Product Details for: Andembry

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
200MG/1.2ML (167MG/ML)
Autoinjector
351(a)
Andembry
Rx
002
Injection
Subcutaneous
200MG/1.2ML (167MG/ML)
Pre-Filled Syringe
351(a)
Andembry
Rx
Proper Name
garadacimab-gxii
BLA Number
761367
Applicant
CSL Behring LLC
Original Approval Date
June 16, 2025
Date of First Licensure
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