Product Details for: Adynovate

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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)
Adynovate
Rx
002
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Adynovate
Rx
003
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Adynovate
Rx
004
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Adynovate
Rx
005
For Injection
Intravenous
1500IU
Single-Dose Vial
351(a)
Adynovate
Rx
006
For Injection
Intravenous
750IU
Single-Dose Vial
351(a)
Adynovate
Rx
007
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Adynovate
Rx
Proper Name
Antihemophilic Factor (Recombinant), PEGylated
BLA Number
125566
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
November 13, 2015
Date of First Licensure
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