Last Updated: September 28, 2026

Details for New Drug Application (NDA): 219962

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NDA 219962 describes TYLENOL WITH NAPROXEN, which is a drug marketed by Kenvue Brands and is included in one NDA. Additional details are available on the TYLENOL WITH NAPROXEN profile page.

The generic ingredient in TYLENOL WITH NAPROXEN is acetaminophen; naproxen sodium. There is one drug master file entry for this compound. Additional details are available on the acetaminophen; naproxen sodium profile page.

Summary for 219962

Tradename:	TYLENOL WITH NAPROXEN
Applicant:	Kenvue Brands
Ingredient:	acetaminophen; naproxen sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	325MG;110MG
Approval Date:	Jul 24, 2026	TE:		RLD:	Yes

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