FDA ZAROXOLYN NDA 017386 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ZAROXOLYN, NDA 017386. The package contains 8 FDA documents totaling 75 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
• 6 supplemental submissions represented
• 2 FDA review documents
• 3 approval letters
• 3 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 017386
Product: ZAROXOLYN
Sponsor: I3 PHARMS
Documents: 8
Pages: 75
Coverage: Original approval + 6 supplemental submissions represented