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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2001

 ANDA NUMBERDRUG NAMEAPPLICANTTENTATIVE APPROVAL DATE
175-790LORATADINE TABLETS 10 MGMYLAN PHARMACEUTICALS, INC.1/12/01
275-684FAMOTIDINE INJECTION 10 MG/ ML (PHARMACY BULK PACKAGE)BEDFORD LABORATORIES1/24/01
375-825FAMOTIDINE INJECTION (PRESERVATIVE FREE) 10 MG/ML (PHARMACY BULK PACKAGE)BEN VENUE LABORATORIES, INC.1/25/01
475-505LORATADINE SYRUP 10 MG/10 MLTEVA PHARMACEUTICALS USA1/29/01
575-783LISINOPRIL TABLETS USP, 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, 40 MGTEVA PHARMACEUTICALS USA1/30/01