FDA's ANDA Approvals（8月22日）
公開日時 2011/08/24 04:00
| FDA’s ANDA Approvals |
|
|
|
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sun Global |
Finasteride 5 mg tabs |
90-507 |
8/16/11 |
| Accord |
Naltrexone HCl 50 mg tabs |
91-205 |
8/17/11 |
| Tentative Approvals |
| Sagent |
Ropivacaine HCL 2 mg/ml, 5 mg/ml, 7.5 mg/ml,10 mg/ml inj. |
90-318 |
2008/12/11 |
| Wockhardt |
Fexofenadine HCl 30 mg,60 mg,180 mg tabs |
79-112 |
8/16/11 |
| Teva |
Emtricitabine/Tenofovir Disoproxil Fumarate 200 mg/300 mg tabs |
90-894 |
8/16/11 |
| Apotex |
Levetiracetam 500 mg,750 mg extended release tabs |
91-261 |
8/16/ 11 |
（The Pink Sheet 8月22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