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Cuvitru

Immune Globulin Subcutaneous (Human), 20% Solution

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Cuvitru
Proper name
Immune Globulin Subcutaneous (Human), 20% Solution
Licence type
351(a)
BLA number
125596
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
Presentations
5
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
10G/50ML Injection Subcutaneous Single-Dose Vial Rx February 7, 2019
1G/5ML Injection Subcutaneous Single-Dose Vial Rx September 13, 2016
2G/10ML Injection Subcutaneous Single-Dose Vial Rx September 13, 2016
4G/20ML Injection Subcutaneous Single-Dose Vial Rx September 13, 2016
8G/40ML Injection Subcutaneous Single-Dose Vial Rx September 13, 2016

Sources for this page

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