FDA ACTOS NDA 021073 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ACTOS, NDA 021073. The package contains 58 FDA documents totaling 1,130 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
• 36 supplemental submissions represented
• 17 FDA review documents
• 22 approval letters
• 19 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 021073
Product: ACTOS
Sponsor: TAKEDA PHARMS USA
Documents: 58
Pages: 1,130
Coverage: Original approval + 36 supplemental submissions represented