FDA ERAXIS NDA 021948 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for ERAXIS, NDA 021948. The package contains 2 FDA documents totaling 26 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 approval letter
• 1 labeling document
• 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 021948
Product: ERAXIS
Sponsor: PFIZER
Documents: 2
Pages: 26
Coverage: Original approval