|
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 |