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U.S. Department of Health and Human Services

Drugs

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Approvals - March 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-856DANTROLENE SODIUM CAPSULES 25 MG, 50 MG, AND 100 MG  IMPAX LABORATORTIES, INC.3/1/2005 
276-943TORSEMIDE TABLETS 5 MG, 10 MG, AND 20 MG  ROXANE LABORATORIES, INC.3/1/2005 
377-020CILOSTAZOL TABLETS 100 MG  IVAX PHARMACEUTICALS, INC.3/1/2005 
465-200GRISEOFULVIN ORAL SUSPENSION, USP 125 MG/5 ML  STIEFEL LABORATORIES, INC.3/2/2005 
574-777RANITIDINE INJECTION, USP 25 MG/ML; PACKAGED IN 50 MG/2 ML VIALS  BEN VENUE LABORATORIES, INC.3/2/2005 
676-773MICONAZOLE NITRATE VAGINAL CREAM (3-DAY TREATMENT) (OTC) 4%  TARO PHARMACEUTICALS U.S.A., INC.3/2/2005 
776-803QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  EON LABS, INC.3/2/2005 
876-931BUPRENORPHINE HYDROCHLORIDE INJECTION 0.3 MG (BASE)/ML  BEDFORD LABORATORIES3/2/2005 
977-146FAMOTIDINE TABLETS, USP (OTC) 10 MG  WOCKHARDT LIMITED3/7/2005 
1065-195CLARITHROMYCIN TABLETS, USP 250 MG AND 500 MG  GENPHARM INC.3/11/2005 
1177-150CILOSTAZOL TABLETS 50 MG  COREPHARMA, LLC3/11/2005 
1275-400FAMOTIDINE TABLETS, USP (OTC) 10 MG  L. PERRIGO COMPANY3/18/2005 
1376-959CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS  EON LABS, INC.3/18/2005 
1475-477GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  IVAX PHARMACEUTICALS, INC.3/23/2005 
1540-169DICYCLOMINE HYDROCHLORIDE SYRUP, USP 10 MG/5 ML  MIKART, INC.3/24/2005 
1665-078CYCLOSPORINE ORAL SOLUTION, USP (MODIFIED) 100 MG/ML  IVAX PHARMACEUTICALS S.R.O.3/25/2005 
1776-888FLUCONAZOLE INJECTION (IN 5% DEXTROSE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS  APOTEX CORP.3/25/2005 
1876-889FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS  APOTEX CORP.3/25/2005 
1977-152TERBUTALINE SULFATE TABLETS, USP 2.5 MG AND 5 MG  LANNETT HOLDINGS, INC.3/25/2005 
2076-313OCTREOTIDE ACETATE INJECTION (PRESERVATIVE FREE) 0.05 MG/ML, 0.1 MG/ML, AND 0.5 MG/ML  BEFORD LABORATORIES3/28/2005 
2177-061MOMETASONE FUROATE OINTMENT, USP 0.1%  ALTANA INC.3/28/2005 
2277-093QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 10 MG (BASE)/12.5 MG, 20 MG (BASE)/12.5 MG, AND 20 MG (BASE)/25 MG  MYLAN PHARMACEUTICALS, INC.3/28/2005 
2365-110CYCLOSPORINE CAPSULES USP (MODIFIED) 25 MG, 50 MG, AND 100 MG  IVAX PHARMACEUTICALS S.R.O.3/29/2005 
2476-951NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULES 100 MG  RANBAXY LABORATORIES LIMITED3/30/2005