CDER Drug Safety Labeling Changes - 7/1/2021

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 DIPENTUM OLSALAZINE SODIUM 019715 NDA 06/25/2021 06/28/2021 ROWASA MESALAMINE 019618 NDA 06/25/2021 06/28/2021 ADHANSIA XR METHYLPHENIDATE HYDROCHLORIDE 212038 NDA 06/25/2021 06/29/2021 APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 205831 NDA 06/25/2021 06/29/2021 CAROSPIR SPIRONOLACTONE 209478 NDA 06/25/2021 06/29/2021 CONCERTA METHYLPHENIDATE HYDROCHLORIDE 021121 NDA 06/25/2021 06/29/2021 COTEMPLA XR-ODT METHYLPHENIDATE 205489 NDA 06/25/2021 06/29/2021 DAYTRANA METHYLPHENIDATE 021514 NDA 06/25/2021 06/29/2021 JORNAY PM METHYLPHENIDATE HYDROCHLORIDE 209311 NDA 06/25/2021 06/29/2021 METADATE CD METHYLPHENIDATE HYDROCHLORIDE 021259 NDA 06/25/2021 06/29/2021 METHYLIN METHYLPHENIDATE HYDROCHLORIDE 021419 NDA 06/25/2021 06/29/2021 METHYLIN METHYLPHENIDATE HYDROCHLORIDE 021475 NDA 06/25/2021 06/29/2021 QUILLICHEW ER METHYLPHENIDATE HYDROCHLORIDE 207960 NDA 06/25/2021 06/29/2021 QUILLIVANT XR METHYLPHENIDATE HYDROCHLORIDE 202100 NDA 06/25/2021 06/29/2021 ASTEPRO AZELASTINE HYDROCHLORIDE 022203 NDA 06/28/2021 06/30/2021 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 021278 NDA 06/26/2021 06/30/2021 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 021802 NDA 06/26/2021 06/30/2021 RITALIN METHYLPHENIDATE HYDROCHLORIDE 010187 NDA 06/26/2021 06/30/2021 RITALIN LA METHYLPHENIDATE HYDROCHLORIDE 021284 NDA 06/26/2021 06/30/2021 SYMTUZA COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 210455 NDA 06/28/2021 06/30/2021 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