|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
75-823 |
CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML; 1 ML FILL IN 2 ML SINGLE-DOSE VIALS |
GENSIA SICOR PHARMACEUTICALS, INC. |
1/2/03 |
2 |
76-162 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS |
PHARMACHEMIE B.V. |
1/14/03 |
3 |
76-196 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG |
ROXANE LABORATORIES, INC. |
1/14/03 |
4 |
76-270 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
ROXANE LABORATORIES, INC. |
1/14/03 |
5 |
76-215 |
BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE) |
ALTANA INC. |
1/15/03 |
6 |
75-746 |
CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG'ML; PACKAGED IN 1 ML AMPULES |
LUITPOLD PHARMACEUTICALS, INC. |
1/21/03 |
7 |
76-401 |
VINCRISTINE SULFATE INJECTION, USP 1 MG/ML; PACKAGED IN 5 MG/5 ML MULTIPLE- DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
1/24/03 |
8 |
75-360 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG |
TORPHARM |
1/29/03 |
9 |
76-072 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG |
GENEVA PHARMACEUTICALS, INC. |
1/30/03 |
10 |
76-279 |
PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG |
GENEVA PHARMACEUTICALS TECHNOLOGY CORP. |
1/30/03 |