FDA's ANDA Approvals（8月29日）
公開日時 2011/08/30 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Breckenridge |
Levetiracetam 250 mg,500 mg,750 mg,1 gm tabs. |
90-511 |
8/19/2011 |
| Insys Therap |
Dronabinol 2.5 mg,5 mg,10 mg caps. |
78-501 |
8/19/2011 |
| Teva |
Levocetirizine Dihydrochloride 5 mg tabs. |
90-199 |
8/22/2011 |
| Nexgen |
Acetaminophen/Butalbital 300 mg/50 mg tabs. |
90-956 |
8/23/2011 |
| Tentative Approvals// |
| Perrigo |
Clobetasol Propionate 0.05% shampoo |
90-974 |
8/18/2011 |
| Mutual |
Levetiracetam 500 mg,750 mg extended release tabs. |
91-285 |
8/18/2011 |
| Dr. Reddy |
Fexofenadine HCL/Pseudoephedrine HCL 60 mg/120 mg extended release tabs. |
76-667 |
8/19/2011 |
| Par |
Travoprost 004% ophthalmic sol. |
91-341 |
8/19/2011 |
| Mylan |
Ezetimibe/Simvastatin 10 mg/10 mg,10 mg/20 mg,10 mg/40 mg,10 mg/80 mg tabs. |
200-082 |
8/19/2011 |
| Par |
Levetiracetam 500 mg,750 mg extended release tabs. |
91-291 |
8/22/2011 |
| Teva |
Levetiracetam 500 mg,750 mg tabs. |
91-430 |
8/22/2011 |
（The Pink Sheet 8月29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