FDA XENAZINE NDA 021894 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for XENAZINE, NDA 021894. The package contains 15 FDA documents totaling 230 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
• 8 supplemental submissions represented
• 1 FDA review document
• 9 approval letters
• 5 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 021894
Product: XENAZINE
Sponsor: BAUSCH
Documents: 15
Pages: 230
Coverage: Original approval + 8 supplemental submissions represented