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Alyglo

immune globulin intravenous, human-stwk

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Alyglo
Proper name
immune globulin intravenous, human-stwk
Licence type
351(a)
BLA number
125743
Applicant
GC Biopharma Corp.
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% 100MG/ML Injection Intravenous Single-Dose Vial Rx December 15, 2023

Sources for this page

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