FDA's ANDA Approvals（７月26日）
公開日時 2010/07/27 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Bedford |
Testosterone cypionate, 100 mg/mL and 200 mg/mL inj. |
90-387 |
7/15/2010 |
| Sun |
Tamsulosin HCl, 0.4 mg caps. |
90-931 |
7/15/2010 |
| Mylan |
Clonidine, 0.1 mg, 0.2 mg and 0.3 mg transdermal system |
76-166 |
7/16/2010 |
| Endo |
Mycophenolate mofetil, 500 mg tabs. |
90-606 |
7/16/2010 |
| Lannett |
Phentermine HCl, 30 mg caps. |
91-359 |
7/16/2010 |
| Synerx |
Isosulfan blue, 1% inj. |
90-874 |
7/20/2010 |
| Matrix |
Minocycline HCl, EQ 45 mg base, EQ 90 mg base and 135 mg base extended-release tabs. |
90-911 |
7/20/2010 |
| KVK |
Benzphetamine HCl, 50 mg tabs. |
90-968 |
7/20/2010 |
| Tentative Approvals |
| Torrent |
Montelukast sodium, 4 mg and 5 mg chewable tabs. |
90-984 |
7/16/2010 |
| Sandoz |
Rosuvastatin calcium, 5 mg, 10 mg, 20 mg and 40 mg tabs. |
79-171 |
7/19/2010 |
（The Pink Sheet ７月26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