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U.S. Department of Health and Human Services

Drugs

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Approvals March 2001

  ANDA Number Drug Name Applicant Approval Date
1 75-689 HALOPERIDOL INJECTION USP, 5 MG (BASE)/ML 5 MG (BASE)/ML AMERICAN PHARMACEUTICAL PARTNERS, INC. 3/9/01
2 75-751 DESONIDE OINTMENT 0.05% ALTANA, INC. 3/12/01
3 75-898 FLUVOXAMINE MALEATE TABLETS 25 MG 50 MG 100 MG ZENITH GOLDLINE PHARMACEUTICALS, INC. 3/12/01
4 40-388 HYDRALAZINE HYDROCHLORIDE INJECTION, USP 20 MG/ML AMERICAN PHARMACEUTICAL PARTNERS INC. 3/13/01
5 65-028 RIFAMPIN CAPSULES, USP 150 MG 300 MG APPLIED ANALYTICAL INDUSTRIES, INC. 3/14/01
6 40-385 METHOTREXATE TABLETS, USP 5 MG 7.5 MG 10 MG 15 MG BARR LABORATORIES, INC. 3/21/01
7 75-178 ENALAPRIL MALEATE TABLETS, USP 2.5 MG 5 MG 10 MG 20 MG TORPHARM 3/23/01
8 75-618 BUTALBITAL, ACETAMINOPHEN & CAFFEINE WITH CODEINE PHOS. CAPS 50 MG/325 MG/40 MG/30 MG WEST-WARD PHARMACEUTICAL CORP. 3/23/01
9 40-411 METHIMAZOLE TABLETS, USP 5 MG 10 MG EON LABS MANUFACTURING, INC. 3/27/01
10 75-297 PACLITAXEL 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
11 74-253 BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG 10 MG DANBURY PHARMACAL, INC. 3/28/01
12 75-272 BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MG MYLAN PHARMACEUTICALS, INC. 3/28/01
13 75-441 IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% NOVEX PHARMA 3/28/01
14 75-467 BUSPIRONE HYDROCHLORIDE TABLETS, USP 7.5 MG PAR PHARMACEUTICAL, INC. 3/28/01
15 75-627 ACYCLOVIR INJECTION 50 MG/ML; (500 MG/10 ML) AND (1 G/20 ML). GENSIA SICOR PHARMACEUTICALS, INC. 3/28/01
16 40-404 METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP 5 MG 10 MG 20 MG ABLE LABORATORIES, INC. 3/29/01
17 75-567 LEVOCARNITINE INJECTION, USP 200 MG/ML; (500 MG/2.5 ML), AND (1 G/5 ML) VIALS BEDFORD LABORATORIES 3/29/01
18 75-881 LEVOCARNITINE INJECTION, USP 200 MG/ML (500 MG/2.5 ML) (1 G/5 ML) (2.5 G/12.5 ML) VIALS GENSIA SICOR PHARMACEUTICALS, INC. 3/29/01
19 75-424 AMIODARONE HYDROCHLORIDE TABLETS 200 MG TARO PHARMACEUTICAL INDUSTRIES, LTD. 3/30/01
20 75-726 PEMOLINE TABLETS 18.75 MG 37.5 MG 75 MG MALLINCKRODT, INC. 3/30/01
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