Product Details for: Autoplex, Feiba Nf, Feiba Vh
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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
Bottle
351(a)
Autoplex, Feiba Nf, Feiba Vh
Disc
002
For Injection
Intravenous
500IU
Bottle
351(a)
Autoplex, Feiba Nf, Feiba Vh
Disc
003
For Injection
Intravenous
1000U
Single-Dose Vial
351(a)
Autoplex, Feiba Nf, Feiba Vh
Rx
004
For Injection
Intravenous
500U
Bottle
351(a)
Autoplex, Feiba Nf, Feiba Vh
Rx
005
For Injection
Intravenous
2500U
Single-Dose Vial
351(a)
Autoplex, Feiba Nf, Feiba Vh
Rx
Proper Name
Anti-Inhibitor Coagulant Complex
Anti-Inhibitor Coagulant Complex
BLA Number
101447
101447
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
December 21, 1979
December 21, 1979
Date of First Licensure