FDA.reportPublic FDA data

Application 761171

Type
BLA
Sponsor
Y-MABS THERAPEUTICS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761171Danyelzanaxitamab-gqgk351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DANYELZANAXITAMAB-GQGKSOLUTION;INTRAVENOUS40MG/10MLNoNo

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
DANYELZANAXITAMABBTG International Inc.b0f5ee96-369f-4cb9-a783-3bfa70fe8f902026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761171

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
73042-201DANYELZANaxitamabY-mAbs Therapeutics, Inc.BLACurrent
73042-201DANYELZANaxitamabY-mAbs Therapeutics, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83234SUPPL 2025-08-29
83216SUPPL 2025-08-28
77910SUPPL 2024-03-21
77898SUPPL 2024-03-21
65696ORIG2020-12-22
65359ORIG2020-11-27
65350ORIG2020-11-25