On this page

Vpriv

velaglucerase alfa

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Vpriv
Proper name
velaglucerase alfa
Licence type
351(a)
BLA number
022575
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CDER
Presentations
2
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
200UNITS For Injection Intravenous Single-Dose Vial Disc February 26, 2010
400UNITS For Injection Intravenous Single-Dose Vial Rx February 26, 2010

Sources for this page

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