FDA INDOCIN NDA 017814 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for INDOCIN, NDA 017814. The package contains 12 FDA documents totaling 156 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
• 7 supplemental submissions represented
• 6 approval letters
• 6 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 017814
Product: INDOCIN
Sponsor: COSETTE
Documents: 12
Pages: 156
Coverage: Original approval + 7 supplemental submissions represented