FDA's ANDA Approvals（2月7日）
公開日時 2011/02/10 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sandoz |
Oxaliplatin, 50 mg/10 mL (5 mg/mL) and 100 mg/20 mL (5 mg/mL) IV (infusion) inj. |
78-817 |
1/24/2011 |
| Mylan |
Nisoldipine, 8.5 mg, 17 mg, 25.5 mg and 34 mg extended-release tabs. |
91-001 |
1/26/2011 |
| Sagent |
Topotecan HCl, EQ 4 mg base/vial inj. |
91-284 |
1/26/2011 |
| West Ward |
Clonidine HCl, 1 mg/10 mL (0.1 mg/mL) and 5 mg/10 mL (0.5 mg/mL) inj. |
200-300 |
1/26/2011 |
| Zydus |
Glipizide/metformin HCl, 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg tabs. |
78-905 |
1/31/2011 |
| Amneal |
Ondansetron HCl, EQ 4 mg base/5 mL oral solution |
91-483 |
1/31/2011 |
| Zydus |
Tramadol HCl, 50 mg tabs. |
90-404 |
1/31/2011 |
| Epic |
Phentermine HCl, 37.5 mg tabs. |
200-272 |
1/31/2011 |
| Tentative Approvals |
| Aurobindo |
Famciclovir, 125 mg, 250 mg and 500 mg tabs. |
91-114 |
1/26/2011 |
| Sandoz |
Epinastine HCl, 0.05% ophthalmic solution |
90-950 |
1/27/2011 |
| Dr. Reddy’s |
Clopidogrel, 300 mg tabs. |
91-023 |
1/27/2011 |
| Hikma |
Levofloxacin, 250 mg, 500 mg and 750 mg tabs. |
78-767 |
1/31/2011 |
| Dr. Reddy’s |
Amlodipine besylate/benazepril HCl, 5 mg base/40 mg and 10 mg base/40 mg caps. |
90-149 |
1/31/2011 |
| Pharmaforce |
Latanoprost, 0.005% ophthalmic solution |
200-925 |
2/1/2011 |
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