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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 76-093 OFLOXACIN TABLETS 200 MG 300 MG 400 MG PAR PHARMACEUTICAL, INC 12/5/01
2 75-752 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG ZENITH GOLDLINE PHARMACEUTICALS, INC. 12/19/01
3 75-999 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG 40 MG LEK PHARMACEUTICAL AND CHEMICAL CO. d.d. 12/19/01
4 76-134 LORATADINE TABLETS 10 MG RANBAXY LABORATORIES LIMITED 12/20/01
5 76-058 MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML RANBAXY LABORATORIES, LTD. 12/21/01
6 76-136 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG TEVA PHARMACEUTICALS USA 12/26/01
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