Product Details for: Alprolix

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Alprolix
Rx
002
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Alprolix
Rx
003
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Alprolix
Rx
004
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Alprolix
Rx
005
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Alprolix
Rx
006
For Injection
Intravenous
4000IU
Single-Dose Vial
351(a)
Alprolix
Rx
Proper Name
Coagulation Factor IX (Recombinant), Fc Fusion Protein
BLA Number
125444
Applicant
Bioverativ Therapeutics, Inc.
Original Approval Date
March 28, 2014
Date of First Licensure
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