Product Details for: Benefix

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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/ML
Single-Dose Vial
351(a)
Benefix
Rx
002
For Injection
Intravenous
500IU/ML
Single-Dose Vial
351(a)
Benefix
Rx
003
For Injection
Intravenous
250IU/ML
Single-Dose Vial
351(a)
Benefix
Rx
004
For Injection
Intravenous
2000IU/ML
Single-Dose Vial
351(a)
Benefix
Rx
005
For Injection
Intravenous
3000IU/ML
Single-Dose Vial
351(a)
Benefix
Rx
Proper Name
Coagulation Factor IX (Recombinant)
BLA Number
103677
Applicant
Wyeth Pharmaceuticals LLC
Original Approval Date
February 11, 1997
Date of First Licensure
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