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FDA DESOGEN NDA 020071 Approval Package — Approval Records & Labeling

FDA DESOGEN NDA 020071 Approval Package — Approval Records & Labeling

$169.00 USD
$169.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for DESOGEN, NDA 020071. The package contains 7 FDA documents totaling 153 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
  • 4 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 020071
Product: DESOGEN
Sponsor: ORGANON USA INC
Documents: 7
Pages: 153
Coverage: Original approval + 4 supplemental submissions represented
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