Product Details for: Soliqua 100/33
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML); 99MCG/3ML (33MCG/ML)
Autoinjector
351(a)
Soliqua 100/33
Rx
Proper Name
insulin glargine and lixisenatide
insulin glargine and lixisenatide
BLA Number
208673
208673
Applicant
Sanofi-Aventis U.S. LLC
Sanofi-Aventis U.S. LLC
Original Approval Date
November 21, 2016
November 21, 2016
Date of First Licensure