CDER Drug Safety Labeling Changes - 2/19/2021

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 ASMANEX TWISTHALER MOMETASONE FUROATE 021067 NDA 02/16/2021 02/18/2021 CEREBYX FOSPHENYTOIN SODIUM 020450 NDA 02/16/2021 02/18/2021 DILANTIN-125 PHENYTOIN 008762 NDA 02/16/2021 02/18/2021 EPZICOM ABACAVIR SULFATE; LAMIVUDINE 021652 NDA 02/17/2021 02/18/2021 TRIZIVIR ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE 021205 NDA 02/17/2021 02/18/2021 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