Product Details for: Proplex-T; Bebulin
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
200-1200U/20ML
Vial
351(a)
Proplex-T; Bebulin
Rx
Proper Name
Factor IX Complex
Factor IX Complex
BLA Number
103112
103112
Applicant
Baxalta US Inc.
Baxalta US Inc.
Original Approval Date
August 21, 1970
August 21, 1970
Date of First Licensure