CDER Drug Safety Labeling Changes - 5/25/2021

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 ISENTRESS RALTEGRAVIR POTASSIUM 022145 NDA 05/18/2021 05/21/2021 ISENTRESS RALTEGRAVIR POTASSIUM 203045 NDA 05/18/2021 05/21/2021 ISENTRESS RALTEGRAVIR POTASSIUM 205786 NDA 05/18/2021 05/21/2021 BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 018374 NDA 05/21/2021 05/24/2021 BACTRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM 017560 NDA 05/21/2021 05/24/2021 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