CDER Drug Safety Labeling Changes - 4/29/2021

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 EPCLUSA SOFOSBUVIR; VELPATASVIR 208341 NDA 04/27/2022 04/29/2022 EPCLUSA SOFOSBUVIR; VELPATASVIR 214187 NDA 04/27/2022 04/29/2022 EPIDUO FORTE ADAPALENE; BENZOYL PEROXIDE 207917 NDA 04/27/2022 04/29/2022 IDAMYCIN PFS IDARUBICIN HYDROCHLORIDE 050734 NDA 04/27/2022 04/29/2022 FENSOLVI KIT LEUPROLIDE ACETATE 213150 NDA 04/26/2022 04/29/2022 TRIPTODUR KIT TRIPTORELIN PAMOATE 208956 NDA 04/26/2022 04/29/2022 VEKLURY REMDESIVIR 214787 NDA 04/25/2022 04/28/2022 LUPRON DEPOT-PED KIT LEUPROLIDE ACETATE 020263 NDA 04/22/2022 04/29/2022 METADATE CD METHYLPHENIDATE HYDROCHLORIDE 021259 NDA 04/22/2022 04/29/2022 SUPPRELIN LA HISTRELIN ACETATE 022058 NDA 04/22/2022 04/29/2022 SYNAREL NAFARELIN ACETATE 019886 NDA 04/22/2022 04/29/2022 ZERBAXA CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM 206829 NDA 04/21/2022 04/29/2022 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