FDA's ANDA Approvals（12月13日）
公開日時 2010/12/14 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Unique |
Diclofenac sodium, 25 mg and 50 mg delayed-release tabs. |
90-066 |
12/1/2010 |
| Three Rivers |
Topotecan HCl, EQ 4 mg base/vial inj. |
91-199 |
12/1/2010 |
| Actavis |
Topotecan HCl, 4 mg inj. |
90-620 |
12/2/2010 |
| West Ward |
Milrinone lactate, 1 mg/mL inj. |
77-966 |
12/3/2010 |
| Anchen |
Zolpidem tartrate, 12.5 mg extended-release tabs. |
78-148 |
12/3/2010 |
| Sandoz |
Desloratadine, 5 mg tabs. |
78-364 |
12/3/2010 |
| Vintage |
Risperidone, 1 mg/mL oral solution |
79-158 |
12/3/2010 |
| Mylan |
Hydralazine HCl, 10 mg, 25 mg, 50 mg and 100 mg tabs. |
90-413 |
12/8/2010 |
| Strides Arcolab |
Lidocaine HCl, 0.5% and 1% inj. |
91-056 |
12/8/2010 |
| Tentative Approvals |
| Bedford |
Levofloxacin/dextrose, 5% (5 mg/mL) inj. |
90-305 |
12/1/2010 |
| Orchid |
Rivastigmine tartrate, EQ 1.5 mg base, EQ 3 mg base, EQ 4.5 mg and EQ 6 mg base caps. |
90-879 |
12/8/2010 |
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