Product Details for: Fibryga
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1G
Single-Use Bottle
351(a)
Fibryga
Rx
002
For Injection
Intravenous
2G
Single-Use Bottle
351(a)
Fibryga
Rx
Proper Name
Fibrinogen (Human)
Fibrinogen (Human)
BLA Number
125612
125612
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Original Approval Date
June 7, 2017
June 7, 2017
Date of First Licensure