FDA ZOLOFT NDA 020990 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for ZOLOFT, NDA 020990. The package contains 52 FDA documents totaling 1,017 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
• 28 supplemental submissions represented
• 28 approval letters
• 24 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 020990
Product: ZOLOFT
Sponsor: VIATRIS
Documents: 52
Pages: 1,017
Coverage: Original approval + 28 supplemental submissions represented