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FDA PREMPHASE 14/14 NDA 020527 Approval Package — Reviews & Approval Records

FDA PREMPHASE 14/14 NDA 020527 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 PREMPHASE 14/14, NDA 020527. The package contains 37 FDA documents totaling 1,907 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
  • 21 supplemental submissions represented
  • 6 FDA review documents
  • 16 approval letters
  • 15 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 020527
Product: PREMPHASE 14/14
Sponsor: WYETH PHARMS
Documents: 37
Pages: 1,907
Coverage: Original approval + 21 supplemental submissions represented
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