FDA DEPAKOTE NDA 018723 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for DEPAKOTE, NDA 018723. The package contains 57 FDA documents totaling 2,348 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
• 29 supplemental submissions represented
• 28 approval letters
• 29 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 018723
Product: DEPAKOTE
Sponsor: ABBVIE
Documents: 57
Pages: 2,348
Coverage: Original approval + 29 supplemental submissions represented