FDA's ANDA Approvals（２月14日）
公開日時 2011/02/17 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sun |
Galantamine hydrobromide, EQ 8 mg base, EQ 16 mg base and EQ 24 mg base extended-release caps. |
90-178 |
2/2/2011 |
| Taro |
Risperidone, 1 mg/mL oral solution |
90-347 |
2/7/2011 |
| Actavis |
Pantoprazole sodium, EQ 20 mg base and EQ 40 mg base delayed-release tabs. |
90-797 |
2/7/2011 |
| Amneal |
Dextromethorphan hydrobromide/promethazine HCl, 15 mg/5 mL and 6.25 mg/5 mL syrup |
90-575 |
2/8/2011 |
| Mallinckrodt |
Fentanyl, 25 mcg, 50 mcg, 75 mcg and 100 mcg transdermal system |
77-154 |
2/9/2011 |
| Hi Tech |
Levofloxacin, 0.5% ophthalmic solution |
76-826 |
2/10/2011 |
| Tentative Approvals |
| Pharmaforce |
Latanoprost, 0.005% ophthalmic solution |
200-925 |
2/1/2011 |
| Sandoz |
Duloxetine HCl, 20 mg, 30 mg and 60 mg delayed-release caps. |
90-775 |
2/2/2011 |
| Mylan |
Doxercalciferol, 2 mcg/mL inj. |
91-101 |
2/3/2011 |
| Sandoz |
Donepezil HCl, 5 mg and 10 mg orally disintegrating tabs. |
91-198 |
2/8/2011 |
| Sandoz |
Tolterodine tartrate, 1 mg and 2 mg tabs. |
78-419 |
2/9/2011 |
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