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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
176-093OFLOXACIN TABLETS 200 MG 300 MG 400 MGPAR PHARMACEUTICAL, INC12/5/01
275-752LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGZENITH GOLDLINE PHARMACEUTICALS, INC.12/19/01
375-999LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG 40 MGLEK PHARMACEUTICAL AND CHEMICAL CO. d.d.12/19/01
476-134LORATADINE TABLETS 10 MGRANBAXY LABORATORIES LIMITED12/20/01
576-058MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/MLRANBAXY LABORATORIES, LTD.12/21/01
676-136CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MGTEVA PHARMACEUTICALS USA12/26/01