FDA's ANDA Approvals（11月１日）
公開日時 2010/11/05 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Watson |
Amlodipine besylate/benazepril HCl, 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg caps. |
77-890 |
10/14/2010 |
| Teva |
Lansoprazole, 15 mg 30 mg delayed-release, orally disintegrating tabs. |
78-730 |
10/15/2010 |
| Dr. Reddy’s Labs |
Lansoprazole, 15 mg and 30 mg delayed-release pellets caps. |
91-269 |
10/15/2010 |
| Par |
Propafenone HCl, 225 mg, 325 mg and 425 mg extended-release caps. |
78-540 |
10/18/2010 |
| Sandoz |
Piperacillin/tazobactam, EQ 2 gm base/vial/EQ 250 mg base/vial, EQ 3 gm base/vial/EQ 375 mg base/vial and EQ 4 gm base/vial/EQ 500 mg base/vial inj. |
65-362 |
10/21/2010 |
| Sandoz |
Piperacillin/tazobactam, EQ 2 gm base/vial/EQ 250 mg base/vial, EQ 3 gm base/vial/EQ 375 mg base/vial and EQ 4 gm base/vial/EQ 500 mg base/vial inj. |
65-363 |
10/21/2010 |
| Lupin |
Desloratadine, 5 mg tabs. |
78-352 |
10/25/2010 |
| APP |
Metoprolol tartrate, 1 mg/mL inj. |
91-045 |
10/25/2010 |
| Glenmark |
Trandolapril/verapamil HCl, 2 mg/180 mg, 1 mg/240 mg, 2 mg/240 mg and 4 mg/240 mg extended-release tabs. |
79-135 |
10/27/2010 |
| Alembic |
Theophylline, 300 mg and 450 mg extended-release tabs. |
90-430 |
10/27/2010 |
| Cipla |
Zidovudine, 300 mg tabs. |
90-561 |
10/27/2010 |
| Bedford |
Melphalan HCl, EQ 50 mg base/vial inj. |
90-303 |
10/28/2010 |
| West Ward |
Progesterone, 500 mg/10 mL inj. |
91-033 |
10/28/2010 |
| Tentative Approvals |
| Glenmark |
Rosuvastatin calcium, 5 mg, 10 mg, 20 mg and 40 mg tabs. |
79-172 |
10/14/2010 |
| Torrent |
Alfuzosin HCl, 10 mg extended-release tabs. |
79-054 |
10/19/2010 |
| Wockhardt |
Fexofenadine HCl/pseudoephedrine HCl, 60 mg/120 mg extended-release tabs. |
79-115 |
10/19/2010 |
| Alembic |
Irbesartan, 75 mg, 150 mg and 300 mg tabs. |
91-236 |
10/27/2010 |
| Apotex |
Azithromycin, 250 mg tabs. |
65-507 |
10/28/2010 |
| Apotex |
Azithromycin, 500 mg tabs. |
65-509 |
10/28/2010 |
（The Pink Sheet 11月1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