FDA XYREM NDA 021196 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for XYREM, NDA 021196. The package contains 44 FDA documents totaling 1,455 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
• 27 supplemental submissions represented
• 4 FDA review documents
• 27 approval letters
• 13 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 021196
Product: XYREM
Sponsor: JAZZ PHARMS
Documents: 44
Pages: 1,455
Coverage: Original approval + 27 supplemental submissions represented