FDA NIZORAL NDA 019927 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for NIZORAL, NDA 019927. The package contains 5 FDA documents totaling 21 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
• 3 supplemental submissions represented
• 2 approval letters
• 3 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 019927
Product: NIZORAL
Sponsor: JANSSEN PHARMS
Documents: 5
Pages: 21
Coverage: Original approval + 3 supplemental submissions represented