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Buminate, Flexbumin

Albumin (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Buminate, Flexbumin

Proper name

Albumin (Human)

Licence type

351(a)

BLA number

101452

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Center

CBER

Presentations

5

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
10G/50ML	Injection	Intravenous	Bottle	Rx	March 3, 1954
12.5G/250ML	Injection	Intravenous	Bottle	Rx	March 3, 1954
12.5G/50ML	Injection	Intravenous	Bottle	Rx	March 3, 1954
20G/100ML	Injection	Intravenous	Bottle	Rx	March 3, 1954
25G/100ML	Injection	Intravenous	Bottle	Rx	March 3, 1954

Sources for this page

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