FDA AVELOX NDA 021085 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for AVELOX, NDA 021085. The package contains 67 FDA documents totaling 1,211 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
• 1 FDA review document
• 34 approval letters
• 32 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 021085
Product: AVELOX
Sponsor: BAYER HLTHCARE
Documents: 67
Pages: 1,211
Coverage: Original approval + 33 supplemental submissions represented