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U.S. Department of Health and Human Services

Drugs

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Approvals - April 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-770TERBUTALINE SULFATE INJECTION, USP 1 MG/ML  BEDFORD LABORATORIES4/23/2004 
276-192RIBAVIRIN CAPSULES 200 MG  SANDOZ, INC.4/6/2004 
376-203RIBAVIRIN CAPSULES 200 MG  THREE RIVERS PHARMACEUTICALS, LLC4/6/2004 
475-953TERCONAZOLE VAGINAL CREAM 0.8%  TARO PHARMACEUTICALS U.S.A., INC.4/6/2004 
576-576SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG, 120 MG, AND 160 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.4/8/2004 
676-541MIRTAZAPINE TABLETS 7.5 MG, 15 MG, 30 MG, AND 45 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.4/22/2004 
776-815DIAZEPAM 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 
876-483FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  EON LABS, INC.4/23/2004 
940-539THEOPHYLLINE EXTENDED-RELEASE TABLETS 600 MG  ABLE LABORATORIES, INC.4/27/2004 
1040-543THEOPHYLLINE EXTENDED-RELEASE TABLETS 400 MG  ABLE LABORATORIES, INC.4/27/2004 
1140-517METHADONE HYDROCHLORIDE TABLETS, USP 5 MG AND 10 MG  MALLINCKRODT INC.4/27/2004 
1276-294KETOCONAZOLE CREAM 2%  ALTANA INC.4/28/2004 
1376-661FLUDARABINE PHOSPHATE INJECTION 25 MG/ML; PACKAGED IN 50 MG/2 ML SINGLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.4/28/2004 
1476-017GABAPENTIN TABLETS 100 MG, 300 MG, AND 400 MG  IVAX PHARMACEUTICALS, INC.4/28/2004 
1576-198NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.4 MG/0.035 MG; 21-DAY CYCLE (BALZIVA-21 TABLETS)  BARR LABORATORIES, INC.4/22/2004 
1676-238NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.4 MG/0.035 MG; 28-DAY CYCLE (BALZIVA-28 TABLETS)  BARR LABORATORIES, INC.4/22/2004 
1776-571CLADRIBINE INJECTION 1 MG/ML; PACKAGED IN 10 ML SINGLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.4/22/2004 
1876-580FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  RANBAXY LABORATORIES LIMITED4/23/2004 
1976-550PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG  PLIVA, INC.4/23/2004 
2076-482METOLAZONE TABLETS, USP 10 MG  ROXANE LABORATORIES, INC.4/29/2004 
2140-546THEOPHYLLINE EXTENDED-RELEASE TABLETS 450 MG  ABLE LABORATORIES, INC.4/30/2004 
2240-548THEOPHYLLINE EXTENDED-RELEASE TABLETS 300 MG  ABLE LABORATORIES, INC.4/30/2004