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)Rx2026-06-01

Application Products#

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

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
DANYELZANAXITAMABBTG International Inc.b0f5ee96-369f-4cb9-a783-3bfa70fe8f902026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761171

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