Product Details for: Strensiq

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
18MG/0.45ML
Single-Dose Vial
351(a)
Strensiq
Rx
002
Injection
Subcutaneous
28MG/0.7ML
Single-Dose Vial
351(a)
Strensiq
Rx
003
Injection
Subcutaneous
40MG/ML
Single-Dose Vial
351(a)
Strensiq
Rx
004
Injection
Subcutaneous
80MG/0.8ML
Single-Dose Vial
351(a)
Strensiq
Rx
Proper Name
asfotase alfa
BLA Number
125513
Applicant
Alexion Pharmaceuticals, Inc.
Original Approval Date
October 23, 2015
Date of First Licensure
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