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FDA ZYRTEC NDA 020346 Approval Package — Reviews & Approval Records

FDA ZYRTEC NDA 020346 Approval Package — Reviews & Approval Records

$239.00 USD
$239.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for ZYRTEC, NDA 020346. The package contains 8 FDA documents totaling 425 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
  • 3 supplemental submissions represented
  • 3 FDA review documents
  • 3 approval letters
  • 2 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 020346
Product: ZYRTEC
Sponsor: J AND J CONSUMER INC
Documents: 8
Pages: 425
Coverage: Original approval + 3 supplemental submissions represented
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