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FDA BUMEX NDA 018225 Approval Package — Approval Records & Labeling

FDA BUMEX NDA 018225 Approval Package — Approval Records & Labeling

$119.00 USD
$119.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for BUMEX, NDA 018225. The package contains 11 FDA documents totaling 73 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
  • 5 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 018225
Product: BUMEX
Sponsor: VALIDUS PHARMS
Documents: 11
Pages: 73
Coverage: Original approval + 6 supplemental submissions represented
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