FDA NAROPIN NDA 020533 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for NAROPIN, NDA 020533. The package contains 17 FDA documents totaling 673 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
• 10 supplemental submissions represented
• 1 FDA review document
• 8 approval letters
• 8 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 020533
Product: NAROPIN
Sponsor: FRESENIUS KABI USA
Documents: 17
Pages: 673
Coverage: Original approval + 10 supplemental submissions represented