FDA CARDENE NDA 019734 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CARDENE, NDA 019734. The package contains 21 FDA documents totaling 315 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
• 11 supplemental submissions represented
• 2 FDA review documents
• 11 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 019734
Product: CARDENE
Sponsor: CHIESI
Documents: 21
Pages: 315
Coverage: Original approval + 11 supplemental submissions represented