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U.S. Department of Health and Human Services

Drugs

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Approvals January 2001

 ANDA NUMBERDRUG NAMEAPPLICANTAPPROVAL DATE
165-057CEFACLOR EXTENDED-RELEASE TABLETS USP, 500 MGZENITH GOLDLINE PHARMACEUTICALS, INC.1/5/01
275-887FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, 100 MGINVAMED INC.1/5/01
375-353DOXAZOSIN MESYLATE TABLETS, 1 MG (BASE), 2 MG (BASE), 4 MG (BASE), 8 MG (BASE)TEVA PHARMACEUTICALS USA1/12/01
475-899FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, 100 MGSYNTHON PHARMACEUTICALS LTD.1/17/01
575-507IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%WARRICK PHARMACEUTICALS1/19/01
675-686BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 MG/6.25 MG, 5 MG/6.25 MG, 10 MG/6.25 MGTEVA PHARMACEUTICALS USA1/19/01
775-657ENALAPRIL MALEATE TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MGTARO PHARMACEUTICAL INDUSTRIES, LTD.1/23/01
875-389AMIODARONE HYDROCHLORIDE TABLETS, 200 MGBARR LABORATORIES, INC.1/25/01
975-897FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, 100 MGBARR LABORATORIES, INC.1/25/01
1075-051METOCLOPRAMIDE ORAL SOLUTION USP, 5 MG/5 MLUDL LABORATORIES, INC.1/26/01
1175-615CROMOLYN SODIUM OPHTHALMIC SOLUTION USP, 4%NOVEX PHARMA1/26/01
1275-693IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% ,ASLUNG PHARMACEUTICAL, L.P.1/26/01
1375-614TERAZOSIN HYDROCHLORIDE CAPSULES, 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), 10 MG (BASE)ZENITH GOLDLINE PHARMACEUTICALS, INC.1/30/01
1475-656MORPHINE SULFATE EXTENDED-RELEASE TABLETS, 100 MGWATSON LABORATORIES, INC.1/30/01
1540-338LEUCOVORIN CALCIUM INJECTION USP, 50 MG (BASE)/VIAL (PRESERVATIVE-FREE)LUITPOLD PHARMACEUTICALS, INC.1/31/01
1640-342PHENYTOIN ORAL SUSPENSION USP, 100 MG/5 MLUDL LABORATORIES, INC.1/31/01
1740-361DEXTROAMPHETAMINE SULFATE TABLETS USP, 5 MG, 10 MGBARR LABORATORIES, INC.1/31/01
1875-845OXAPROZIN TABLETS, 600 MGEON LABS MANUFACTURING, INC.1/31/01
1975-855OXAPROZIN TABLETS, 600 MGDR. REDDY'S LABORATORIES LIMITED1/31/01