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Purple Book
Database of Licensed Biological Products

Product Details for: Erbitux
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Intravenous100MG/50ML (2MG/ML)Single-Dose Vial351(a)ErbituxRx
002Injection Intravenous200MG/100ML (2MG/ML)Single-Dose Vial351(a)ErbituxRx

Proper Name
cetuximab

BLA Number
125084

Applicant
Eli Lilly and Company

Original Approval Date
February 12, 2004

Date of First Licensure