FDA CHANTIX NDA 021928 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CHANTIX, NDA 021928. The package contains 57 FDA documents totaling 2,441 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
• 29 supplemental submissions represented
• 12 FDA review documents
• 24 approval letters
• 21 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 021928
Product: CHANTIX
Sponsor: PF PRISM CV
Documents: 57
Pages: 2,441
Coverage: Original approval + 29 supplemental submissions represented