FDA Drug Approval Package, Mounjaro (tirzepatide), NDA 215866 — Original Approval & Supplements

This FOIAdocs regulatory document collection brings together FDA approval records for Mounjaro (tirzepatide), NDA 215866, sponsored by Eli Lilly and Company. The package contains 28 FDA documents totaling 1,504 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
• 11 FDA review documents
• 9 approval letters
• 8 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 215866
Product: Mounjaro (tirzepatide)
Sponsor: Eli Lilly and Company
Documents: 28
Pages: 1,504
Coverage: Original approval + 8 supplemental submissions represented