| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-739 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TABLETS 10 MG/12.5 MG and 20 MG/12.5 MG |
RANBAXY PHARMACEUTICALS, INC. |
9/1/2004 |
| 2 |
76-874 |
LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750
MG |
RANBAXY LABORATORIES LIMITED |
9/9/2004 |
| 3 |
76-537 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400
MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
9/20/2004 |
| 4 |
76-581 |
CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10
MG |
TEVA PHARMACEUTICALS USA |
9/21/2004 |
| 5 |
76-475 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS 37.5 MG/325 MG |
KALI LABORATORIES |
9/22/2004 |
| 6 |
76-992 |
CIPROFLOXACIN INJECTION, USP 10 MG/ML;
PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
9/23/2004 |
| 7 |
76-872 |
HALOBETASOL PROPIONATE OINTMENT 0.05% |
AGIS INDUSTRIES (1983) LTD. |
9/24/2004 |
| 8 |
76-277 |
RIBAVIRIN CAPSULES 200 MG |
TEVA PHARMACEUTICALS USA |
9/24/2004 |
| 9 |
76-818 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
COBALT PHARMACEUTICALS, INC. |
9/27/2004 |
| 10 |
76-869 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 750 MG |
ANDRX PHARMACEUTICALS LLC |
9/29/2004 |
