FDA's ANDA Approvals（9月19日）
公開日時 2011/09/26 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Watson |
Levetiracetam 500 mg,750 mg, Extended Release tabs. |
91-093 |
09/12/2011 |
| Apotex |
Levetiracetam 500 mg,750 mg, Extended Release tabs. |
91-261 |
09/12/2011 |
| Mutual |
Levetiracetam 500 mg,750 mg, Extended Release tabs. |
91-258 |
09/12/2011 |
| Par |
Levetiracetam 500 mg,750 mg, Extended Release tabs. |
91-291 |
09/12/2011 |
| Lupin |
Levetiracetam 500 mg,750 mg, Extended Release tabs. |
91-399 |
09/12/2011 |
| Teva |
Levetiracetam 500 mg,750 mg, Extended Release tabs. |
91-430 |
09/12/2011 |
| Actavis Elizabeth |
Levetiracetam 500 mg,750 mg, Extended Release tabs. |
91-557 |
09/12/2011 |
| Lupin |
Eszopiclone 1 mg, 2 mg, 3 mg, tabs. |
91-124 |
09/13/2011 |
| Tentative Approvals |
| Matrix |
Lamivudine/ Tenofovir Disoproxil Fumarate/ Nevirapine 300 mg/300 mg/200 mg tabs. |
202-171 |
9/8/2011 |
| Mylan |
Irbesartan 75 mg,150 mg, 300 mg tabs. |
200-461 |
9/12/2011 |
| Par |
Travoprost 0.004%, ophthalmic sol. |
91-340 |
9/13/2011 |
（The Pink Sheet 9月19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