FDA's ANDA Approvals（12月20日）
公開日時 2010/12/24 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Silarx |
Ranitidine HCl, EQ 15 mg base/mL oral syrup |
91-288 |
12/9/2010 |
| Actavis |
Oxymorphone HCl, 7.5 mg and 15 mg extended-release tabs. |
79-046 |
12/13/2010 |
| Amneal |
Promethazine HCl, 12.5 mg, 25 mg and 50 mg tabs. |
91-179 |
12/13/2010 |
| Alembic |
Venlafaxine HCl, EQ 25 mg base, EQ 37.5 mg base, EQ 50 mg base, EQ 75 mg base and EQ 100 mg base |
78-932 |
12/14/2010 |
| Vintage |
Levetiracetam, 250 mg, 500 mg, 750 mg and 1 gm tabs. |
91-491 |
12/14/2010 |
| Tentative Approvals |
| Accord |
Quetiapine fumarate, 150 mg, 200 mg, 300 mg and 400 mg extended-release tabs. |
90-681 |
12/14/2010 |
（The Pink Sheet 12月20日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから