FDA's ANDA Approvals（9月12日）
公開日時 2011/09/14 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Accord |
Tacrolimus 0.5 mg, 1 mg, 5 mg caps. |
91-195 |
8/31/2011 |
| Anitbioticos Brasil |
Cefoxitin EQ 10 gm base/vial inj. |
65-464 |
8/31/2011 |
| Anitbioticos Brasil |
Cefoxitin EQ 1 gm, 2 gm base/vial inj. |
65-467 |
8/31/2011 |
| Sagent |
Haloperidol Lactate EQ 5 mg base/ML inj. |
91-637 |
9/2/2011 |
| Roxane |
Quetiapine Fumerate 25 mg tabs |
90-120 |
9/6/2011 |
| Sagent |
Haloperidol Lactate EQ 5 mg base/ML inj. |
200-742 |
9/7/2011 |
| Tentative Approvals |
| Apotex |
Riluzole 50 mg tabs. |
91-300 |
9-7-2011 |
（The Pink Sheet 9月12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