FDA MAGNEVIST NDA 019596 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for MAGNEVIST, NDA 019596. The package contains 22 FDA documents totaling 313 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
• 12 supplemental submissions represented
• 1 FDA review document
• 11 approval letters
• 10 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 019596
Product: MAGNEVIST
Sponsor: BAYER HLTHCARE
Documents: 22
Pages: 313
Coverage: Original approval + 12 supplemental submissions represented