FDA VIOXX NDA 021052 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for VIOXX, NDA 021052. The package contains 16 FDA documents totaling 396 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
• 8 supplemental submissions represented
• 3 FDA review documents
• 8 approval letters
• 5 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 021052
Product: VIOXX
Sponsor: MERCK
Documents: 16
Pages: 396
Coverage: Original approval + 8 supplemental submissions represented