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Rixubis

Coagulation Factor IX (Recombinant)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Rixubis

Proper name

Coagulation Factor IX (Recombinant)

Licence type

351(a)

BLA number

125446

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

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
1000IU	For Injection	Intravenous	Single-Dose Vial	Rx	June 26, 2013
2000IU	For Injection	Intravenous	Single-Dose Vial	Rx	June 26, 2013
250IU	For Injection	Intravenous	Single-Dose Vial	Rx	June 26, 2013
3000IU	For Injection	Intravenous	Single-Dose Vial	Rx	June 26, 2013
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	June 26, 2013

Source: Purple Book

Kind	Expires
Orphan exclusivity	September 12, 2021

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