Product Details for: Takhzyro

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
300MG/2ML (150MG/ML)
Single-Dose Vial
351(a)
Takhzyro
Disc
002
Injection
Subcutaneous
300MG/2ML (150MG/ML)
Pre-Filled Syringe
351(a)
Takhzyro
Rx
003
Injection
Subcutaneous
150MG/1ML (150MG/ML)
Pre-Filled Syringe
351(a)
Takhzyro
Rx
Proper Name
lanadelumab-flyo
BLA Number
761090
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
August 23, 2018
Date of First Licensure