Product Details for: Rebinyn

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Rebinyn
Rx
002
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Rebinyn
Rx
003
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Rebinyn
Rx
004
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Rebinyn
Rx
Proper Name
Coagulation Factor IX (Recombinant), GlycoPEGylated
BLA Number
125611
Applicant
Novo Nordisk Inc.
Original Approval Date
May 31, 2017
Date of First Licensure
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