FDA BEXTRA NDA 021341 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for BEXTRA, NDA 021341. The package contains 7 FDA documents totaling 68 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
• 3 supplemental submissions represented
• 4 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 021341
Product: BEXTRA
Sponsor: GD SEARLE
Documents: 7
Pages: 68
Coverage: Original approval + 3 supplemental submissions represented