FDA PROAMATINE NDA 019815 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for PROAMATINE, NDA 019815. The package contains 5 FDA documents totaling 650 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
• 3 supplemental submissions represented
• 1 FDA review document
• 3 approval letters
• 1 labeling document
• 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 019815
Product: PROAMATINE
Sponsor: TAKEDA PHARMS USA
Documents: 5
Pages: 650
Coverage: Original approval + 3 supplemental submissions represented