Product Details for: Kovaltry

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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)
Kovaltry
Rx
002
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Kovaltry
Rx
003
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Kovaltry
Rx
004
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Kovaltry
Rx
005
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Kovaltry
Rx
Proper Name
Antihemophilic Factor (Recombinant), Full Length
BLA Number
125574
Applicant
Bayer HealthCare LLC
Original Approval Date
March 16, 2016
Date of First Licensure
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