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FDA ASTELIN NDA 020114 Approval Package — Reviews & Approval Records

FDA ASTELIN NDA 020114 Approval Package — Reviews & Approval Records

$329.00 USD
$329.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for ASTELIN, NDA 020114. The package contains 9 FDA documents totaling 596 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
  • 6 supplemental submissions represented
  • 1 FDA review document
  • 5 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 020114
Product: ASTELIN
Sponsor: RISING
Documents: 9
Pages: 596
Coverage: Original approval + 6 supplemental submissions represented
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