Request that the FDA grant public disclosure of the clinical pharmacology / bioavailability data supporting the approval of Tylenol with Naproxen (acetaminophen 325 mg / naproxen sodium 110 mg fixed-dose combination tablets), approved July 24, 2026, Kenvue Brands LLC | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-8331

Request that the FDA grant public disclosure of the clinical pharmacology / bioavailability data supporting the approval of Tylenol with Naproxen (acetaminophen 325 mg / naproxen sodium 110 mg fixed-dose combination tablets), approved July 24, 2026, Kenvue Brands LLC

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensJul 30, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgment Letter from FDA DMB to Faik Cankat Tulunay	Jul 30, 2026	--

Keywords

CDER

Citizen Petition

public disclosure of the clinical pharmacology

bioavailability data supporting the approval of

Tylenol with Naproxen (acetaminophen 325 mg

naproxen sodium 110 mg fixed-dose

combination tablets),

approved July 24, 2026, Kenvue Brands LLC

Data from Regulations.gov