FDA OMNIPAQUE 12 NDA 018956 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for OMNIPAQUE 12, NDA 018956. The package contains 25 FDA documents totaling 411 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
• 16 supplemental submissions represented
• 1 FDA review document
• 15 approval letters
• 9 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 018956
Product: OMNIPAQUE 12
Sponsor: GE HEALTHCARE
Documents: 25
Pages: 411
Coverage: Original approval + 16 supplemental submissions represented