FDA SABRIL NDA 020427 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for SABRIL, NDA 020427. The package contains 32 FDA documents totaling 568 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
• 19 supplemental submissions represented
• 20 approval letters
• 12 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 020427
Product: SABRIL
Sponsor: LUNDBECK PHARMS LLC
Documents: 32
Pages: 568
Coverage: Original approval + 19 supplemental submissions represented