FDA Drug Approval Package, Spravato (esketamine), NDA 211243 — Original Approval & Supplements

This FOIAdocs regulatory document collection brings together FDA approval records for Spravato (esketamine), NDA 211243, sponsored by Janssen Pharmaceuticals. The package contains 38 FDA documents totaling 2,098 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
• 17 supplemental submissions represented
• 12 FDA review documents
• 18 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 211243
Product: Spravato (esketamine)
Sponsor: Janssen Pharmaceuticals
Documents: 38
Pages: 2,098
Coverage: Original approval + 17 supplemental submissions represented