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Andexxa

Coagulation Factor Xa (Recombinant), Inactivated-zhzo

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Andexxa

Proper name

Coagulation Factor Xa (Recombinant), Inactivated-zhzo

Licence type

351(a)

BLA number

125586

Applicant

AstraZeneca AB

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MG	Injection	Intravenous	Single-Dose Vial	Disc	May 3, 2018
200MG	Injection	Intravenous	Single-Dose Vial	Disc	December 31, 2018

Source: Purple Book

Kind	Expires
Orphan exclusivity	May 3, 2025

Purple Book	FDA	Licence type, presentations, reference product, exclusivity