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Albuminex

Albumin (Human)-kjda

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Albuminex

Proper name

Albumin (Human)-kjda

Licence type

351(a)

BLA number

125644

Applicant

Bio Products Laboratory Limited

Center

CBER

Presentations

4

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
12.5G/250ML	Solution	Intravenous	Single-Dose Vial	Rx	June 19, 2018
12.5G/50ML	Solution	Intravenous	Single-Dose Vial	Rx	June 19, 2018
25G/100ML	Solution	Intravenous	Single-Dose Vial	Rx	June 19, 2018
25G/500ML	Solution	Intravenous	Single-Dose Vial	Rx	June 19, 2018

Sources for this page

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