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FDA BUMEX NDA 018226 Approval Package — Approval Records & Labeling

FDA BUMEX NDA 018226 Approval Package — Approval Records & Labeling

$89.00 USD
$89.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for BUMEX, NDA 018226. The package contains 3 FDA documents totaling 23 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
  • 2 supplemental submissions represented
  • 1 approval letter
  • 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 018226
Product: BUMEX
Sponsor: VALIDUS PHARMS
Documents: 3
Pages: 23
Coverage: Original approval + 2 supplemental submissions represented
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