Tentative Approvals - 2002
| |
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
75-753 |
FENOFIBRATE CAPSULES (MICRONIZED) 67 MG |
NOVOPHARM LIMITED |
4/9/02 |
| 2 |
76-108 |
AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML |
FAULDING PHARMACEUTICAL CO. |
4/12/02 |
| 3 |
76-172 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG |
ANDRX PHARMACEUTICALS, INC. |
4/18/02 |
| 4 |
76-184 |
ALENDRONATE SODIUM TABLETS 35 MG AND 70 MG |
BARR LABORATORIES, INC. |
4/23/02 |
| 5 |
76-062 |
ZOLPIDEM TARTRATE TABLETS 5 MG, AND 10 MG |
PAR PHARMACEUTICAL, INC. |
4/26/02 |
| 6 |
75-660 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML PACKAGED IN 10 ML, 20 ML, AND 50 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
4/30/02 |
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Last Updated: April 25, 2006
Originator: OGC
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