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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-230CEFTRIAXONE FOR INJECTION USP, 250 MG/VIAL, 500 MG/VIAL, 1 G/VIAL, AND 2 G/VIAL  ORCHID HEALTHCARE8/2/2005 
265-231CEFTRIAXONE FOR INJECTION USP, 1 G/VIAL AND 2 G/VIAL  ORCHID HEALTHCARE8/2/2005 
365-232CEFTRIAXONE FOR INJECTION USP, 10 G/VIAL PHARMACY BULK PACKAGE  ORCHID HEALTHCARE8/2/2005 
476-654HYDROCORTISONE BUTYRATE CREAM USP, 0.1%  TARO PHARMACEUTICAL INDUSTRIES LTD.8/3/2005 
577-171CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 0.125 MG, 0.25 MG, 0.5 MG, 1 MG, AND 2 MG  KALI LABORATORIES, INC.8/3/2005 
676-868LOXAPINE CAPSULES USP, 5 MG (BASE), 10 MG (BASE), 25 MG (BASE), AND 50 MG (BASE)  AMIDE PHARMACEUTICAL, INC.8/4/2005 
777-227HALOBETASOL PROPRIONATE CREAM, 0.05%  TARO PHARMACEUTICALS USA, INC.8/4/2005 
876-977CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05%  QLT USA, INC.8/5/2005 
977-092CICLOPIROX TOPICAL SUSPENSION USP (LOTION), 0.77%  TARO PHARMACEUTICALS USA, INC.8/10/2005 
1077-194CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 0.125 MG, 0.25 MG, 0.5 MG, 1 MG, AND 2 MG  BARR LABORATORIES, INC.8/10/2005 
1140-632METHOTREXATE FOR INJECTION USP (PRESERVATIVE-FREE), 1 GRAM/VIAL  BEDFORD LABORATORIES8/12/2005 
1265-242CLINDAMYCIN HYDROCHLORIDE CAPSULES USP, 75 MG (BASE) AND 150 MG (BASE)  LANNETT HOLDINGS, INC.8/12/2005 
1365-243CLINDAMYCIN HYDROCHLORIDE CAPSULES USP, 300 MG (BASE)  LANNETT HOLDINGS, INC.8/12/2005 
1465-244CEFAZOLIN FOR INJECTION USP, 1 G/VIAL  ORCHID HEALTHCARE8/12/2005 
1565-247CEFAZOLIN FOR INJECTION, 10 GRAM/VIAL (PHARMACY BULK PACKAGE)  ORCHID HEALTHCARE8/12/2005 
1676-618PAROXETINE TABLETS USP, 10 MG , 20 MG , 30 MG, AND 40 MG  TEVA PHARMACEUTICALS USA8/15/2005 
1777-144FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, 10 MG/12.5 MG AND 20 MG/12.5 MG  WATSON LABORATORIES, INC.8/16/2005 
1865-234CEPHALEXIN FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML  LUPIN LIMITED8/17/2005 
1976-923LIOTHYRONINE SODIUM INJECTION, 10 MCG(BASE)/ML; 1 ML VIALS  PHARMAFORCE, INC.8/17/2005 
2077-040CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  SANDOZ INC.8/17/2005 
2140-610PHENYTOIN ORAL SUSPENSION USP, 125 MG/5 ML  VISTAPHARM, INC.8/18/2005 
2265-189AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 250 MG/125 MG (BASE)  SANDOZ INC.8/23/2005 
2365-224CEFTRIAXONE INJECTION USP, 1 GRAM/50 ML AND 2 GRAMS/50 ML, PACKAGED IN GALAXY SINGLE-DOSE PLASTIC CONTAINERS  BAXTER HEALTHCARE CORPORATION8/23/2005 
2476-736FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE), 2 MG/ML; 100 ML VIALS  HIKMA FARMACEUTICA (PORTUGAL), LDA8/23/2005 
2540-570PREDNISOLONE SYRUP USP, 5 MG/5 ML  APOTEX INC.8/25/2005 
2640-571PREDNISOLONE SYRUP USP, 15 MG/5 ML  APOTEX INC.8/25/2005 
2765-136CLARITHROMYCIN TABLETS USP, 500 MG  SANDOZ INC.8/25/2005 
2865-250CLARITHROMYCIN EXTENDED-RELEASE TABLETS, 500 MG  SANDOZ INC.8/25/2005 
2977-203CHOLESTYRAMINE FOR ORAL SUSPENSION USP, (LIGHT) 4 GRAMS OF RESIN/SCOOPFUL OR PACKET  PAR PHARMACEUTICAL, INC.8/26/2005 
3077-204CHOLESTYRAMINE FOR ORAL SUSPENSION USP, 4 G RESIN/ 9 G SCOOPFUL OR PACKET  PAR PHARMACEUTICAL, INC.8/26/2005 
3177-068BACLOFEN TABLETS USP, 20 MG  VINTAGE PHARMACEUTICALS, LLC8/30/2005 
3277-156BACLOFEN TABLETS USP, 10 MG  VINTAGE PHARMACEUTICALS, LLC8/30/2005 
3376-191FEXOFENADINE HYDROCHLORIDE TABLETS, 30 MG, 60 MG, AND 180 MG  BARR LABORATORIES, INC.8/31/2005 
3476-689MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, 15 MG, 30 MG, AND 45 MG  AMIDE PHARMACEUTICAL, INC.8/31/2005