FDA ZANTAC 150 NDA 018703 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for ZANTAC 150, NDA 018703. The package contains 9 FDA documents totaling 75 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
• 6 supplemental submissions represented
• 6 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 018703
Product: ZANTAC 150
Sponsor: GLAXO GRP LTD
Documents: 9
Pages: 75
Coverage: Original approval + 6 supplemental submissions represented