Home Applications 103792 Application 103792
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103792 Herceptin trastuzumab 351(a) Disc* 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HERCEPTIN TRASTUZUMAB VIAL; INTRAVENOUS 21MG/ML 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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-132 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-132 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-132 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-132 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-132 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-132 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-134 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-134 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-134 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-134 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-134 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-333 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-333 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-333 Herceptin Trastuzumab Genentech, Inc. BLA Current 50242-333 Herceptin Trastuzumab Genentech, Inc. BLA Current