Drug Information |
ANDA Number | Drug Name | Applicant | Tentative Approval Date | |
---|---|---|---|---|
1 | 75-706 | LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS 10 MG/240 MG (24-HOUR FORMULATION) | ANDRX PHARMACEUTICALS, LLC | 7/9/02 |
2 | 75-919 | MOMETASONE FUROATE TOPICAL SOLUTION, USP 0.1% | ALTANA INC. | 7/10/02 |
3 | 76-171 | MOMETASONE FUROATE CREAM, USP 0.1% | ALTANA INC. | 7/10/02 |
4 | 76-179 | TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE) | ANDRX PHARMACEUTICALS, INC. | 7/10/02 |
5 | 76-217 | AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (PACKAGED IN 150 MG/3 ML VIALS) | BIONICHE PHARMA (CANADA) LTD. | 7/10/02 |
6 | 76-088 | AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (PACKAGED IN 150 MG/3 ML SINGLE-USE VIALS); PRESERVATIVE-FREE | BEN VENUE LABORATORIES, INC. | 7/17/02 |
7 | 76-173 | RILUZOLE TABLETS 50 MG | IMPAX LABORATORIES, INC. | 7/17/02 |
8 | 75-711 | ALENDRONATE SODIUM TABLETS 5 MG, 10 MG, AND 40 MG | IVAX PHARMACEUTICALS, INC. | 7/24/02 |
9 | 75-923 | OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG | ENDO PHARMACEUTICALS, INC. | 7/31/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: August 9, 2002
Originator: OGC
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