FDA's ANDA Approvals(12月14日）
公開日時 2009/12/15 04:00
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Hikma |
Fosphenytoin sodium, EQ 50 mg phenytoin na/mL inj. |
78-765 |
12/2/2009 |
| OHM Labs |
Chloroquine phosphate, EQ 300 mg base tabs. |
90-249 |
12/3/2009 |
| OHM Labs |
Chloroquine phosphate, EQ 150 mg base tabs. |
90-610 |
12/3/2009 |
| Mylan |
Levetiracetam, 1 gm tabs. |
90-261 |
12/8/2009 |
| Lannett |
Hydromorphone HCl, 8 mg tabs. |
77-471 |
12/9/2009 |
| Lannett |
Hydromorphone HCl, 2 mg and 4 mg tabs. |
78-439 |
12/9/2009 |
| Actavis |
Paclitaxel, 6 mg/mL inj. |
90-130 |
12/9/2009 |
| Amneal |
Tramadol HCl/acetaminophen, 37.5 mg/325 mg tabs. |
90-485 |
12/9/2009 |
| Tentative Approvals |
| Mylan |
Levofloxacin, 250 mg, 500 mg and 750 mg tabs. |
90-063 |
12/4/2009 |
| Hikma |
Rosiglitazone maleate, 2 mg, 4 mg and 8 mg tabs. |
78-658 |
12/8/2009 |
| Teva |
Gemcitabine, 2 g inj. |
90-644 |
12/8/2009 |
（The Pink Sheet 12月14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