Home Applications 125409 Application 125409
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125409 Perjeta pertuzumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PERJETA PERTUZUMAB VIAL; SINGLE-USE 420MG/14ML 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-145 PERJETA Pertuzumab Genentech, Inc. BLA Current 50242-145 PERJETA Pertuzumab Genentech, Inc. BLA Current 50242-145 PERJETA Pertuzumab Genentech, Inc. BLA Current 50242-145 PERJETA Pertuzumab Genentech, Inc. BLA Current 50242-145 PERJETA Pertuzumab Genentech, Inc. BLA Current 50242-145 PERJETA Pertuzumab Genentech, Inc. BLA Current 50242-145 PERJETA Pertuzumab Genentech, Inc. BLA Current