FDA VIBATIV NDA 022110 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for VIBATIV, NDA 022110. The package contains 19 FDA documents totaling 324 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
• 11 supplemental submissions represented
• 1 FDA review document
• 10 approval letters
• 8 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 022110
Product: VIBATIV
Sponsor: APOTEX
Documents: 19
Pages: 324
Coverage: Original approval + 11 supplemental submissions represented