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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 65-230 CEFTRIAXONE FOR INJECTION USP, 250 MG/VIAL, 500 MG/VIAL, 1 G/VIAL, AND 2 G/VIAL   ORCHID HEALTHCARE 8/2/2005 
2 65-231 CEFTRIAXONE FOR INJECTION USP, 1 G/VIAL AND 2 G/VIAL   ORCHID HEALTHCARE 8/2/2005 
3 65-232 CEFTRIAXONE FOR INJECTION USP, 10 G/VIAL PHARMACY BULK PACKAGE   ORCHID HEALTHCARE 8/2/2005 
4 76-654 HYDROCORTISONE BUTYRATE CREAM USP, 0.1%   TARO PHARMACEUTICAL INDUSTRIES LTD. 8/3/2005 
5 77-171 CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 0.125 MG, 0.25 MG, 0.5 MG, 1 MG, AND 2 MG   KALI LABORATORIES, INC. 8/3/2005 
6 76-868 LOXAPINE CAPSULES USP, 5 MG (BASE), 10 MG (BASE), 25 MG (BASE), AND 50 MG (BASE)   AMIDE PHARMACEUTICAL, INC. 8/4/2005 
7 77-227 HALOBETASOL PROPRIONATE CREAM, 0.05%   TARO PHARMACEUTICALS USA, INC. 8/4/2005 
8 76-977 CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05%   QLT USA, INC. 8/5/2005 
9 77-092 CICLOPIROX TOPICAL SUSPENSION USP (LOTION), 0.77%   TARO PHARMACEUTICALS USA, INC. 8/10/2005 
10 77-194 CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 0.125 MG, 0.25 MG, 0.5 MG, 1 MG, AND 2 MG   BARR LABORATORIES, INC. 8/10/2005 
11 40-632 METHOTREXATE FOR INJECTION USP (PRESERVATIVE-FREE), 1 GRAM/VIAL   BEDFORD LABORATORIES 8/12/2005 
12 65-242 CLINDAMYCIN HYDROCHLORIDE CAPSULES USP, 75 MG (BASE) AND 150 MG (BASE)   LANNETT HOLDINGS, INC. 8/12/2005 
13 65-243 CLINDAMYCIN HYDROCHLORIDE CAPSULES USP, 300 MG (BASE)   LANNETT HOLDINGS, INC. 8/12/2005 
14 65-244 CEFAZOLIN FOR INJECTION USP, 1 G/VIAL   ORCHID HEALTHCARE 8/12/2005 
15 65-247 CEFAZOLIN FOR INJECTION, 10 GRAM/VIAL (PHARMACY BULK PACKAGE)   ORCHID HEALTHCARE 8/12/2005 
16 76-618 PAROXETINE TABLETS USP, 10 MG , 20 MG , 30 MG, AND 40 MG   TEVA PHARMACEUTICALS USA 8/15/2005 
17 77-144 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, 10 MG/12.5 MG AND 20 MG/12.5 MG   WATSON LABORATORIES, INC. 8/16/2005 
18 65-234 CEPHALEXIN FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML   LUPIN LIMITED 8/17/2005 
19 76-923 LIOTHYRONINE SODIUM INJECTION, 10 MCG(BASE)/ML; 1 ML VIALS   PHARMAFORCE, INC. 8/17/2005 
20 77-040 CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   SANDOZ INC. 8/17/2005 
21 40-610 PHENYTOIN ORAL SUSPENSION USP, 125 MG/5 ML   VISTAPHARM, INC. 8/18/2005 
22 65-189 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 250 MG/125 MG (BASE)   SANDOZ INC. 8/23/2005 
23 65-224 CEFTRIAXONE INJECTION USP, 1 GRAM/50 ML AND 2 GRAMS/50 ML, PACKAGED IN GALAXY SINGLE-DOSE PLASTIC CONTAINERS   BAXTER HEALTHCARE CORPORATION 8/23/2005 
24 76-736 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE), 2 MG/ML; 100 ML VIALS   HIKMA FARMACEUTICA (PORTUGAL), LDA 8/23/2005 
25 40-570 PREDNISOLONE SYRUP USP, 5 MG/5 ML   APOTEX INC. 8/25/2005 
26 40-571 PREDNISOLONE SYRUP USP, 15 MG/5 ML   APOTEX INC. 8/25/2005 
27 65-136 CLARITHROMYCIN TABLETS USP, 500 MG   SANDOZ INC. 8/25/2005 
28 65-250 CLARITHROMYCIN EXTENDED-RELEASE TABLETS, 500 MG   SANDOZ INC. 8/25/2005 
29 77-203 CHOLESTYRAMINE FOR ORAL SUSPENSION USP, (LIGHT) 4 GRAMS OF RESIN/SCOOPFUL OR PACKET   PAR PHARMACEUTICAL, INC. 8/26/2005 
30 77-204 CHOLESTYRAMINE FOR ORAL SUSPENSION USP, 4 G RESIN/ 9 G SCOOPFUL OR PACKET   PAR PHARMACEUTICAL, INC. 8/26/2005 
31 77-068 BACLOFEN TABLETS USP, 20 MG   VINTAGE PHARMACEUTICALS, LLC 8/30/2005 
32 77-156 BACLOFEN TABLETS USP, 10 MG   VINTAGE PHARMACEUTICALS, LLC 8/30/2005 
33 76-191 FEXOFENADINE HYDROCHLORIDE TABLETS, 30 MG, 60 MG, AND 180 MG   BARR LABORATORIES, INC. 8/31/2005 
34 76-689 MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, 15 MG, 30 MG, AND 45 MG   AMIDE PHARMACEUTICAL, INC. 8/31/2005 
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