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U.S. Department of Health and Human Services

Drugs

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Approvals March 2001

 ANDA NumberDrug NameApplicantApproval Date
175-689HALOPERIDOL INJECTION USP, 5 MG (BASE)/ML 5 MG (BASE)/MLAMERICAN PHARMACEUTICAL PARTNERS, INC.3/9/01
275-751DESONIDE OINTMENT 0.05%ALTANA, INC.3/12/01
375-898FLUVOXAMINE MALEATE TABLETS 25 MG 50 MG 100 MGZENITH GOLDLINE PHARMACEUTICALS, INC.3/12/01
440-388HYDRALAZINE HYDROCHLORIDE INJECTION, USP 20 MG/MLAMERICAN PHARMACEUTICAL PARTNERS INC.3/13/01
565-028RIFAMPIN CAPSULES, USP 150 MG 300 MGAPPLIED ANALYTICAL INDUSTRIES, INC.3/14/01
640-385METHOTREXATE TABLETS, USP 5 MG 7.5 MG 10 MG 15 MGBARR LABORATORIES, INC.3/21/01
775-178ENALAPRIL MALEATE TABLETS, USP 2.5 MG 5 MG 10 MG 20 MGTORPHARM3/23/01
875-618BUTALBITAL, ACETAMINOPHEN & CAFFEINE WITH CODEINE PHOS. CAPS 50 MG/325 MG/40 MG/30 MGWEST-WARD PHARMACEUTICAL CORP.3/23/01
940-411METHIMAZOLE TABLETS, USP 5 MG 10 MGEON LABS MANUFACTURING, INC.3/27/01
1075-297PACLITAXEL INJECTION 6 MG/ML (30 MG/5 ML) (100 MG/16.7 ML) AND 150 MG/25 ML)ZENITH GOLDLINE PHARMACEUTICALS, INC.3/27/01
1174-253BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG 10 MGDANBURY PHARMACAL, INC.3/28/01
1275-272BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MGMYLAN PHARMACEUTICALS, INC.3/28/01
1375-441IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02%NOVEX PHARMA3/28/01
1475-467BUSPIRONE HYDROCHLORIDE TABLETS, USP 7.5 MGPAR PHARMACEUTICAL, INC.3/28/01
1575-627ACYCLOVIR INJECTION 50 MG/ML; (500 MG/10 ML) AND (1 G/20 ML).GENSIA SICOR PHARMACEUTICALS, INC.3/28/01
1640-404METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP 5 MG 10 MG 20 MGABLE LABORATORIES, INC.3/29/01
1775-567LEVOCARNITINE INJECTION, USP 200 MG/ML; (500 MG/2.5 ML), AND (1 G/5 ML) VIALSBEDFORD LABORATORIES3/29/01
1875-881LEVOCARNITINE INJECTION, USP 200 MG/ML (500 MG/2.5 ML) (1 G/5 ML) (2.5 G/12.5 ML) VIALSGENSIA SICOR PHARMACEUTICALS, INC.3/29/01
1975-424AMIODARONE HYDROCHLORIDE TABLETS 200 MGTARO PHARMACEUTICAL INDUSTRIES, LTD.3/30/01
2075-726PEMOLINE TABLETS 18.75 MG 37.5 MG 75 MGMALLINCKRODT, INC.3/30/01