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U.S. Department of Health and Human Services

Drugs

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Approvals - July 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
177-052CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  MUTUAL PHARMACEUTICAL COMPANY, INC.7/3/2006 
240-616WARFARIN SODIUM TABLETS USP, 1 MG, 2 MG, 2.5 MG, 3 MG, 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG  PLIVA INC.7/5/2006 
365-246AZITHROMYCIN FOR ORAL SUSPENSION USP, 100 MG/5 ML AND 200 MG/5 ML  PLIVA, INC.7/5/2006 
476-232AMIODARONE HYDROCHLORIDE INJECTION, 50 MG/ML; 3 ML AMPULES  AKORN INC.7/5/2006 
576-945FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, 10 MG/12.5 MG AND 20 MG/12.5 MG  TEVA PHARMACEUTICALS USA7/5/2006 
676-877GABAPENTIN TABLETS, 600 MG AND 800 MG  SANDOZ INC.7/6/2006 
765-326CEPHALEXIN FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML  ORCHID HEALTHCARE7/10/2006 
877-820GLIPIZIDE TABLETS USP, 5 MG AND 10 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.7/11/2006 
976-850TERCONAZOLE VAGINAL SUPPOSITORIES, 80 MG  ALTANA INC.7/12/2006 
1077-547METRONIDAZOLE TOPICAL GEL USP, 0.75%  QLT USA, INC.7/13/2006 
1140-622PROMETHAZINE HYDROCHLORIDE TABLETS USP, 12.5 MG, 25 MG, AND 50 MG  VINTAGE PHARMACEUTICALS, LLC7/18/2006 
1277-819METRONIDAZOLE TOPICAL GEL USP, 0.75%  TARO PHARMACEUTICAL INDUSTRIES LTD.7/18/2006 
1377-920MELOXICAM TABLETS, 7.5 MG AND 15 MG  BRECKENRIDGE PHARMACEUTICAL, INC.7/19/2006 
1477-921MELOXICAM TABLETS, 7.5 MG AND 15 MG  ZYDUS PHARMACEUTICALS USA, INC.7/19/2006 
1577-923MELOXICAM TABLETS, 7.5 MG AND 15 MG  MYLAN PHARMACEUTICALS, INC.7/19/2006 
1677-925MELOXICAM TABLETS, 7.5 MG AND 15 MG  ROXANE LABORATORIES, INC.7/19/2006 
1777-929MELOXICAM TABLETS, 7.5 MG AND 15 MG  WATSON LABORATORIES, INC.7/19/2006 
1877-930MELOXICAM TABLETS, 7.5 MG AND 15 MG  COREPHARMA LLC7/19/2006 
1977-932MELOXICAM TABLETS, 7.5 MG AND 15 MG  GLENMARK PHARMACEUTICALS LTD.7/19/2006 
2077-933MELOXICAM TABLETS, 7.5 MG AND 15 MG  PAR PHARMACEUTICAL7/19/2006 
2177-935MELOXICAM TABLETS, 7.5 MG AND 15 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.7/19/2006 
2277-936MELOXICAM TABLETS, 7.5 MG AND 15 MG  TEVA PHARMACEUTICALS, USA7/19/2006 
2377-937MELOXICAM TABLETS, 7.5 MG AND 15 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.7/19/2006 
2477-938MELOXICAM TABLETS, 7.5 MG AND 15 MG  ACTAVIS TOTOWA LLC7/19/2006 
2577-944MELOXICAM TABLETS, 7.5 MG AND 15 MG  LUPIN LIMITED7/19/2006 
2677-882MELOXICAM TABLETS, 7.5 MG AND 15 MG  APOTEX INC.7/20/2006 
2777-934MELOXICAM TABLETS, 7.5 MG AND 15 MG  GENPHARM INC.7/20/2006 
2865-240AMPICILLIN AND SULBACTAM FOR INJECTION USP, 10 G(BASE) AND 5 G(BASE), RESPECTIVELY, (PHARMACY BULK PACKAGE)  SANDOZ INC.7/25/2006 
2965-241AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1.5 G AND 3 MG; PACKAGED IN VIALS  SANDOZ INC.7/25/2006 
3065-310AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1.5 G AND 3 G; PACKAGED IN ADD-VANTAGE VIALS  SANDOZ INC.7/25/2006 
3165-320ERYTHROMYCIN PLEDGETS USP, 2%  ALTANA INC.7/25/2006 
3277-931MELOXICAM TABLETS, 7.5 MG AND 15 MG  DR. REDDY'S LABORATORIES LIMITED7/25/2006 
3376-756METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG  SYNOVICS LABORATORIES, INC.7/26/2006 
3476-914TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, 37.5 MG/325 MG  BARR LABORATORIES, INC.7/26/2006 
3540-667PRIMIDONE TABLETS USP, 50 MG AND 250 MG  WEST-WARD PHARMACEUTICAL CORP.7/27/2006 
3677-836GEMFIBROZIL TABLETS USP, 600 MG  INVAGEN PHARMACEUTICALS, INC.7/27/2006 
3777-895URSODIOL CAPSULES USP, 300 MG  COREPHARMA LLC7/27/2006 
3865-220NEOMYCIN SULFATE TABLETS USP, 500 MG [350 MG (BASE)]  X-GEN PHARMACEUTICALS, INC.7/28/2006 
3976-436FINASTERIDE TABLETS USP, 1 MG  DR. REDDY'S LABORATORIES LIMITED7/28/2006 
4077-853METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG  AMNEAL PHARMACEUTICALS LLC7/28/2006 
4140-712PROMETHAZINE HYDROCHLORIDE TABLETS USP, 25 MG  KVK-TECH, INC.7/31/2006 
4240-713PROMETHAZINE HYDROCHLORIDE TABLETS USP, 50 MG  KVK-TECH, INC.7/31/2006 
4376-969METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS, USP 25 MG  SANDOZ INC.7/31/2006 
4477-725ALPRAZOLAM EXTENDED-RELEASE TABLETS 0.5 MG, 1 MG, 2 MG, AND 3 MG  BARR LABORATORIES, INC.7/31/2006