FDA INVANZ NDA 021337 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for INVANZ, NDA 021337. The package contains 43 FDA documents totaling 782 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
• 23 supplemental submissions represented
• 1 FDA review document
• 23 approval letters
• 19 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 021337
Product: INVANZ
Sponsor: MSD SUB MERCK
Documents: 43
Pages: 782
Coverage: Original approval + 23 supplemental submissions represented