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Drug Information

Approvals January 2001

  ANDA NUMBER DRUG NAME APPLICANT APPROVAL DATE
1 65-057 CEFACLOR EXTENDED-RELEASE TABLETS USP, 500 MG ZENITH GOLDLINE PHARMACEUTICALS, INC. 1/5/01
2 75-887 FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, 100 MG INVAMED INC. 1/5/01
3 75-353 DOXAZOSIN MESYLATE TABLETS, 1 MG (BASE), 2 MG (BASE), 4 MG (BASE), 8 MG (BASE) TEVA PHARMACEUTICALS USA 1/12/01
4 75-899 FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, 100 MG SYNTHON PHARMACEUTICALS LTD. 1/17/01
5 75-507 IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% WARRICK PHARMACEUTICALS 1/19/01
6 75-686 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 MG/6.25 MG, 5 MG/6.25 MG, 10 MG/6.25 MG TEVA PHARMACEUTICALS USA 1/19/01
7 75-657 ENALAPRIL MALEATE TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG TARO PHARMACEUTICAL INDUSTRIES, LTD. 1/23/01
8 75-389 AMIODARONE HYDROCHLORIDE TABLETS, 200 MG BARR LABORATORIES, INC. 1/25/01
9 75-897 FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, 100 MG BARR LABORATORIES, INC. 1/25/01
10 75-051 METOCLOPRAMIDE ORAL SOLUTION USP, 5 MG/5 ML UDL LABORATORIES, INC. 1/26/01
11 75-615 CROMOLYN SODIUM OPHTHALMIC SOLUTION USP, 4% NOVEX PHARMA 1/26/01
12 75-693 IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% , ASLUNG PHARMACEUTICAL, L.P. 1/26/01
13 75-614 TERAZOSIN HYDROCHLORIDE CAPSULES, 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), 10 MG (BASE) ZENITH GOLDLINE PHARMACEUTICALS, INC. 1/30/01
14 75-656 MORPHINE SULFATE EXTENDED-RELEASE TABLETS, 100 MG WATSON LABORATORIES, INC. 1/30/01
15 40-338 LEUCOVORIN CALCIUM INJECTION USP, 50 MG (BASE)/VIAL (PRESERVATIVE-FREE) LUITPOLD PHARMACEUTICALS, INC. 1/31/01
16 40-342 PHENYTOIN ORAL SUSPENSION USP, 100 MG/5 ML UDL LABORATORIES, INC. 1/31/01
17 40-361 DEXTROAMPHETAMINE SULFATE TABLETS USP, 5 MG, 10 MG BARR LABORATORIES, INC. 1/31/01
18 75-845 OXAPROZIN TABLETS, 600 MG EON LABS MANUFACTURING, INC. 1/31/01
19 75-855 OXAPROZIN TABLETS, 600 MG DR. REDDY'S LABORATORIES LIMITED 1/31/01

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FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OGC
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