FDA VASOTEC NDA 019309 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for VASOTEC, NDA 019309. The package contains 14 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
• 2 approval letters
• 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 019309
Product: VASOTEC
Sponsor: BIOVAIL LABS INTL
Documents: 14
Pages: 247
Coverage: Original approval + 14 supplemental submissions represented