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U.S. Department of Health and Human Services

Drugs

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Approvals - November 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-721BETHANECHOL CHLORIDE TABLETS USP, 50 MG  IMPAX LABORATORIES, INC.11/1/2006 
240-739BETHANECHOL CHLORIDE TABLETS USP, 5 MG  IMPAX LABORATORIES, INC.11/1/2006 
340-740BETHANECHOL CHLORIDE TABLETS USP, 25 MG  IMPAX LABORATORIES, INC.11/1/2006 
440-741BETHANECHOL CHLORIDE TABLETS USP, 10 MG  IMPAX LABORATORIES, INC.11/1/2006 
577-723HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS, 7.5 MG/200 MG AND 10 MG/200 MG  VINTAGE PHARMACEUTICALS, LLC11/6/2006 
677-727HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS, 5 MG/200 MG  VINTAGE PHARMACEUTICALS, LLC11/6/2006 
765-377DOXYCYCLINE TABLETS, 50 MG, 75 MG, AND 100 MG  MYLAN PHARMACEUTICALS, INC.11/7/2006 
878-102MELOXICAM TABLETS, 7.5 MG AND 15 MG  TARO PHARMACEUTICAL INDUSTRIES, LTD.11/7/2006 
940-593PROMETHAZINE HYDROCHLORIDE INJECTION USP, 25 MG/ML AND 50 MG/ML; 1 ML AMPULES  SANDOZ CANADA, INC.11/8/2006 
1076-644OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS, 10 MG  MYLAN PHARMACEUTICALS, INC.11/9/2006 
1176-702OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS, 5 MG  MYLAN PHARMACEUTICALS INC.11/9/2006 
1276-745OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS, 15 MG  IMPAX LABORATORIES, INC.11/9/2006 
1377-698THALLOUS CHLORIDE Tl-201 INJECTION USP, 2 mCi/mL  TCI MEDICAL, INC.11/9/2006 
1477-612SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION USP, 200 MG/40 MG PER 5 ML  TEVA PHARMACEUTICALS USA11/13/2006 
1577-015SULFACETAMIDE SODIUM TOPICAL SUSPENSION USP, 10%  ALTANA INC.11/17/2006 
1677-730PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 30 MG, AND 40 MG  PLIVA HRVATSKA d.o.o.11/21/2006 
1776-759ONDANSETRON INJECTION USP, 2 MG/ML (PRESERVATIVE-FREE); 2ML VIALS  TEVA PHARMACEUTICALS USA11/22/2006 
1876-876ONDANSETRON INJECTION USP, 2 MG/ML; 40 ML VIALS  TEVA PHARMACEUTICALS USA11/22/2006 
1977-480ONDANSETRON AND DEXTROSE INJECTION, 0.64 MG/ML, 50 ML FLEXIBLE PLASTIC CONTAINERS  SICOR PHARMACEUTICALS, INC.11/22/2006 
2065-314AMPICILLIN AND SULBACTAM FOR INJECTION USP, 10 GRAMS (BASE)/5 GRAMS (BASE) 15 GM PHARMACY BULK PACKAGE  INSTITUTO BIOCHIMICO ITALIANO, S.P.A.11/27/2006 
2165-353DOXYCYCLINE TABLETS, 50 MG, 75 MG, AND 100 MG  SANDOZ INC.11/27/2006 
2277-574PACLITAXEL INJECTION USP, 6 MG/ML; 5 ML, 16.7 ML, AND 50 ML VIALS  DABUR ONCOLOGY PLC11/27/2006 
2365-141CEFAZOLIN FOR INJECTION USP, (PHARMACY BULK PACKAGE) 100 G AND 300 G  SAMSON MEDICAL TECHNOLOGIES, L.L.C.11/29/2006 
2477-289CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE) AND 40 MG (BASE)  INTERPHARM INC.11/30/2006 
2577-536MOEXIPRIL HYDROCHLORIDE TABLETS, 7.5 MG AND 15 MG  PADDOCK LABORATORIES, INC.11/30/2006