FDA LIVALO NDA 022363 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for LIVALO, NDA 022363. The package contains 26 FDA documents totaling 351 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
• 12 supplemental submissions represented
• 1 FDA review document
• 13 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 022363
Product: LIVALO
Sponsor: KOWA CO
Documents: 26
Pages: 351
Coverage: Original approval + 12 supplemental submissions represented