FDA EVISTA NDA 020815 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for EVISTA, NDA 020815. The package contains 8 FDA documents totaling 103 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
• 5 supplemental submissions represented
• 1 FDA review document
• 4 approval letters
• 3 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 020815
Product: EVISTA
Sponsor: LILLY
Documents: 8
Pages: 103
Coverage: Original approval + 5 supplemental submissions represented