FDA's ANDA Approvals （12月７日）
公開日時 2009/12/08 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Matrix |
Lansoprazole, 15 mg and 30 mg delayed-release pellets caps. |
90-763 |
11/10/2009 |
| Paddock |
Ciclopirox, 1% topical shampoo |
90-490 |
11/24/2009 |
| The PharmaNetwork |
Methadone HCl, 10 mg tabs. |
90-635 |
11/25/2009 |
| Vintage |
Divalproex sodium, EQ 125 mg, EQ 250 mg and EQ 500 mg valproic acid delayed-release tabs. |
90-210 |
11/30/2009 |
| Tentative Approvals |
| Sandoz |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-018 |
11/25/2009 |
| Sun |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-020 |
11/25/2009 |
| Mylan |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-021 |
11/25/2009 |
| Teva |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-022 |
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