Product Details for: Idelvion

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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)
Idelvion
Rx
002
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Idelvion
Rx
003
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Idelvion
Rx
004
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Idelvion
Rx
005
For Injection
Intravenous
3500IU
Single-Dose Vial
351(a)
Idelvion
Rx
Proper Name
Coagulation Factor IX (Recombinant), Albumin Fusion Protein
BLA Number
125582
Applicant
CSL Behring Lengnau AG
Original Approval Date
March 4, 2016
Date of First Licensure
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