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Soliqua 100/33

insulin glargine and lixisenatide

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Soliqua 100/33
Proper name
insulin glargine and lixisenatide
Licence type
351(a)
BLA number
208673
Applicant
Sanofi-Aventis U.S. LLC
Center
CDER
Presentations
1
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
300UNITS/3ML (100UNITS/ML); 99MCG/3ML (33MCG/ML) Injection Subcutaneous Autoinjector Rx November 21, 2016

Sources for this page

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