FDA's ANDA Approvals（９月28日）
公開日時 2009/09/29 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Akorn |
Irinotecan HCl, 20 mg/mL inj. |
90-726 |
9/16/2009 |
| Glenmark |
Verapamil HCl, 240 mg extended-release tabs. |
78-906 |
9/17/2009 |
| Aurobindo |
Ribavirin, 200 mg tabs. |
79-111 |
9/17/2009 |
| Aurobindo |
Ribavirin, 200 mg caps. |
79-117 |
9/17/2009 |
| Orchid |
Zaleplon, 5 mg and 10 mg caps. |
90-374 |
9/17/2009 |
| Northstar |
Baclofen, 20 mg tabs. |
78-401 |
9/18/2009 |
| Northstar |
Baclofen, 10 mg tabs. |
78-504 |
9/18/2009 |
| Aurobindo |
Fluconazole, 50 mg/5 mL and 200 mg/5 mL oral suspension |
79-150 |
9/18/2009 |
| APP |
Sumatriptan succinate, EQ 4 mg base/0.5 mL (EQ 8 mg base/mL) and EQ 6 mg base/0.5 mL (EQ 12 mg base/mL) subcutaneous inj. |
79-240 |
9/18/2009 |
| Carlsbad |
Glimepiride, 1 mg, 2 mg and 4 mg tabs. |
77-911 |
9/22/2009 |
| APP |
Ifosfamide, 1 mg and 3 mg inj. |
90-181 |
9/22/2009 |
| Tentative Approvals |
| Par |
Fluvastatin sodium, 80 mg extended-release tabs. |
78-872 |
9/15/2009 |
| Sandoz |
Olmesartan medoxomil, 5 mg, 20 mg and 40 mg tabs. |
90-237 |
9/16/2009 |
| Generamedix |
Azithromycin, 500 mg inj. |
65-501 |
9/23/2009 |
（The Pink Sheet ９月28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