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Gammagard Liquid

Immune Globulin Infusion (Human)

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Gammagard Liquid
Proper name
Immune Globulin Infusion (Human)
Licence type
351(a)
BLA number
125105
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
Presentations
1
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
10% MG/ML Injection Intravenous, Subcutaneous Single-Use Bottle Rx April 27, 2005

Exclusivity

Source: Purple Book
Kind Expires
Orphan exclusivityJune 22, 2019

Sources for this page

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