FDA KETEK NDA 021144 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for KETEK, NDA 021144. The package contains 20 FDA documents totaling 360 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
• 10 supplemental submissions represented
• 1 FDA review document
• 10 approval letters
• 9 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 021144
Product: KETEK
Sponsor: SANOFI AVENTIS US
Documents: 20
Pages: 360
Coverage: Original approval + 10 supplemental submissions represented