FDA Drug Approval Package, Wegovy (semaglutide), NDA 215256 — Original Approval & Supplements
FDA Drug Approval Package, Wegovy (semaglutide), NDA 215256 — Original Approval & Supplements
This FOIAdocs regulatory document collection brings together FDA approval records for Wegovy (semaglutide), NDA 215256, sponsored by Novo Nordisk. The package contains 40 FDA documents totaling 2,222 pages, organized by original application and supplemental submission.
Instead of locating and downloading individual records across the application history, buyers receive a research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.
What's included
- Original FDA approval records
- 15 supplemental submissions represented
- 11 FDA review documents
- 13 approval letters
- 16 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 215256
Product: Wegovy (semaglutide)
Sponsor: Novo Nordisk
Documents: 40
Pages: 2,222
Coverage: Original approval + 15 supplemental submissions represented
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