Erbitux Purple Book BLA 125084

BLA number: 125084
Proprietary names: Erbitux
Proper names: cetuximab
Applicant: ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company
Center: CDER
First observed release: 2020-05-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Erbitux	cetuximab	351(a)	100MG/50ML (2MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2004-02-12
002	Erbitux	cetuximab	351(a)	200MG/100ML (2MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2007-03-28

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
66733-948	ERBITUX	cetuximab	ImClone LLC	current
66733-958	ERBITUX	cetuximab	ImClone LLC	current

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2026-04-01	U	001	Erbitux	351(a)	Rx	ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company
2026-04-01	U	002	Erbitux	351(a)	Rx	ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company
2020-08-01	U	001	Erbitux	351(a)	Rx	Eli Lilly and Company
2020-08-01	U	002	Erbitux	351(a)	Rx	Eli Lilly and Company
2020-05-01	R	001	Erbitux	351(a)	Rx	Eli Lilly and Company
2020-05-01	R	002	Erbitux	351(a)	Rx	Eli Lilly and Company

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2020-05-01	001	Erbitux	351(a)	Rx	Licensed	2004-02-12
2020-05-01	002	Erbitux	351(a)	Rx	Licensed	2007-03-28