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Tentative Approvals - October 2002

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 75-183 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML HI-TECH PHARMACAL CO., INC. 10/17/02
2 75-268 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MG GENPHARM INC. 10/18/02
3 75-791 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG EON LABS, INC. 10/24/02
4 76-302 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG EON LABS, INC. 10/28/02
5 76-073 NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150 MG, 200 MG, AND 250 MG WATSON LABORATORIES, INC. 10/29/02
6 76-129 NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150 MG, 200 MG, AND 250 MG MYLAN PHARMACEUTICALS, INC. 10/29/02

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FDA/Center for Drug Evaluation and Research
Last Updated: November 6, 2002
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