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Asceniv

Immune Globulin Intravenous, Human-slra

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Asceniv
Proper name
Immune Globulin Intravenous, Human-slra
Licence type
351(a)
BLA number
125590
Applicant
ADMA Biologics, 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
5G/50ML Injection Intravenous Single-Dose Vial Rx April 1, 2019

Sources for this page

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