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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2001

 ANDA NumberDrug NameApplicantApproval Date
140-374TRIAMCINOLONE ACETONIDE OINTMENT, USP 0.025%THAMES PHARMACAL CO., INC.6/5/01
240-386TRIAMCINOLONE ACETONIDE OINTMENT, USP 0.5%THAMES PHARMACAL CO., INC.6/5/01
375-502CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05% (BASE)ALTANA INC.6/5/01
475-750DOXAZOSIN MESYLATE TABLETS 1 MG (BASE), 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE)SIDMAK LABORATORIES, INC.6/8/01
575-598MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5%L. PERRIGO COMPANY6/13/01
675-795GLIPIZIDE TABLETS, USP 5 MG AND 10 MGTORPHARM6/13/01
775-300LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGGENEVA PHARMACEUTICALS, INC.6/15/01
875-451LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGMYLAN PHARMACEUTICALS, INC.6/15/01
975-551LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGTEVA PHARMACEUTICALS USA6/15/01
1075-636LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGEON LABS MANUFACTURING, INC.6/15/01
1175-812DACARBAZINE FOR INJECTION, USP 200 MG/VIALBEDFORD LABORATORIES6/15/01
1275-935LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGGENPHARM INC.6/15/01
1375-858HALOPERIDOL INJECTION, USP 5 MG/MLBEDFORD LABORATORIES6/18/01
1440-421CARISOPRODOL TABLETS, USP 350 MGABLE LABORATORIES, INC.6/21/01
1575-861LEVOCARNITINE INJECTION, USP 200 MG/ML (500 MG/2.5 ML & 1G/5 ML SINGLE-DOSE VIALS).LUITPOLD PHARMACEUTICALS, INC.6/22/01
1675-644BISOPROLOL FUMARATE TABLETS 5 MG, AND 10 MGCOPLEY PHARMACEUTICAL, INC.6/26/01
1775-664ALBUTEROL SULFATE INHALATION SOLUTION 0.5% (BASE), PACKAGED IN 2.5 MG/0.5 ML UNIT-OF-USE VIALSNEPHRON PHARMACEUTICALS CORPORATION6/26/01
1875-877TERBUTALINE SULFATE TABLETS, USP 2.5 MG, AND 5 MGIMPAX LABORATORIES, INC.6/26/01
1940-418HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG AND 500 MG, RESPECTIVELY, PER 15 ML.MALLINCKRODT, INC.6/27/01
2076-008BUSPIRONE HYDROCHLORIDE TABLETS, USP 30 MGMYLAN TECHNOLOGIES, INC.6/28/01
2165-027CLINDAMYCIN IN 5% DEXTROSE INJECTION 300 MG/50 ML (6 MG/ML), 600 MG/50 ML (12 MG/ML), AND 900 MG/50 ML (18 MG/ML)ABBOTT LABORATORIES6/29/01
2275-631KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML (1 ML SINGLE-DOSE VIAL); AND 30 MG/ML (1 ML & 2 ML SINGLE-DOSE VIALS)APOTEX CORP.6/29/01