Home Applications 125514 Application 125514
Type BLA
Sponsor MERCK SHARP DOHME Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125514 Keytruda pembrolizumab 351(a) Disc 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KEYTRUDA PEMBROLIZUMAB POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 50MG Yes No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 47 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme LLC BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme LLC BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme LLC BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme LLC BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme LLC BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3026 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3029 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3029 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3029 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3029 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3029 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3029 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3029 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current 0006-3029 KEYTRUDA pembrolizumab Merck Sharp & Dohme Corp. BLA Current