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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 65-080 AMOXICILLIN TABLETS FOR ORAL SUSPENSION 200 MG AND 400 MG   RANBAXY LABORATORIES LIMITED 8/11/2003 
2 76-134 LORATADINE TABLETS (OTC) 10 MG   RANBAXY LABORATORIES LIMITED 8/18/2003 
3 76-453 LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5%   ALTANA INC. 8/18/2003 
4 76-154 LORATADINE TABLETS (OTC) 10 MG   GENPHARM INC. 8/20/2003 
5 65-083 CEFPODOXIME PROXETIL TABLETS 100 MG (BASE) AND 200 MG (BASE)   RANBAXY LABORATORIES, INC. 8/20/2003 
6 76-546 TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES, USP 300 MG   AMIDE PHARMACEUTICAL, INC. 8/20/2003 
7 76-366 LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 450 MG   BARR LABORATORIES, INC. 8/21/2003 
8 76-528 BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOSPHATE CAPS 50 MG/325 MG/40 MG/30 MG   ABLE LABORATORIES, INC. 8/21/2003 
9 40-481 DIGOXIN INJECTION, USP 0.25 MG/ML; PACKAGED IN 0.5 MG/2 ML AMPULES   SABEX 2002 INC. 8/21/2003 
10 75-715 FAMOTIDINE TABLETS (CHEWABLE) (OTC) 10 MG   L. PERRIGO COMPANY 8/22/2003 
11 76-544 NAPROXEN SODIUM TABLETS, USP 275 MG (250 MG BASE) AND 550 MG (500 MG BASE)   ABLE LABORATORIES, INC. 8/22/2003 
12 40-513 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 MG/500 MG/40 MG   VINTAGE PHARMACEUTICALS, INC. 8/25/2003 
13 76-214 SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG, 120 MG, AND 160 MG   TORPHARM 8/27/2003 
14 76-320 LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5%   ATRIX LABORATORIES, INC. 8/27/2003 
15 40-511 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/325 MG/40 MG   VINTAGE PHARMACEUTICALS, INC. 8/27/2003 
16 76-570 TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES, USP 300 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 8/28/2003 
17 76-349 FLUDARABINE PHOSPHATE FOR INJECTION, USP 50 MG/SINGLE-DOSE VIAL   SICOR PHARMACEUTICALS 8/28/2003 
18 76-234 FLAVOXATE HYDROCHLORIDE TABLETS 100 MG   IMPAX LABORATORIES, INC. 8/28/2003 
19 40-516 CHLOROQUINE PHOSPHATE TABLETS, USP 500 MG (300 MG BASE)   IMPAX LABORATORIES, INC. 8/29/2003 
20 40-508 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 10 MG/500 MG PER 15 ML   MALLINCKRODT INC. 8/29/2003 

 

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