CDER Drug Safety Labeling Changes - 2/28/2021

Drug Safety-related Labeling Changes (SrLC) The SLC database has been updated with the following approved drug safety labeling changes. Drug Name Active Ingredient Application Number Application Type Supplement Date Database Updated ALIQOPA COPANLISIB DIHYDROCHLORIDE 209936 NDA 02/23/2022 02/25/2022 AMBIEN ZOLPIDEM TARTRATE 019908 NDA 02/23/2022 02/25/2022 AMBIEN CR ZOLPIDEM TARTRATE 021774 NDA 02/23/2022 02/25/2022 CABLIVI CAPLACIZUMAB-YHDP 761112 BLA 02/23/2022 02/25/2022 TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE 210821 NDA 02/22/2022 02/25/2022 Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA