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FDA TENEX NDA 019032 Approval Package — Reviews & Approval Records

FDA TENEX NDA 019032 Approval Package — Reviews & Approval Records

$229.00 USD
$229.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for TENEX, NDA 019032. The package contains 4 FDA documents totaling 327 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
  • 2 supplemental submissions represented
  • 1 FDA review document
  • 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 019032
Product: TENEX
Sponsor: PROMIUS PHARMA
Documents: 4
Pages: 327
Coverage: Original approval + 2 supplemental submissions represented
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