FDA.reportPublic FDA data

Application 761263

Type
BLA
Sponsor
GENENTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761263Lunsumiomosunetuzumab-axgb351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUNSUMIOMOSUNETUZUMAB-AXGBINJECTABLE;INJECTION1MG/MLNoNo
002LUNSUMIOMOSUNETUZUMAB-AXGBINJECTABLE;INJECTION30MG/30MLNoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LunsumioMOSUNETUZUMABGenentech, Inc.2ef0cf38-101c-4681-98fe-c05dc9ead4432026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761263
ndc (product): 50242-159
ndc (product): 50242-142
Lunsumio VeloMOSUNETUZUMABGenentech, Inc.6a2b6dc2-48bd-4da7-a611-bc6bae2893c82026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761263

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-142LunsumioMosunetuzumabGenentech, Inc.BLACurrent
50242-159LunsumioMosunetuzumabGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84693SUPPL 2026-01-06
84692SUPPL 2026-01-06
84520SUPPL 2025-12-23
80431SUPPL 2024-11-26
80333SUPPL 2024-11-25
73446ORIG 2023-02-09
73026ORIG2022-12-23
73018ORIG2022-12-23
73017ORIG2022-12-23