FDA’s ANDA Approvals
Executive Summary
Generic drug approvals and tentative approvals for mid-January.
|
Applicant |
Active Ingredients |
Number |
Date Approved |
|
Macleods |
Famciclovir, 125 mg, 250 mg and 500 mg, tabs. |
201-022 |
1/12/2012 |
|
Invagen |
Alfuzosin HCl, 10 mg extended release, tabs. |
90-284 |
1/17/2012 |
|
Tentative Approvals |
|||
|
Sun Pharma Global |
Eszopiclone, 1 mg, 2 mg and 3 mg tabs. |
91-103 |
1/12/2012 |
|
Amneal |
Escitalopram oxalate, 5 mg/ml solution |
202-227 |
1/18/2012 |