FDA SPORANOX NDA 020083 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for SPORANOX, NDA 020083. The package contains 39 FDA documents totaling 812 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
• 20 supplemental submissions represented
• 19 approval letters
• 20 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 020083
Product: SPORANOX
Sponsor: JANSSEN PHARMS
Documents: 39
Pages: 812
Coverage: Original approval + 20 supplemental submissions represented