Product Details for: Hemofil M
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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)
Hemofil M
Rx
002
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Hemofil M
Rx
003
For Injection
Intravenous
1700IU
Single-Dose Vial
351(a)
Hemofil M
Rx
004
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Hemofil M
Rx
Proper Name
Antihemophilic Factor (Human)
Antihemophilic Factor (Human)
BLA Number
101448
101448
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
March 14, 2001
March 14, 2001
Date of First Licensure