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U.S. Department of Health and Human Services

Drugs

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Approvals - February 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-491POLYETHYLENE GLYCOL 3350, KCL, NaHCO3 & NACL FOR ORAL SOLUT 420 G, 1.48 G, 5.72 G, AND 11.2 G, RESPECTIVELY PER BOTTLE  SCHWARZ PHARMA, INC.2/5/2004 
265-088NEOMYCIN & POLYMYXIN B SULFATES, & BACITRACIN ZN OPHTHAL OIN 3.5 MG (BASE), 10,000 UNITS, AND 400 UNITS, RESPECTIVELY, PER GRAM  AKORN, INC.2/6/2004 
376-636OXYCODONE HYDROCHLORIDE TABLETS, USP 15 MG, AND 30 MG  AMIDE PHARMACEUTICAL, INC.2/6/2004 
476-118BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  KV PHARMACEUTICAL COMPANY2/11/2004 
576-402BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  EON LABS, INC.2/11/2004 
676-267BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  ANDRX PHARMACEUTICALS, LLC2/11/2004 
776-333BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  IVAX PHARMACEUTICALS, INC.2/11/2004 
876-430BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  MYLAN PHARMACEUTICALS, INC.2/11/2004 
976-211BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  TEVA PHARMACEUTICALS USA2/11/2004 
1040-461MERCAPTOPURINE TABLETS, USP 50 MG  PROMETHEUS LABORATORIES, INC.2/11/2004 
1176-476BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  GENPHARM, INC.2/11/2004 
1276-348BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG  IVAX PHARMACEUTICALS, INC.2/11/2004 
1376-612BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG  GENPHARM, INC.2/11/2004 
1465-130CEFIXIME TABLETS, USP 400 MG  LUPIN LIMITED2/12/2004 
1540-528MERCAPTOPURINE TABLETS, USP 50 MG  ROXANE LABORATORIES2/13/2004 
1676-345GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG  IVAX PHARMACEUTICALS, INC.2/18/2004 
1765-129CEFIXIME FOR ORAL SUSPENSION, USP 100 MG/5 ML  LUPIN LIMITED2/23/2004 
1876-455DESOGESTREL AND ETHINYL ESTRADIOL TABLETS 0.10 MG/0.025 MG, 0.125 MG/0.025 MG, 0.15 MG/0.025 MG; 28-DAY TRIPHASIC REGIMEN  BARR LABORATORIES, INC.2/24/2004 
1940-529METHAMPHETAMINE HYDROCHLORIDE TABLETS, USP 5 MG  ABLE LABORATORIES2/25/2004 
2076-342BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG  ANDRX PHARMACEUTICALS, LLC2/11/2004 
2176-344BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  RANBAXY LABORATORIES LIMITED2/11/2004 
2276-631BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG  EON LABS, INC.2/11/2004 
2376-688BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG  MYLAN PHARMACEUTICALS, INC.2/11/2004