Product Details for: Ixinity

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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)
Ixinity
Disc
002
For Injection
Intravenous
1500IU
Single-Dose Vial
351(a)
Ixinity
Rx
003
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Ixinity
Rx
004
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Ixinity
Disc
005
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Ixinity
Rx
006
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Ixinity
Disc
Proper Name
Coagulation Factor IX (Recombinant)
BLA Number
125426
Applicant
Medexus Pharma, Inc.
Original Approval Date
April 29, 2015
Date of First Licensure
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