FDA's ANDA Approvals（７月19日）
公開日時 2010/07/21 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Vintage |
Ranitidine HCl, EQ 15 mg base/mL oral syrup |
78-890 |
7/1/2010 |
| Watson |
Tacrolimus, EQ 5 mg base caps. |
90-402 |
7/1/2010 |
| Glenmark |
Adapalene, 0.1% topical gel |
91-314 |
7/1/2010 |
| Dr. Reddy's |
Desloratadine, 2.5 mg and 5 mg orally disintegrating tabs. |
78-367 |
7/12/2010 |
| Matrix |
Nabumetone, 500 mg and 750 mg tabs. |
90-516 |
7/12/2010 |
| Glenmark |
Theophylline, 400 mg and 600 mg extended-release tabs. |
90-355 |
7/13/2010 |
| Mylan |
Bupropion HCl, 150 mg and 300 mg extended-release tabs. |
90-942 |
7/14/2010 |
| Sigmapharm |
Ergocalciferol, 50,000 IU caps. |
91-004 |
7/14/2010 |
| Tentative Approvals |
| Dr. Reddy's |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg and 60 mg caps. |
90-609 |
7/12/2010 |
(The Pink Sheet ７月19日号より） FDAと米国製薬企業の情報満載
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