Home Applications 022575 Application 022575
Type BLA
Sponsor SHIRE HUMAN GENETIC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 022575 VPRIV velaglucerase alfa 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VPRIV VELAGLUCERASE ALFA INJECTABLE;INTRAVENOUS 400 UNITS/VIAL No No 002 VPRIV VELAGLUCERASE ALFA POWDER;INTRAVENOUS 200 UNITS/VIAL No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VPRIV VELAGLUCERASE ALFA Takeda Pharmaceuticals America, Inc. ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf 2024-11-26 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA022575 ndc (product): 54092-701
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54092-701 VPRIV velaglucerase alfa Shire US Manufacturing Inc. BLA Current 54092-701 VPRIV velaglucerase alfa Takeda Pharmaceuticals America, Inc. BLA Current 54092-701 VPRIV velaglucerase alfa Takeda Pharmaceuticals America, Inc. BLA Current 54092-701 VPRIV velaglucerase alfa Shire US Manufacturing Inc. NDA Current 54092-701 VPRIV velaglucerase alfa Shire US Manufacturing Inc. NDA Current 54092-701 VPRIV velaglucerase alfa Takeda Pharmaceuticals America, Inc. BLA Current 54092-701 VPRIV velaglucerase alfa Takeda Pharmaceuticals America, Inc. BLA Current 54092-701 VPRIV velaglucerase alfa Shire US Manufacturing Inc. NDA Current 54092-701 VPRIV velaglucerase alfa Takeda Pharmaceuticals America, Inc. BLA Current