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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
 77-361TRIMIPRAMINE MALEATE CAPSULES 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  AMIDE PHARMACEUTICAL, INC.8/2/2006 
276-690VENLAFAXINE HYDROCHLORIDE TABLETS 25 MG (BASE), 37.5 MG (BASE), 50 MG (BASE), 75 MG (BASE), AND 100 MG (BASE)  TEVA PHARMACEUTICALS USA8/3/2006 
377-704FLUNISOLIDE NASAL SOLUTION USP, 0.025% (0.025 MG/SPRAY) METERED NASAL SPRAY  Q-PHARMA LLC8/3/2006 
477-051FENTANYL TRANSDERMAL SYSTEM 25 MCG/HOUR, 50 MCG/HOUR, 75 MCG/HOUR, AND 100 MCG/HOUR  LAVIPHARM LABORATORIES, INC.8/4/2006 
540-615TESTOSTERONE CYPIONATE INJECTION USP, 100 MG/ML AND 200 MG/ML  SANDOZ CANADA, INC.8/10/2006 
665-292CEFOTAXIME FOP INJECTION USP, 10 G (BASE)/VIAL (PHARMACY BULK PACKAGE)  ORCHID HEALTHCARE8/10/2006 
765-293CEFOTAXIME FOR INJECTION USP, 1 G(BASE)/VIAL AND 2 G(BASE)/VIAL PACKAGED IN INFUSION BOTTLES  ORCHID HEALTHCARE8/10/2006 
865-290CEFOTAXIME FOR INJECTION USP, 500 MG (BASE)/VIAL, 1 G (BASE)/VIAL, AND 2 G (BASE)/VIAL  ORCHID HEALTHCARE8/11/2006 
976-465SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  TEVA PHARMACEUTICALS USA8/11/2006 
1077-393STERILE WATER FOR INJECTION USP, PACKAGED IN SINGLE-DOSE PLASTIC AMPULES  TARO PHARMACEUTICALS IRELAND LTD.8/11/2006 
1177-407SODIUM CHLORIDE INJECTION USP, 0.9% PACKAGED IN 5 ML & 10 ML SINGLE-DOSE PLASTIC AMPULES  TARO PHARMACEUTICALS IRELAND LTD.8/11/2006 
1277-628IBUPROFEN AND PSEUROEPHEDRINE HYDROCHLORIDE TABLETS USP, 200 MG/30 MG (OTC)  DR. REDDY'S LABORATORIES LIMITED8/14/2006 
1377-705FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG  GENPHARM INC.8/14/2006 
1477-862BACLOFEN TABLETS USP, 20 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.8/14/2006 
1577-984BACLOFEN TABLETS USP, 10 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.8/14/2006 
1677-813ZONISAMIDE CAPSULES 25 MG, 50 MG, AND 100 MG  BANNER PHARMACAPS, INC.8/16/2006 
1776-626NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.18 MG/0.035 MG, 0.215 MG/0.035 MG, AND 0.25 MG/0.035 MG, RESPECTIVELY; PACKAGED IN A 28-DAY CYCLE REGIMEN  WATSON LABORATORIES, INC.8/17/2006 
1876-627NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.25 MG/0.035 MG, RESPECTIVELY; PACKAGED IN A 28-DAY CYCLE REGIMEN  WATSON LABORATORIES, INC.8/17/2006 
1965-321NYSTATIN TOPICAL POWDER USP, 100,000 UNITS/GRAM  KV PHARMACEUTICAL COMPANY8/18/2006 
2077-662GABAPENTIN TABLETS 600 MG AND 800 MG  GLENMARK PHARMACEUTICALS LIMITED8/18/2006 
2177-787METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG  DR. REDDY'S LABORATORIES LTD.8/23/2006 
2277-242GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  SUN PHARMACEUTICAL INDUSTRIES LTD.8/24/2006 
2377-525GABAPENTIN TABLETS 600 MG AND 800 MG  SUN PHARMACEUTICAL INDUSTRIES LTD.8/24/2006 
2440-729HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/500 MG  INTERPHARM INC.8/25/2006 
2540-736HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/325 MG  INTERPHARM INC.8/25/2006 
2640-746HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 10 MG/325 MG  INTERPHARM INC.8/25/2006 
2740-748HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/500 MG  INTERPHARM INC.8/25/2006 
2840-754HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/650 MG  INTERPHARM INC.8/25/2006 
2940-757HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 10 MG/650 MG  INTERPHARM INC.8/25/2006 
3040-769HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/750 MG  INTERPHARM INC.8/28/2006 
3176-484CIPROFLOXACIN INJECTION USP, 10 MG/ML, PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS  ABRAXIS PHARMACEUTICAL PRODUCTS8/28/2006 
3276-992CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES8/28/2006 
3376-993CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 1200 MG/120 ML SINGLE-USE VIAL; PHARMACY BULK PACKAGE  BEDFORD LABORATORIES8/28/2006 
3477-245CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS  HOSPIRA INC.8/28/2006 
3577-782CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS  SICOR PHARMACEUTICALS, INC.8/28/2006 
3677-812CITALOPRAM HYDROBROMIDE ORAL SOLUTION 10 MG (BASE)/5 ML  AUROBINDO PHARMA LIMITED8/28/2006 
3777-878METOCLOPRAMIDE TABLETS USP, 5 MG AND 10 MG  VINTAGE PHARMACEUTICALS, LLC8/28/2006 
3840-750SPIRONOLACTONE TABLETS USP, 25 MG, 50 MG, AND 100 MG  VINTAGE PHARMACEUTICALS, LLC8/29/2006 
3965-197CEFOTAXIME FOR INJECTION USP, 1 GRAM/VIAL  WOCKHARDT LIMITED8/29/2006 
4076-388LAMOTRIGINE TABLETS 25 MG, 100 MG, 150 MG, AND 200 MG  TEVA PHARMACEUTICALS USA8/30/2006 
4140-653GLYCOPYRROLATE TABLETS 1 MG AND 2 MG  KALI LABORATORIES, INC.8/31/2006 
4277-531FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  COBALT PHARMACEUTICALS, INC.8/31/2006