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FDA GEMZAR NDA 020509 Approval Package — Reviews & Approval Records

FDA GEMZAR NDA 020509 Approval Package — Reviews & Approval Records

$459.00 USD
$459.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for GEMZAR, NDA 020509. The package contains 31 FDA documents totaling 1,083 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
  • 17 supplemental submissions represented
  • 3 FDA review documents
  • 14 approval letters
  • 14 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 020509
Product: GEMZAR
Sponsor: LILLY
Documents: 31
Pages: 1,083
Coverage: Original approval + 17 supplemental submissions represented
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