FDA CIPRO NDA 019537 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for CIPRO, NDA 019537. The package contains 2 FDA documents totaling 49 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
• 1 supplemental submission represented
• 1 approval letter
• 1 labeling document
• 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 019537
Product: CIPRO
Sponsor: BAYER HLTHCARE
Documents: 2
Pages: 49
Coverage: Original approval + 1 supplemental submission represented