FDA’s ANDA Approvals（６月21日）
公開日時 2010/06/22 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Strides Arcolab |
Mycophenolate mofetil, 250 mg caps. |
90-055 |
6/10/2010 |
| Sagent Strides |
Sumatriptan succinate, EQ 6 mg base/0.5 mL (EQ 12 mg base/mL) subcutaneous inj. |
90-314 |
6/10/2010 |
| Strides Arcolab |
Mycophenolate mofetil, 500 mg tabs. |
90-456 |
6/10/2010 |
| Impax |
Oxymorphone HCl, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg extended-release tabs. |
79-087 |
6/14/2010 |
| Pharm Assoc |
Lorazepam, 2 mg/mL oral concentrate |
90-260 |
6/15/2010 |
| Sun |
Levetiracetam, 100 mg/mL inj. |
90-754 |
6/16/2010 |
| Tentative Approvals |
| Pharmaforce |
Epinastine HCl, 0.05% ophthalmic solution |
90-951 |
6/15/2010 |
（The PInk Sheet ６月21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