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 2026-08-01
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# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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