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Xembify

immune globulin subcutaneous, human-klhw

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Xembify
Proper name
immune globulin subcutaneous, human-klhw
Licence type
351(a)
BLA number
125683
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
4
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
10GM MG/ML Injection Subcutaneous Single-Dose Vial Rx July 3, 2019
1GM MG/ML Injection Subcutaneous Single-Dose Vial Rx July 3, 2019
2GM MG/ML Injection Subcutaneous Single-Dose Vial Rx July 3, 2019
4GM MG/ML Injection Subcutaneous Single-Dose Vial Rx July 3, 2019

Sources for this page

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