FDA's ANDA Approvals（3月14日）
公開日時 2011/03/17 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Amneal |
Meclizine HCl, 12.5 mg, 25 mg and 50 mg tabs. |
201-451 |
2/23/2011 |
| Vistapharm |
Nystatin, 100,000 units/mL oral suspension |
65-422 |
3/7/2011 |
| Amneal |
Fluconazole, 50 mg, 100 mg, 150 mg and 200 mg tabs. |
78-423 |
3/7/2011 |
| Pharmaforce |
Trimethobenzamide HCl, 100 mg/mL inj. |
91-329 |
3/8/2011 |
| Pharmaforce |
Trimethobenzamide HCl, 100 mg/mL inj. |
91-330 |
3/8/2011 |
| Tentative Approvals |
|
|
|
| Sandoz |
Escitalopram oxalate, 5 mg, 10 mg and 20 mg tabs. |
78-467 |
3/3/2011 |
| Cipla |
Abacavir sulfate, 60 mg tabs. |
22-547 |
3/4/2011 |
| Cipla |
Lamivudine/tenofovir disoproxil fumarate, 300 mg/300 mg tabs. |
200-623 |
3/4/2011 |
| Matrix |
Amlodipine besylate/olmesartan medoxomil, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40mg tabs. |
90-398 |
3/7/2011 |
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