FDA's ANDA Approvals(11月29日)
公開日時 2010/11/30 04:00
FDA's ANDA Approvals |
Applicant |
Active Ingredients |
Number |
Date Approved |
Dr. Reddy’s |
Zafirlukast, 10 mg and 20 mg tabs. |
90-372 |
11/18/2010 |
Micro |
Mefenamic acid, 250 mg caps. |
90-562 |
11/19/2010 |
Tentative Approvals |
Mylan |
Pantoprazole sodium, 20 mg and 40 mg delayed-release tabs. |
90-970 |
11/15/2010 |
Impax |
Duloxetine HCl, 30 mg and 60 mg delayed-release caps. |
90-669 |
11/18/2010 |
Mylan |
Eszopiclone, 1 mg, 2 mg and 3 mg tabs. |
91-151 |
11/18/2010 |
Sun |
Duloxetine HCl, 20 mg, 30 mg and 60 mg delayed-release caps. |
90-745 |
11/19/2010 |
(The Pink Sheet 11月29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