FDA ZOLADEX NDA 019726 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ZOLADEX, NDA 019726. The package contains 24 FDA documents totaling 307 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
• 15 supplemental submissions represented
• 1 FDA review document
• 14 approval letters
• 9 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 019726
Product: ZOLADEX
Sponsor: TERSERA
Documents: 24
Pages: 307
Coverage: Original approval + 15 supplemental submissions represented