|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-214 |
SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG, 120 MG, AND 160 MG |
TORPHARM |
3/5/2003 |
2 |
76-349 |
FLUDARABINE PHOSPHATE FOR INJECTION 50 MG/VIAL |
GENSIA SICOR PHARMACEUTICALS, INC. |
3/12/2003 |
3 |
75-728 |
LORATADINE SYRUP (OTC) 10 MG/10 ML |
L. PERRIGO COMPANY |
3/12/2003 |
4 |
76-269 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG |
TEVA PHARMACEUTICALS USA |
3/25/2003 |
5 |
76-128 |
OFLOXACIN OTIC SOLUTION 0.3% |
BAUSCH & LOMB PHARMACEUTICALS, INC. |
3/31/2003 |