Home Applications 761139 Application 761139
Type BLA
Sponsor DAIICHI SANKYO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761139 Enhertu fam-trastuzumab deruxtecan-nxki 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENHERTU FAM-TRASTUZUMAB DERUXTECAN-NXKI INJECTABLE;INJECTION 100MG 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Enhertu FAM-TRASTUZUMAB DERUXTECAN-NXKI Daiichi Sankyo Inc. 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 2026-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761139 ndc (product): 65597-406
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo, Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo, Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo, Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo, Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo, Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo, Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo, Inc. BLA Current 65597-406 Enhertu fam-trastuzumab deruxtecan-nxki Daiichi Sankyo Inc. BLA Current