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Sevenfact

coagulation factor VIIa (recombinant)-jncw

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Sevenfact

Proper name

coagulation factor VIIa (recombinant)-jncw

Licence type

351(a)

BLA number

125641

Applicant

Laboratoire Francais du Fractionnement et des Biotechnologies S.A.

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
1MG	Injection	Intravenous	Single-Dose Vial	Rx	April 1, 2020
2MG	Injection	Intravenous	Single-Dose Vial	Disc	June 20, 2024
5MG	Injection	Intravenous	Single-Dose Vial	Rx	April 1, 2020

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