CDER Drug Safety Labeling Changes - 5/19/2021

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 COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 018983 NDA 05/14/2021 05/18/2021 COLYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 018983 NDA 05/14/2021 05/18/2021 COLYTE-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 018983 NDA 05/14/2021 05/18/2021 GOLYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 019011 NDA 05/14/2021 05/18/2021 MAXITROL DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 050023 NDA 05/14/2021 05/18/2021 NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 019797 NDA 05/14/2021 05/18/2021 NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 019797 NDA 05/14/2021 05/18/2021 TOBRADEX DEXAMETHASONE; TOBRAMYCIN 050592 NDA 05/14/2021 05/18/2021 TOBREX TOBRAMYCIN 050541 NDA 05/14/2021 05/18/2021 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