FDA ZANTAC NDA 019675 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ZANTAC, NDA 019675. The package contains 11 FDA documents totaling 94 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
• 7 supplemental submissions represented
• 1 FDA review document
• 7 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 019675
Product: ZANTAC
Sponsor: GLAXO GRP LTD
Documents: 11
Pages: 94
Coverage: Original approval + 7 supplemental submissions represented