FDA's ANDA Approvals（７月13日）
公開日時 2009/07/14 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Orchid |
Amlodipine besylate, EQ 2.5 mg base, EQ 5 mg base and EQ 10 mg base tabs. |
78-453 |
4/2/2009 |
| Teva |
Bicalutamide, 50 mg tabs. |
76-932 |
7/6/2009 |
| Synthon |
Bicalutamide, 50 mg tabs. |
77-973 |
7/6/2009 |
| Kudco |
Bicalutamide, 50 mg tabs. |
77-995 |
7/6/2009 |
| Sandoz |
Bicalutamide, 50 mg tabs. |
78-575 |
7/6/2009 |
| Accord |
Bicalutamide, 50 mg tabs. |
78-917 |
7/6/2009 |
| Zydus |
Bicalutamide, 50 mg tabs. |
79-089 |
7/6/2009 |
| Sun |
Bicalutamide, 50 mg tabs. |
79-110 |
7/6/2009 |
| Mylan |
Bicalutamide, 50 mg tabs. |
79-185 |
7/6/2009 |
| Tentative Approvals |
| Ivax |
Escitalopram oxalate, EQ 5 mg base, EQ 10 mg base and EQ 20 mg base tabs. |
76-765 |
7/1/2009 |
| Par |
Tramadol HCl, 100 mg and 200 mg extended-release tabs. |
78-783 |
7/8/2009 |
(The Pink Sheet ７月13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