FDA's ANDA Approvals（8月15日）
公開日時 2011/08/18 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Glenmark Generics |
Verapamil HCl 120 mg & 180 mg extended release tabs |
90-700 |
Aug. 2, 2011 |
| Apotex |
Levetiracetam 100 mg solution |
90-187 |
Aug. 5, 2011 |
| Innopharma |
Levetiracetam 500 mg/ml inj. |
91-485 |
Aug. 8, 2011 |
| Tentative Approvals |
| Anchen |
Levetiracetam 500 mg & 750 mg extended release tabs |
91-360 |
Aug. 3, 2011 |
| Teva |
Pregabalin 25 mg & 50 mg caps. |
91-219 |
Aug. 4, 2011 |
| Teva |
Pregabalin 75 mg,100 mg,150 mg, 200mg, 225 mg, & 300 mg caps. |
91-224 |
Aug. 4, 2011 |
| Watson |
Rosuvastatin Zinc 5 mg, 10 mg, 20 mg, & 40mg tabs. |
202-172 |
Aug. 4, 2011 |
| Dr.Reddys |
Paricalcitol 1 mcg, 2 mcg, & 4 mcg caps |
91-412 |
Aug. 5, 2011 |
| Matrix |
Candesartan Cilexetil / HydroCloridethaizide 16 mg/12.5 mg, 32 mg/12.5 mg, 32 mg/25 mg caps |
09-704 |
Aug. 9, 2011 |
| Sandoz |
Montelukast Sodium 4 mg, 5 mg chewable tabs. |
91-414 |
Aug. 9, 2012 |
（The Pink Sheet 8月15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