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FDA IMAGENT NDA 021191 Approval Package — Approval Records & Labeling

FDA IMAGENT NDA 021191 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 IMAGENT, NDA 021191. The package contains 3 FDA documents totaling 26 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
  • 1 supplemental submission represented
  • 2 approval letters
  • 1 labeling document
  • 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 021191
Product: IMAGENT
Sponsor: VESSELON SPV LLC
Documents: 3
Pages: 26
Coverage: Original approval + 1 supplemental submission represented
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