Tentative Approvals - March 2001
| |
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
75-478 |
NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP 0.5MG/0.035MG 0.75MG/0.035MG 1MG/0.035MG |
BARR LABORATORIES INC. |
3/9/01 |
| 2 |
75-707 |
FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) |
APOTHECON INC. |
3/13/01 |
| 3 |
75-659 |
NIFEDIPINE EXTENDED-RELEASE TABLETS 60 MG |
ELAN PHARMACEUTICAL RESEARCH CORPORATION |
3/20/01 |
| 4 |
75-590 |
NABUMETONE TABLETS 500 MG 750 MG |
INVAMED INC. |
3/21/01 |
| 5 |
75-298 |
FLUTAMIDE CAPSULES, USP 125 MG |
TEVA PHARMACEUTICALS USA |
3/23/01 |
| 6 |
75-818 |
FLUTAMIDE CAPSULES, USP 125 MG |
EON LABS MANUFACTURING, INC. |
3/26/01 |
| 7 |
74-253 |
BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MG |
DANBURY PHARMACAL, INC. |
3/28/01 |
| 8 |
75-786 |
FAMOTIDINE TABLETS, USP 20 MG 40 MG |
WOCKHARDT AMERICAS, INC. |
3/28/01 |
| 9 |
75-747 |
CIPROFLOXACIN TABLETS, USP 250 MG 500 MG 750 MG |
RANBAXY PHARMACEUTICALS, INC. |
3/30/01
|
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Last Updated: September 10, 200125 Apr 2006 08:48:15 -0400
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