1 1

FDA STROMECTOL NDA 050742 Approval Package — Reviews & Approval Records

FDA STROMECTOL NDA 050742 Approval Package — Reviews & Approval Records

$229.00 USD
$229.00 USD
Sale Sold out

This FOIAdocs regulatory document collection brings together FDA approval records for STROMECTOL, NDA 050742. The package contains 20 FDA documents totaling 478 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
  • 11 supplemental submissions represented
  • 1 FDA review document
  • 9 approval letters
  • 10 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 050742
Product: STROMECTOL
Sponsor: MERCK SHARP DOHME
Documents: 20
Pages: 478
Coverage: Original approval + 11 supplemental submissions represented
View full details
FOIA Pro

This drug has a lot more FDA history than one product page can show

FOIA Pro gives you full-text search across 70,000+ FDA FOIA records, from 2020 through today, plus a monthly monitor tracking new requests as they close.
  • Full-text search across every FDA FOIA log since 2020
  • Warning letters, approval records, and correspondence in one place
  • Monthly FDA FOIA Monitor newsletter, included
  • Cancel anytime, monthly or annual billing
Get FOIA Pro
Live search · FOIA database
Searching related FDA records…
ClosedTypeSubjectOutcome