FDA Drug Approval Package, Keytruda (pembrolizumab), BLA 125514 — Original Approval & Supplements

This FOIAdocs regulatory document collection brings together FDA approval records for Keytruda (pembrolizumab), BLA 125514, sponsored by Merck Sharp & Dohme. The package contains 233 FDA documents totaling 16,491 pages, organized by original application and supplemental submission.

Instead of locating and downloading individual records across the application history, buyers receive a research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

What's included

• Original FDA approval records
• 104 supplemental submissions represented
• 33 FDA review documents
• 99 approval letters
• 101 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: BLA 125514
Product: Keytruda (pembrolizumab)
Sponsor: Merck Sharp & Dohme
Documents: 233
Pages: 16,491
Coverage: Original approval + 104 supplemental submissions represented