Product Details for: Atryn
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1750IU
Single-Dose Vial
351(a)
Atryn
Disc
002
For Injection
Intravenous
525IU
Single-Dose Vial
351(a)
Atryn
Disc
Proper Name
Antithrombin (Recombinant)
Antithrombin (Recombinant)
BLA Number
125284
125284
Applicant
rEVO Biologics, Inc.
rEVO Biologics, Inc.
Original Approval Date
February 6, 2009
February 6, 2009
Date of First Licensure