FDA VISUDYNE NDA 021119 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for VISUDYNE, NDA 021119. The package contains 25 FDA documents totaling 161 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
• 13 approval letters
• 12 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 021119
Product: VISUDYNE
Sponsor: BAUSCH LOMB IRELAND
Documents: 25
Pages: 161
Coverage: Original approval + 12 supplemental submissions represented