FDA Drug Approval Package, Zepbound (tirzepatide), NDA 217806 — Original Approval & Supplements
FDA Drug Approval Package, Zepbound (tirzepatide), NDA 217806 — Original Approval & Supplements
This FOIAdocs regulatory document collection brings together FDA approval records for Zepbound (tirzepatide), NDA 217806, sponsored by Eli Lilly and Company. The package contains 29 FDA documents totaling 1,412 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
- 9 supplemental submissions represented
- 10 FDA review documents
- 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 217806
Product: Zepbound (tirzepatide)
Sponsor: Eli Lilly and Company
Documents: 29
Pages: 1,412
Coverage: Original approval + 9 supplemental submissions represented
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