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Hyqvia

Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Hyqvia

Proper name

Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase

Licence type

351(a)

BLA number

125402

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
0.1	Injection	Subcutaneous	Bottle	Rx	September 12, 2014

Source: Purple Book

Kind	Expires
Orphan exclusivity	January 12, 1931

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