Product Details for: Adlyxin
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
150MCG/3ML (50MCG/ML)
Autoinjector
351(a)
Adlyxin
Disc
002
Injection
Subcutaneous
300MCG/3ML (100MCG/ML)
Autoinjector
351(a)
Adlyxin
Disc
Proper Name
lixisenatide
lixisenatide
BLA Number
208471
208471
Applicant
Sanofi-Aventis U.S. LLC
Sanofi-Aventis U.S. LLC
Original Approval Date
July 27, 2016
July 27, 2016
Date of First Licensure