FDA VERSED NDA 018654 Approval Package — FDA Reviews

This FOIAdocs regulatory document collection brings together FDA approval records for VERSED, NDA 018654. The package contains 2 FDA documents totaling 794 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
• 1 supplemental submission represented
• 2 FDA review 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 018654
Product: VERSED
Sponsor: HLR
Documents: 2
Pages: 794
Coverage: Original approval + 1 supplemental submission represented