Product Details for: Evkeeza
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
345MG/2.3ML (150MG/ML)
Single-Dose Vial
351(a)
Evkeeza
Rx
002
Injection
Intravenous
1,200MG/8ML (150MG/ML)
Single-Dose Vial
351(a)
Evkeeza
Rx
Proper Name
evinacumab-dgnb
evinacumab-dgnb
BLA Number
761181
761181
Applicant
Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals, Inc.
Original Approval Date
February 11, 2021
February 11, 2021
Date of First Licensure