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Purple Book
Database of Licensed Biological Products

Product Details for: Toujeo
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 Subcutaneous450UNITS/1.5ML (300UNITS/ML)Autoinjector351(a)ToujeoRx
002Injection Subcutaneous900UNITS/3ML (300UNITS/ML)Autoinjector351(a)ToujeoRx

Proper Name
insulin glargine

BLA Number
206538

Applicant
Sanofi-Aventis U.S. LLC

Original Approval Date
February 25, 2015

Date of First Licensure