CDER Drug Safety Labeling Changes - 1/19/2021

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 DOCETAXEL DOCETAXEL 201525 NDA 01/13/2021 01/15/2021 NITHIODOTE SODIUM NITRITE; SODIUM THIOSULFATE 201444 NDA 01/13/2021 01/15/2021 SODIUM NITRITE SODIUM NITRITE 203922 NDA 01/13/2021 01/15/2021 XALKORI CRIZOTINIB 202570 NDA 01/14/2021 01/15/2021 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