Product Details for: Andexxa
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
100MG
Single-Dose Vial
351(a)
Andexxa
Disc
002
Injection
Intravenous
200MG
Single-Dose Vial
351(a)
Andexxa
Disc
Proper Name
Coagulation Factor Xa (Recombinant), Inactivated-zhzo
Coagulation Factor Xa (Recombinant), Inactivated-zhzo
BLA Number
125586
125586
Applicant
AstraZeneca AB
AstraZeneca AB
Original Approval Date
May 3, 2018
May 3, 2018
Date of First Licensure