FDA PEPCID AC NDA 020325 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for PEPCID AC, NDA 020325. The package contains 18 FDA documents totaling 98 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
• 12 supplemental submissions represented
• 10 approval letters
• 8 labeling documents
• 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 020325
Product: PEPCID AC
Sponsor: KENVUE BRANDS
Documents: 18
Pages: 98
Coverage: Original approval + 12 supplemental submissions represented