Product Details for: Crysvita

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
10MG/ML
Single-Dose Vial
351(a)
Crysvita
Rx
002
Injection
Subcutaneous
20MG/ML
Single-Dose Vial
351(a)
Crysvita
Rx
003
Injection
Subcutaneous
30MG/ML
Single-Dose Vial
351(a)
Crysvita
Rx
Proper Name
burosumab-twza
BLA Number
761068
Applicant
Kyowa Kirin, Inc.
Original Approval Date
April 17, 2018
Date of First Licensure
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