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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2002

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
175-183PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 MLHI-TECH PHARMACAL CO., INC.10/17/02
275-268OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MGGENPHARM INC.10/18/02
375-791OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MGEON LABS, INC.10/24/02
476-302NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MGEON LABS, INC.10/28/02
576-073NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150 MG, 200 MG, AND 250 MGWATSON LABORATORIES, INC.10/29/02
676-129NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150 MG, 200 MG, AND 250 MGMYLAN PHARMACEUTICALS, INC.10/29/02