FDA KERLEDEX NDA 019807 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for KERLEDEX, NDA 019807. The package contains 4 FDA documents totaling 41 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
• 2 supplemental submissions represented
• 2 approval letters
• 2 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 019807
Product: KERLEDEX
Sponsor: SANOFI AVENTIS US
Documents: 4
Pages: 41
Coverage: Original approval + 2 supplemental submissions represented