FDA INDOCIN NDA 016059 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for INDOCIN, NDA 016059. The package contains 12 FDA documents totaling 157 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 016059
Product: INDOCIN
Sponsor: ZYLA LIFE SCIENCES
Documents: 12
Pages: 157
Coverage: Original approval + 7 supplemental submissions represented