Drug Information |
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 |
FDA/Center for Drug Evaluation and Research
Last Updated: November 6, 2002
Originator: OTCOM/DLIS
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