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U.S. Department of Health and Human Services

Drugs

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Approvals - April 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-770 TERBUTALINE SULFATE INJECTION, USP 1 MG/ML   BEDFORD LABORATORIES 4/23/2004 
2 76-192 RIBAVIRIN CAPSULES 200 MG   SANDOZ, INC. 4/6/2004 
3 76-203 RIBAVIRIN CAPSULES 200 MG   THREE RIVERS PHARMACEUTICALS, LLC 4/6/2004 
4 75-953 TERCONAZOLE VAGINAL CREAM 0.8%   TARO PHARMACEUTICALS U.S.A., INC. 4/6/2004 
5 76-576 SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG, 120 MG, AND 160 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 4/8/2004 
6 76-541 MIRTAZAPINE TABLETS 7.5 MG, 15 MG, 30 MG, AND 45 MG   CARACO PHARMACEUTICAL LABORATORIES, LTD. 4/22/2004 
7 76-815 DIAZEPAM INJECTION, USP 5 MG/ML PACKAGED IN 5 MG/1 ML AND 10 MG/2 ML SINGLE-DOSE VIALS & 50 MG/ML MULTIPLE-DOSE VIALS   PARENTA PHARMACEUTICALS, INC. 4/15/2004 
8 76-483 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG   EON LABS, INC. 4/23/2004 
9 40-539 THEOPHYLLINE EXTENDED-RELEASE TABLETS 600 MG   ABLE LABORATORIES, INC. 4/27/2004 
10 40-543 THEOPHYLLINE EXTENDED-RELEASE TABLETS 400 MG   ABLE LABORATORIES, INC. 4/27/2004 
11 40-517 METHADONE HYDROCHLORIDE TABLETS, USP 5 MG AND 10 MG   MALLINCKRODT INC. 4/27/2004 
12 76-294 KETOCONAZOLE CREAM 2%   ALTANA INC. 4/28/2004 
13 76-661 FLUDARABINE PHOSPHATE INJECTION 25 MG/ML; PACKAGED IN 50 MG/2 ML SINGLE-DOSE VIALS   SICOR PHARMACEUTICALS, INC. 4/28/2004 
14 76-017 GABAPENTIN TABLETS 100 MG, 300 MG, AND 400 MG   IVAX PHARMACEUTICALS, INC. 4/28/2004 
15 76-198 NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.4 MG/0.035 MG; 21-DAY CYCLE (BALZIVA-21 TABLETS)   BARR LABORATORIES, INC. 4/22/2004 
16 76-238 NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.4 MG/0.035 MG; 28-DAY CYCLE (BALZIVA-28 TABLETS)   BARR LABORATORIES, INC. 4/22/2004 
17 76-571 CLADRIBINE INJECTION 1 MG/ML; PACKAGED IN 10 ML SINGLE-DOSE VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 4/22/2004 
18 76-580 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG   RANBAXY LABORATORIES LIMITED 4/23/2004 
19 76-550 PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG   PLIVA, INC. 4/23/2004 
20 76-482 METOLAZONE TABLETS, USP 10 MG   ROXANE LABORATORIES, INC. 4/29/2004 
21 40-546 THEOPHYLLINE EXTENDED-RELEASE TABLETS 450 MG   ABLE LABORATORIES, INC. 4/30/2004 
22 40-548 THEOPHYLLINE EXTENDED-RELEASE TABLETS 300 MG   ABLE LABORATORIES, INC. 4/30/2004 

 

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