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Toujeo

insulin glargine

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Toujeo
Proper name
insulin glargine
Licence type
351(a)
BLA number
206538
Applicant
Sanofi-Aventis U.S. LLC
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
450UNITS/1.5ML (300UNITS/ML) Injection Subcutaneous Autoinjector Rx February 25, 2015
900UNITS/3ML (300UNITS/ML) Injection Subcutaneous Autoinjector Rx March 26, 2018

Sources for this page

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