FDA SUBUTEX NDA 020732 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for SUBUTEX, NDA 020732. The package contains 30 FDA documents totaling 506 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
• 18 supplemental submissions represented
• 19 approval letters
• 11 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 020732
Product: SUBUTEX
Sponsor: INDIVIOR
Documents: 30
Pages: 506
Coverage: Original approval + 18 supplemental submissions represented