FDA CIPRO NDA 019847 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CIPRO, NDA 019847. The package contains 66 FDA documents totaling 1,740 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
• 35 supplemental submissions represented
• 7 FDA review documents
• 31 approval letters
• 28 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 019847
Product: CIPRO
Sponsor: BAYER HLTHCARE
Documents: 66
Pages: 1,740
Coverage: Original approval + 35 supplemental submissions represented