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Balfaxar

Prothrombin complex concentrate, human-lans

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Balfaxar

Proper name

Prothrombin complex concentrate, human-lans

Licence type

351(a)

BLA number

125776

Applicant

Octapharma Pharmazeutika Produktionsges.m.b.H.

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	July 21, 2023
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	July 21, 2023

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