Product Details for: Jivi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Jivi
Rx
002
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Jivi
Rx
003
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Jivi
Rx
004
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Jivi
Rx
005
For Injection
Intravenous
4000IU
Single-Dose Vial
351(a)
Jivi
Rx
Proper Name
Antihemophilic factor (recombinant), PEGylated-aucl
BLA Number
125661
Applicant
Bayer HealthCare LLC
Original Approval Date
August 29, 2018
Date of First Licensure
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