| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-745 |
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS
5 MG, 10 MG, AND 15 MG |
IMPAX LABORATORIES, INC. |
2/1/2005 |
| 2 |
76-594 |
MODAFINIL TABLETS 100 MG AND 200 MG |
MYLAN PHARMACEUTICALS, INC. |
2/9/2005 |
| 3 |
76-854 |
LEVOFLOXACIN INJECTION IN DEXTROSE 5%
(PREMIX) 5 MG (BASE)/ML; PACKAGED IN 250 MG (BASE)/50 ML AND
500 MG (BASE)/100 ML SINGLE-USE PLASTIC CONTAINERS |
SICOR PHARMACEUTICALS, INC. |
2/10/2005 |
| 4 |
76-839 |
LEVOFLOXACIN INJECTION 25 MG (BASE)/ML;
PACKAGED IN 500 MG (BASE)/20 ML AND 750 MG (BASE)/30 ML
SINGLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
2/10/2005 |
| 5 |
76-786 |
DONEPEZIL HYDROCHLORIDE TABLETS 5 MG 10 MG |
RANBAXY LABORATORIES LIMITED |
2/23/2005 |
| 6 |
76-993 |
CIPROFLOXACIN INJECTION, USP 10 MG/ML;
PACKAGED IN 1200 MG/120 ML PHARMACY BULK PACKAGES |
BEDFORD LABORATORIES |
2/25/2005 |
| 7 |
77-097 |
LEVOFLOXACIN TABLETS 750 MG |
MYLAN PHARMACEUTICALS, INC. |
2/25/2005 |
