FDA FOSRENOL NDA 021468 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for FOSRENOL, NDA 021468. The package contains 27 FDA documents totaling 364 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
• 14 supplemental submissions represented
• 2 FDA review documents
• 14 approval letters
• 11 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 021468
Product: FOSRENOL
Sponsor: TAKEDA PHARMS USA
Documents: 27
Pages: 364
Coverage: Original approval + 14 supplemental submissions represented