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Erbitux

cetuximab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Erbitux

Proper name

cetuximab

Licence type

351(a)

BLA number

125084

Applicant

ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MG/50ML (2MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	February 12, 2004
200MG/100ML (2MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	March 28, 2007

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 1, 2013

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity