FDA's ANDA Approvals（２月21日）
公開日時 2011/02/22 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Bioniche |
Octreotide acetate, EQ 0.05 mg base/mL, EQ 0.1 mg base/mL and EQ 0.5 mg base/mL inj. |
79-198 |
2/10/2011 |
| Zydus |
Gabapentin, 600 mg and 800 mg tabs. |
78-926 |
2/11/2011 |
| Actavis Elizabeth |
Mirtazapine, 15 mg, 30 mg and 45 mg orally-disintegrating tabs. |
77-959 |
2/14/2011 |
| Matrix |
Gabapentin, 100 mg, 300 mg and 400 mg caps. |
90-158 |
2/14/2011 |
| Accord |
Levetiracetam, 250 mg, 500 mg 750 mg and 1 gm tabs. |
90-843 |
2/14/2011 |
| Marksans |
Naproxen, 250 mg, 375 mg and 500 mg tabs. |
91-416 |
2/14/2011 |
| Sun |
Naratriptan, EQ 2.5 mg base tabs. |
91-552 |
2/14/2011 |
| Glenmark |
Lithium carbonate, 450 mg extended-release tabs. |
91-616 |
2/14/2011 |
| Teva |
Oxymorphone HCl, 5 mg and 10 mg tabs. |
91-443 |
2/15/2011 |
| Tentative Approvals |
|
|
|
| Hikma |
Levofloxacin, 250 mg, 500 mg and 750 mg tabs. |
78-767 |
2/10/2011 |
| Sandoz |
Argatroban, 125 mg inj. |
201-743 |
2/10/2011 |
| Mylan |
Abacavir sulfate, 300 mg tabs. |
91-294 |
2/15/2011 |
| Zydus |
Irbesartan/hydrochlorothiazide, 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg tabs. |
90-815 |
2/16/2011 |
| Cipla |
Abacavir Sulfate, 20 mg oral solution |
78-348 |
2/16/2011 |
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