FDA CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA 019858 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, NDA 019858. The package contains 6 FDA documents totaling 259 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 FDA review documents
• 2 approval letters
• 2 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 019858
Product: CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: BAYER PHARMS
Documents: 6
Pages: 259
Coverage: Original approval + 3 supplemental submissions represented