FDA's ANDA Approvals（10月10日）
公開日時 2011/10/14 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Anchen |
Alprazolam 0.5 mg, 1 mg, 2 mg, 3 mg extended release tabs. |
78-469 |
9/29/2011 |
| Apotex |
Levofloxacin 250 mg, 500 mg, 750 mg tabs. |
90-787 |
9/29/2011 |
| Onco |
Paclitaxel 6 mg/ml inj |
91-540 |
9/29/2011 |
| Sagent Strides |
Clindamycin EQ 150 mg base/ml inj. |
90-108 |
9/30/2011 |
| Sagent Strides |
Clindamycin EQ 150 mg base/ml inj. |
90-109 |
9/30/2011 |
| Acic Fine Chems |
Nafcillin Sodium EQ 1gm base, EQ 2 gm base inj. |
90-560 |
10/3/2011 |
| Anchen |
Levetiracetam 500mg, 750mg extended release tabs. |
91-360 |
10/4/2011 |
| Tentative Approvals |
| Teva |
Efavirenz/ Emtricitabine/Tenofovir Disoproxil Fumarate 600 mg/200 mg/300 mg tabs. |
91-215 |
9/30/2011 |
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