FDA's ANDA Approvals(10月24日)
公開日時 2011/10/27 04:00
FDA’s ANDA Approvals |
Applicant |
Active Ingredients |
Number |
Date Approved |
Hikma |
Levetiracetam 500 mg/ml (100 mg/ml) inj./iv infusion |
90-981 |
10/13/2011 |
Lupin |
Levetiracetam 100 mg/ml oral sol. |
90-893 |
10/17/2011 |
Identi |
Fluocinolone acetonide 0.1% oil/drops Otic |
91-306 |
10/17/2011 |
Sagent |
Bupivacaine HCl 0.5%,0.25%,0.75% inj. |
91-487 |
10/18/2011 |
Sagent |
Bupivacaine HCl 0.25%,0.5% inj. |
91-503 |
10/18/2011 |
(The Pink Sheet 10月24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