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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 40-453 DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML PACKAGED IN 1 ML SINGLE-DOSE VIALS   BEDFORD LABORATORIES 6/9/2003 
2 75-992 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML & 50 MG (BASE)/5 ML SINGLE-DOSE VIALS   ESI LEDERLE 6/10/2003 
3 76-497 LOPERAMIDE HYDROCHLORIDE TABLETS, USP (OTC) 2 MG   LNK INTERNATIONAL, INC. 6/10/2003 
4 76-270 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   ROXANE LABORATORIES, INC. 6/19/2003 
5 76-122 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   MYLAN PHARMACEUTICALS, INC. 6/19/2003 
6 76-189 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   GENEVA PHARMACEUTICALS, INC. 6/19/2003 
7 76-219 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   EON LABS, INC. 6/19/2003 
8 76-312 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   WATSON LABORATORIES, INC. 6/19/2003 
9 76-176 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   ALPHAPHARM PTY. LTD. 6/19/2003 
10 76-428 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 20 MG (BASE)/20 ML SINGLE-USE VIALS   BIONICHE (CANADA) LTD. 6/16/2003 
11 76-490 LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 450 MG   WEST-WARD PHARMACEUTICAL CORP. 6/17/2003 
12 75-880 AMINO ACID INJECTION (SULFITE-FREE) (PREMASOL INJECTION) 6% (500 ML) AND 10% (1000 & 2000 ML) VIAFLEX PLASTIC CONTAINERS   BAXTER HEALTHCARE CORPORATION 6/19/2003 
13 76-336 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   ANDRX PHARMACEUTICALS, LLC 6/20/2003 
14 76-308 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   PUREPAC PHARMACEUTICAL CO. 6/20/2003 
15 76-503 ISOTRETINOIN CAPSULES, USP 30 MG   RANBAXY LABORATORIES LIMITED 6/20/2003 
16 76-411 METHENAMINE HIPPURATE TABLETS, USP 1 GRAM   COREPHARMA LLC 6/20/2003 
17 40-435 EXTENDED PHENYTOIN SODIUM CAPSULES, USP 100 MG   BARR LABORATORIES, INC. 6/20/2003 
18 40-479 PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG AND 25 MG   PADDOCK LABORATORIES, INC. 6/24/2003 
19 76-462 METRONIDAZOLE EXTENDED-RELEASE TABLETS 750 MG   ABLE LABORATORIES, INC. 6/25/2003 
20 76-241 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   AMIDE PHARMACEUTICAL, INC. 6/25/2003 
21 76-539 VALPROATE SODIUM INJECTION 100 MG/ML   AMERICAN PHARMACEUTICAL PARTNERS, INC. 6/26/2003 
22 75-798 ALLOPURINOL TABLETS, USP 100 MG AND 300 MG   VINTAGE PHARMACEUTICALS, INC. 6/27/2003 
23 76-457 GANCICLOVIR CAPSULES 250 MG AND 500 MG   RANBAXY LABORATORIES LTD. 6/27/2003 
24 76-519 METRONIDAZOLE TABLETS, USP 250 MG AND 500 MG   ABLE LABORATORIES, INC. 6/27/2003 
25 40-500 PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG AND 25 MG   CLAY-PARK LABS, INC. 6/30/2003 
26 40-465 DICYCLOMINE HYDROCHLORIDE INJECTION, USP (PRESERVATIVE-FREE) 10 MG/ML PACKAGED IN 20 MG/2 ML SINGLE-USE VIALS   BEDFORD LABORATORIES, INC. 6/30/2003 

 

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