FDA ZONALON NDA 020126 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ZONALON, NDA 020126. The package contains 5 FDA documents totaling 45 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
• 4 supplemental submissions represented
• 3 FDA review documents
• 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 020126
Product: ZONALON
Sponsor: MYLAN
Documents: 5
Pages: 45
Coverage: Original approval + 4 supplemental submissions represented