FDA's ANDA Approvals（7月18日）
公開日時 2011/07/20 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| ACS |
Levofloxacin in dextrose 5% in plastic container, EQ 250 mg/50 mL (EQ 5 mg/ml), EQ 500 mg/100ml (EQ 5 mg/mL), EQ 750mg/150 mL (EQ 5 mg/mL) inj. |
90-343 |
7/7/2011 |
| Orchid Hlthcare |
Venlafaxine HCl., EQ 37.5 mg base, EQ 75 mg base, EQ 150 mg base extended release caps. |
91-123 |
7/11/2011 |
| Glenmark |
Ursodiol, 250 mg & 500 mg tabs. |
90-801 |
7/12/2011 |
| Lyne |
Dexamethasone, 0.5 mg/5 mL oral elixir |
90-891 |
7/12/2011 |
| Apotex |
Azithromycin, EQ 250 mg base tabs. |
65-507 |
7/13/2011 |
| Apotex |
Azithromycin, EQ 600 mg base tabs. |
65-508 |
7/13/2011 |
| Apotex |
Azithromycin, EQ 500 mg base tabs. |
65-509 |
7/13/2011 |
| Amide |
Letrozole, 2.5 mg tabs. |
90-292 |
7/13/2011 |
| Tentative Approvals |
|
|
|
| Wockhardt |
Duloxetine HCl, 20 mg, 30 mg and 60 mg delayed release caps. |
90-773 |
7/6/2011 |
| Roxane |
Cevimeline HCl, 30 mg caps. |
91-591 |
7/7/2011 |
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