Home Applications 125084 Application 125084
Type BLA
Sponsor IMCLONE Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125084 Erbitux cetuximab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ERBITUX CETUXIMAB VIAL; INTRAVENOUS 100mg/VIAL 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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-948 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current 66733-958 ERBITUX cetuximab ImClone LLC BLA Current