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FDA LEVO-T NDA 021342 Approval Package — Reviews & Approval Records

FDA LEVO-T NDA 021342 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 LEVO-T, NDA 021342. The package contains 18 FDA documents totaling 317 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
  • 8 supplemental submissions represented
  • 2 FDA review documents
  • 9 approval letters
  • 7 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 021342
Product: LEVO-T
Sponsor: CEDIPROF INC
Documents: 18
Pages: 317
Coverage: Original approval + 8 supplemental submissions represented
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