FDA VIDEX NDA 020154 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for VIDEX, NDA 020154. The package contains 17 FDA documents totaling 473 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
• 11 supplemental submissions represented
• 3 FDA review documents
• 6 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 020154
Product: VIDEX
Sponsor: BRISTOL MYERS SQUIBB
Documents: 17
Pages: 473
Coverage: Original approval + 11 supplemental submissions represented