FDA.reportPublic FDA data

Application 125327

Type
BLA
Sponsor
BTG INTERNATIONAL INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125327Voraxazeglucarpidase351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VORAXAZEGLUCARPIDASEINJECTABLE; INJECTION1000 UNITS PER VIALNoNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VoraxazeGLUCARPIDASEBTG International Inc.acaef5a6-b740-40e3-8ffe-74a75c74745c2024-11-27Warnings, Adverse reactionsExact identifier
application number: BLA125327
ndc (product): 50633-210

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50633-210VoraxazeglucarpidaseBTG International Inc.BLACurrent
50633-210VoraxazeglucarpidaseBTG International Inc.BLACurrent
50633-210VoraxazeglucarpidaseBTG International Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59722SUPPL2019-08-15
59695SUPPL2019-08-14
31936SUPPL2013-04-01
18875SUPPL2013-04-01
22802ORIG2012-03-07
31935ORIG2012-01-20
39932ORIG2012-01-17