Product Details for: Alphanate
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Alphanate
Rx
002
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Alphanate
Rx
003
For Injection
Intravenous
1500IU
Single-Dose Vial
351(a)
Alphanate
Rx
004
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Alphanate
Rx
005
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Alphanate
Rx
Proper Name
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Antihemophilic Factor/von Willebrand Factor Complex (Human)
BLA Number
102475
102475
Applicant
Grifols Biologicals LLC
Grifols Biologicals LLC
Original Approval Date
August 15, 1978
August 15, 1978
Date of First Licensure