Tentative Approvals - February 2002
|
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-067 |
MOMETASONE FUROATE OINTMENT, USP 0.1% |
CLAY-PARK LABS, INC. |
2/1/02 |
2 |
75-928 |
CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
NOVEX PHARMA |
2/4/02 |
3 |
76-059 |
LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG |
WATSON LABORATORIES, INC. |
2/5/02 |
4 |
75-504 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG |
TEVA PHARMACEUTICALS USA |
2/8/02 |
5 |
75-890 |
GLYBURIDE TABLETS, USP (MICRONIZED) 1.5 MG, 3 MG, AND 6 MG |
AL-HIKMA PHARMACEUTICALS |
2/8/02 |
6 |
75-181 |
PRENISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG(BASE)/5 ML |
WE PHARMACEUTICALS, INC. |
2/13/02 |
7 |
75-868 |
FENOFIBRATE CAPSULES (MICRONIZED) 67 MG, 134 MG, AND 200 MG |
IMPAX LABORATORIES, INC. |
2/20/02 |
8 |
75-873 |
MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML |
ROXANE LABORATORIES, INC. |
2/25/02 |
9 |
76-176 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
ALPHAPHARM PTY LTD. |
2/25/02 |
10 |
76-153 |
PAMIDRONATE DISODIUM INJECTION 3 MG/ML (30 MG/10 ML SINGLE-USE VIAL), 9 MG/ML (90 MG/10 ML SINGLE-USE VIAL |
GENSIA SICOR PHARMACEUTICALS, INC. |
2/28/02 |
11 |
76-154 |
LORATADINE TABLETS 10 MG |
GENPHARM INC. |
2/28/02 |
Back to Top
Back to Approvals
FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
HTML by PKS, TA
|