 |
Tentative
Approvals - January 2004
| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-315 |
TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG |
BARR LABORATORIES, INC. |
1/5/2004 |
| 2 |
76-335 |
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.180MG/0.035 MG, 0.215 MG/0.035 MG,
0.25 MG/0.035 MG PACKAGED AS A TRIPHASIC REGIMEN (28-DAY CYCLE) |
ANDRX PHARMACEUTICALS, LLC |
1/6/2004 |
| 3 |
76-597 |
MODAFINIL TABLETS 100 MG, AND 200 MG |
BARR LABORATORIES, INC. |
1/7/2004 |
| 4 |
75-815 |
LORATADINE SYRUP 5 MG/5 ML |
MORTON GROVE PHARMACEUTICALS, INC. |
1/16/2004 |
| 5 |
76-430 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG |
MYLAN PHARMACEUTICALS, INC. |
1/23/2004 |
| 6 |
76-622 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
BAUSCH & LOMB, INC. |
1/23/2004 |
| 7 |
75-913 |
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 150 MG (TWICE-A-DAY DOSING) |
IMPAX LABORATORIES, INC. |
1/28/2004 |
| 8 |
76-754 |
CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
BAUSCH & LOMB, INC. |
1/30/2004 |
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Date created: 2/9/2004 |
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