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U.S. Department of Health and Human Services

Drugs

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Approvals - November 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-085MUPIROCIN OINTMENT, USP 2%  TEVA PHARMACEUTICALS USA11/7/2003 
276-526FLUOROURACIL TOPICAL SOLUTION, USP 2% AND 5%  TARO PHARMACEUTICAL INDUSTRIES LTD.11/5/2003 
375-990LORATADINE ORALLY DISINTEGRATING TABLETS 10 MG  ANDRX PHARMACEUTICALS, LLC11/3/2003 
476-478IBUPROFEN/PSEUDOEPHEDRINE HYDROCHLORIDE ORAL SUSPENSION 100 MG/15 MG PER 5 ML, BERRY, GRAPE, AND BUBBLE GUM FLAVORS  PERRIGO COMPANY11/5/2003 
576-598IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.06% (0.042 MG/SPRAY)  ROXANE LABORATORIES, INC.11/5/2003 
676-664IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY)  ROXANE LABORATORIES, INC.11/5/2003 
775-505LORATADINE SYRUP 5 MG/5 ML  TEVA PHARMACEUTICALS USA11/7/2003 
865-114PIPERACILLIN FOR INJECTION, USP 2 G, 3 G, AND 4 G PACKAGED IN SINGLE-USE VIALS  ISTITUTO BIOCHIMICO ITALIANO, S.P.A.11/14/2003 
976-258FENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75mcg/hr, AND 100 mcg/hr  MYLAN TECHNOLOGIES, INC.11/21/2003 
1076-370ALBUTEROL SULFATE INHALATION SOLUTION 0.083%  BREATH LIMITED11/24/2003 
1175-932BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 100 MG  EON LABS, INC.11/25/2003 
1276-139FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  TEVA PHARMACEUTICALS USA11/25/2003 
1376-460IBUPROFEN TABLETS, USP (OTC) 200 MG  NEIL LABORATORIES, INC.11/26/2003 
1475-563SOTALOL HYDROCHLORIDE TABLETS 80 MG, 120 MG, 160 MG, AND 240 MG  VINTAGE PHARMACEUTICALS, INC.11/7/2003 
1565-123MUPIROCIN OINTMENT, USP 2%  CLAY-PARK LABS, INC.11/7/2003 
1676-505METRONIDAZOLE CAPSULES 375 MG  ABLE LABORATORIES, INC.11/13/2003 
1776-481MOMETASONE FUROATE OINTMENT, USP 0.1%  ATRIX LABORATORIES, INC.11/14/2003