FDA RETROVIR NDA 019655 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for RETROVIR, NDA 019655. The package contains 36 FDA documents totaling 510 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
• 19 supplemental submissions represented
• 18 approval letters
• 18 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 019655
Product: RETROVIR
Sponsor: VIIV HLTHCARE
Documents: 36
Pages: 510
Coverage: Original approval + 19 supplemental submissions represented