Source facts
FDA issued an approval letter for TYLENOL WITH NAPROXEN on 2026-07-24. The source metadata identifies NDA 219962 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
TYLENOL WITH NAPROXEN — FDA Approval Letter (NDA 219962)
Issued to KENVUE BRANDS LLC. Application is approved as submitted.
Issued
July 24, 2026Application
NDA 505b1 • 219962
Product
TYLENOL WITH NAPROXEN
Company
KENVUE BRANDS LLC
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 219962.
- 3Submission: original application.
- 4Sponsor: KENVUE BRANDS LLC.
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Common questions about the TYLENOL WITH NAPROXEN approval letter
Is TYLENOL WITH NAPROXEN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 219962 for TYLENOL WITH NAPROXEN, sponsored by KENVUE BRANDS LLC, on July 24, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 219962?
NDA 219962 is the application under which FDA issued this approval letter for TYLENOL WITH NAPROXEN to KENVUE BRANDS LLC. The letter is dated July 24, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.