Product Details for: Rixubis

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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)
Rixubis
Rx
002
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Rixubis
Rx
003
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Rixubis
Rx
004
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Rixubis
Rx
005
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Rixubis
Rx
Proper Name
Coagulation Factor IX (Recombinant)
BLA Number
125446
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
June 26, 2013
Date of First Licensure
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