CDER Drug Safety Labeling Changes - 1/4/2021

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 ASTAGRAF XL TACROLIMUS 204096 NDA 12/30/2020 01/01/2021 GONAL-F FOLLITROPIN ALFA/BETA 020378 BLA 12/31/2020 01/03/2021 PROGRAF TACROLIMUS 050708 NDA 12/30/2020 01/01/2021 PROGRAF TACROLIMUS 050709 NDA 12/30/2020 01/03/2021 PROGRAF TACROLIMUS 210115 NDA 12/30/2020 01/03/2021 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