FDA INSPRA NDA 021437 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for INSPRA, NDA 021437. The package contains 20 FDA documents totaling 210 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
• 8 supplemental submissions represented
• 10 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 021437
Product: INSPRA
Sponsor: UPJOHN
Documents: 20
Pages: 210
Coverage: Original approval + 8 supplemental submissions represented