Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219962
Company: KENVUE BRANDS

Products on NDA 219962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYLENOL WITH NAPROXEN	ACETAMINOPHEN; NAPROXEN SODIUM	325MG;110MG	TABLET;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2026	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219962s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219962Orig1s000ltr.pdf

Labels for NDA 219962

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2026	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219962s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

TYLENOL WITH NAPROXEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 325MG;110MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
TYLENOL WITH NAPROXEN	ACETAMINOPHEN; NAPROXEN SODIUM	325MG;110MG	TABLET;ORAL	Over-the-counter	Yes	219962	KENVUE BRANDS