2003 
2540-500PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG AND 25 MG  CLAY-PARK LABS, INC.6/30/2003 
2640-465DICYCLOMINE HYDROCHLORIDE INJECTION, USP (PRESERVATIVE-FREE) 10 MG/ML PACKAGED IN 20 MG/2 ML SINGLE-USE VIALS  BEDFORD LABORATORIES, INC.6/30/2003