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FDA DURAGESIC-100 NDA 019813 Approval Package — Reviews & Approval Records

FDA DURAGESIC-100 NDA 019813 Approval Package — Reviews & Approval Records

$599.00 USD
$599.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for DURAGESIC-100, NDA 019813. The package contains 45 FDA documents totaling 2,167 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
  • 29 supplemental submissions represented
  • 13 FDA review documents
  • 20 approval letters
  • 12 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 019813
Product: DURAGESIC-100
Sponsor: JANSSEN PHARMS
Documents: 45
Pages: 2,167
Coverage: Original approval + 29 supplemental submissions represented
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