CDER Drug Safety Labeling Changes - 5/18/2021

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 AGGRENOX ASPIRIN; DIPYRIDAMOLE 020884 NDA 05/13/2021 05/17/2021 BOSULIF BOSUTINIB MONOHYDRATE 203341 NDA 05/14/2021 05/17/2021 MAXIDEX DEXAMETHASONE 013422 NDA 05/14/2021 05/17/2021 TOBREX TOBRAMYCIN 050555 NDA 05/14/2021 05/17/2021 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