Product Details for: Bioclate (Armour), Recombinate

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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)
Bioclate (Armour), Recombinate
Rx
002
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Bioclate (Armour), Recombinate
Rx
003
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Bioclate (Armour), Recombinate
Rx
004
For Injection
Intravenous
1500IU
Single-Dose Vial
351(a)
Bioclate (Armour), Recombinate
Rx
005
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Bioclate (Armour), Recombinate
Rx
Proper Name
Antihemophilic Factor (Recombinant)
BLA Number
103375
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
December 10, 1992
Date of First Licensure
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