Home Applications 125427 Application 125427
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125427 Kadcyla ado-trastuzumab emtansine 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KADCYLA ADO-TRASTUZUMAB EMTANSINE VIAL; SINGLE-USE 100MG No No 002 KADCYLA ADO-TRASTUZUMAB EMTANSINE VIAL; SINGLE-USE 160MG No 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-087 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-087 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-087 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-087 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-087 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-087 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-087 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-088 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-088 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-088 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-088 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-088 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-088 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current 50242-088 KADCYLA ADO-TRASTUZUMAB EMTANSINE Genentech, Inc. BLA Current