Product Details for: Humate-P
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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)
Humate-P
Rx
002
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Humate-P
Rx
003
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Humate-P
Rx
Proper Name
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Antihemophilic Factor/von Willebrand Factor Complex (Human)
BLA Number
103960
103960
Applicant
CSL Behring GmbH
CSL Behring GmbH
Original Approval Date
April 11, 2000
April 11, 2000
Date of First Licensure