FDA Drug Approval Package, Epidiolex (cannabidiol), NDA 210365 — Original Approval & Supplements

This FOIAdocs regulatory document collection brings together FDA approval records for Epidiolex (cannabidiol), NDA 210365, sponsored by Jazz Pharmaceuticals. The package contains 33 FDA documents totaling 1,514 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
• 10 supplemental submissions represented
• 11 FDA review documents
• 11 approval letters
• 11 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 210365
Product: Epidiolex (cannabidiol)
Sponsor: Jazz Pharmaceuticals
Documents: 33
Pages: 1,514
Coverage: Original approval + 10 supplemental submissions represented