FDA CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER NDA 019857 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, NDA 019857. The package contains 61 FDA documents totaling 1,686 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
• 33 supplemental submissions represented
• 6 FDA review documents
• 27 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 019857
Product: CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: BAYER HLTHCARE
Documents: 61
Pages: 1,686
Coverage: Original approval + 33 supplemental submissions represented