FDA.reportPublic FDA data

Application 761238

Type
BLA
Sponsor
TG THERAPEUTICS, INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761238Briumviublituximab-xiiy351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIUMVIUBLITUXIMABINJECTABLE;INTRAVENOUS25 MG/MLNoNo

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRIUMVIUBLITUXIMABTG Therapeutics, Inc.3a77cd8c-811b-407c-9140-d0c5c26435c22026-02-19Warnings, Adverse reactionsExact identifier
application number: BLA761238
ndc (product): 73150-150

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73150-150BRIUMVIublituximabTG Therapeutics, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84813SUPPL 2026-01-22
84804SUPPL 2026-01-21
83149SUPPL 2025-08-20
83148SUPPL 2025-08-20
83139SUPPL 2025-08-19
83138SUPPL 2025-08-19
80061SUPPL 2024-11-01
80055SUPPL 2024-10-31
73390ORIG 2023-02-06
73061ORIG2022-12-29
73056ORIG2022-12-28