CDER Drug Safety Labeling Changes - 2/11/2021

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
ADVIL	IBUPROFEN SODIUM	201803	NDA	02/08/2022	02/10/2022
ALEVE PM	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	205352	NDA	02/08/2022	02/10/2022

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