FDA ERAXIS NDA 021632 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for ERAXIS, NDA 021632. The package contains 23 FDA documents totaling 274 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
• 12 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 021632
Product: ERAXIS
Sponsor: VICURON HOLDINGS
Documents: 23
Pages: 274
Coverage: Original approval + 11 supplemental submissions represented