FDA SUDAFED 24 HOUR NDA 020021 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for SUDAFED 24 HOUR, NDA 020021. The package contains 7 FDA documents totaling 94 pages, organized by original application and supplemental submission.

Research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

What's included

• Original FDA approval records
• 6 supplemental submissions represented
• 5 FDA review documents
• 1 approval letter
• 1 labeling document
• FOIAdocs document index and detailed manifest

Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

Application: NDA 020021
Product: SUDAFED 24 HOUR
Sponsor: KENVUE BRANDS
Documents: 7
Pages: 94
Coverage: Original approval + 6 supplemental submissions represented