FDA PRIMACOR NDA 019436 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for PRIMACOR, NDA 019436. The package contains 4 FDA documents totaling 19 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
• 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 019436
Product: PRIMACOR
Sponsor: SANOFI AVENTIS US
Documents: 4
Pages: 19
Coverage: Original approval + 3 supplemental submissions represented