Tentative Approvals - May 2002
|
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-223 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG |
GENEVA PHARMACEUTICALS TECHNOLOGY CORPOR |
5/6/02 |
2 |
76-018 |
AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (3 ML VIAL) |
BEDFORD LABORATORIES |
5/7/02 |
3 |
76-104 |
ITRACONAZOLE CAPSULES 100 MG |
EON LABS MANUFACTURING, INC. |
5/8/02 |
4 |
76-123 |
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML |
PHARMACEUTICAL ASSOCIATES, INC. |
5/13/02 |
5 |
76-231 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
ALCON UNIVERSAL, LTD. |
5/13/02 |
6 |
76-056 |
PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG |
TEVA PHARMACEUTICALS USA |
5/15/02 |
7 |
76-235 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG PER SINGLE-DOSE VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/22/02 |
8 |
75-989 |
LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 10 MG/240 MG (24-HOUR FORMULATION) |
IMPAX LABORATORIES, INC. |
5/24/02 |
9 |
76-036 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
PAR PHARMACEUTICAL, INC. |
5/24/02 |
10 |
76-050 |
LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 5 MG/120 MG (12-HOUR FORMULATION) |
IMPAX LABORATORIES, INC. |
5/29/02 |
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