FDA PLENDIL NDA 019834 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for PLENDIL, NDA 019834. The package contains 20 FDA documents totaling 247 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
• 14 supplemental submissions represented
• 12 FDA review documents
• 4 approval letters
• 4 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 019834
Product: PLENDIL
Sponsor: ASTRAZENECA
Documents: 20
Pages: 247
Coverage: Original approval + 14 supplemental submissions represented