FDA ZEBETA NDA 019982 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ZEBETA, NDA 019982. The package contains 9 FDA documents totaling 90 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
• 8 supplemental submissions represented
• 5 FDA review documents
• 2 approval letters
• 2 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 019982
Product: ZEBETA
Sponsor: TEVA BRANDED PHARM
Documents: 9
Pages: 90
Coverage: Original approval + 8 supplemental submissions represented