FDA's ANDA Approvals（12月6日）
公開日時 2010/12/07 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Ranbaxy |
Donepezil HCl, 5 mg and 10 mg tabs. |
76-786 |
11/26/2010 |
| Barr |
Donepezil HCl, 5 mg and 10 mg tabs. |
78-388 |
11/26/2010 |
| Synthon |
Levocetirizine dihydrochloride, 5 mg tabs. |
90-229 |
11/26/2010 |
| Sagent |
Midazolam HCl, EQ 1 mg base/mL and EQ 5 mg base/mL inj. |
90-315 |
11/29/2010 |
| APP |
Topotecan HCl, EQ 4 mg base/vial inj. |
91-089 |
11/29/2010 |
| Fresenius Kabi |
Topotecan HCl, EQ 4 mg base/vial inj. |
91-376 |
11/29/2010 |
| Watson |
Ciprofloxacin; ciprofloxacin HCl., 212.6 mg; EQ 287.5 mg base extended-release tabs. |
77-417 |
11/30/2010 |
| Watson |
Ciprofloxacin, 1,000 mg extended-release tabs. |
77-809 |
11/30/2010 |
| Actavis |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg and 1.5 mg tabs. |
91-254 |
11/30/2010 |
| Amneal |
Indomethacin, 75 mg extended-release caps. |
91-549 |
12/1/2010 |
| Tentative Approvals |
| Sun |
Donepezil HCl, 5 mg and 10 mg tabs. |
90-493 |
11/29/2010 |
| Apotex |
Epinastine HCl, 0.05 ophthalmic solution |
90-919 |
11/29/2010 |
| Matrix |
Abacavir sulfate, 60 mg tabs. |
200-733 |
11/29/2010 |
| Aurobindo |
Duloxetine HCl, 20 mg, 30 mg and 60 mg delayed-release caps. |
90-778 |
12/1/2010 |
（The Pink Sheet 12月6日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから