Drug Index

ERBITUX

Generic: CETUXIMAB

Review priority: STANDARD Marketing status: Prescription

Route: INTRAVENOUS
Class: General Medications
Safety profile: routine
Latest regulatory update: 24 Sept 2021, 12:00 am (UTC)

Structured Monograph

Approval overview ERBITUX is listed in Drugs@FDA under application 125084 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient CETUXIMAB Form and strength VIAL; INTRAVENOUS - 100mg/VIAL Sponsor IMCLONE Submission history Latest submission status date: 2021-09-24 00:00:00. Submission type: SUPPL.