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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2001

  ANDA NUMBER DRUG NAME APPLICANT TENTATIVE APPROVAL DATE
1 75-790 LORATADINE TABLETS 10 MG MYLAN PHARMACEUTICALS, INC. 1/12/01
2 75-684 FAMOTIDINE INJECTION 10 MG/ ML (PHARMACY BULK PACKAGE) BEDFORD LABORATORIES 1/24/01
3 75-825 FAMOTIDINE INJECTION (PRESERVATIVE FREE) 10 MG/ML (PHARMACY BULK PACKAGE) BEN VENUE LABORATORIES, INC. 1/25/01
4 75-505 LORATADINE SYRUP 10 MG/10 ML TEVA PHARMACEUTICALS USA 1/29/01
5 75-783 LISINOPRIL TABLETS USP, 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, 40 MG TEVA PHARMACEUTICALS USA 1/30/01
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