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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-080AMOXICILLIN TABLETS FOR ORAL SUSPENSION 200 MG AND 400 MG  RANBAXY LABORATORIES LIMITED8/11/2003 
276-134LORATADINE TABLETS (OTC) 10 MG  RANBAXY LABORATORIES LIMITED8/18/2003 
376-453LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5%  ALTANA INC.8/18/2003 
476-154LORATADINE TABLETS (OTC) 10 MG  GENPHARM INC.8/20/2003 
565-083CEFPODOXIME PROXETIL TABLETS 100 MG (BASE) AND 200 MG (BASE)  RANBAXY LABORATORIES, INC.8/20/2003 
676-546TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES, USP 300 MG  AMIDE PHARMACEUTICAL, INC.8/20/2003 
776-366LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 450 MG  BARR LABORATORIES, INC.8/21/2003 
876-528BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOSPHATE CAPS 50 MG/325 MG/40 MG/30 MG  ABLE LABORATORIES, INC.8/21/2003 
940-481DIGOXIN INJECTION, USP 0.25 MG/ML; PACKAGED IN 0.5 MG/2 ML AMPULES  SABEX 2002 INC.8/21/2003 
1075-715FAMOTIDINE TABLETS (CHEWABLE) (OTC) 10 MG  L. PERRIGO COMPANY8/22/2003 
1176-544NAPROXEN SODIUM TABLETS, USP 275 MG (250 MG BASE) AND 550 MG (500 MG BASE)  ABLE LABORATORIES, INC.8/22/2003 
1240-513BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 MG/500 MG/40 MG  VINTAGE PHARMACEUTICALS, INC.8/25/2003 
1376-214SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG, 120 MG, AND 160 MG  TORPHARM8/27/2003 
1476-320LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5%  ATRIX LABORATORIES, INC.8/27/2003 
1540-511BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/325 MG/40 MG  VINTAGE PHARMACEUTICALS, INC.8/27/2003 
1676-570TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES, USP 300 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.8/28/2003 
1776-349FLUDARABINE PHOSPHATE FOR INJECTION, USP 50 MG/SINGLE-DOSE VIAL  SICOR PHARMACEUTICALS8/28/2003 
1876-234FLAVOXATE HYDROCHLORIDE TABLETS 100 MG  IMPAX LABORATORIES, INC.8/28/2003 
1940-516CHLOROQUINE PHOSPHATE TABLETS, USP 500 MG (300 MG BASE)  IMPAX LABORATORIES, INC.8/29/2003 
2040-508HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 10 MG/500 MG PER 15 ML  MALLINCKRODT INC.8/29/2003