First-Time Generics - April 2003
|
Generic Drug Name |
Generic Manufacturer |
Brand Name |
Approval Date |
1 |
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 120 MG, 180 MG, 240 MG,
300 MG, AND 360 MG (ONCE-A-DAY DOSAGE) |
ANDRX PHARMACEUTICALS, L.L.P. |
TIAZAC EXTENDED-RELEASE CAPSULES |
4/10/2003 |
2 |
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MG |
TEVA PHARMACEUTICALS USA |
VICOPROFEN TABLETS |
4/11/2003 |
3 |
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP EQ. TO 10 MG DEXAMETHASONE
PHOSPHATE/ML (PRESERVATIVE-FREE) |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP |
4/11/2003 |
4 |
MINOCYCLINE HYDROCHLORIDE TABLETS, USP 50 MG (BASE), 75 MG (BASE), AND 100 MG (BASE) |
PAR PHARMACEUTICAL, INC. |
MINOCIN TABLETS |
4/16/2003 |
5 |
NAPROXEN SODIUM EXTENDED-RELEASE TABLETS 375 MG (BASE) |
ANDRX PHARMACEUTICALS, LLC |
NAPRELAN EXTENDED-RELEASE TABLETS |
4/23/2003 |
6 |
CARBINOXAMINE MALEATE ORAL SOLUTION 4 MG/5 ML |
MIKART, INC. |
CLISTIN ELIXIR |
4/25/2003 |
7 |
DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML; SINGLE-DOSE AMPULES |
PADDOCK LABORATORIES, INC. |
D.H.E. 45 INJECTION |
4/28/2003 |
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FDA/Center for Drug Evaluation and Research
Last Updated: May 1, 2003
Originator: OTCOM/OGD
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