FDA VIMPAT NDA 022253 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for VIMPAT, NDA 022253. The package contains 47 FDA documents totaling 836 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
• 23 supplemental submissions represented
• 1 FDA review document
• 23 approval letters
• 23 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 022253
Product: VIMPAT
Sponsor: UCB INC
Documents: 47
Pages: 836
Coverage: Original approval + 23 supplemental submissions represented