FDA.reportPublic FDA data

Application 761228

Type
BLA
Sponsor
IMMUNOCORE LTD

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761228Kimmtraktebentafusp-tebn351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KIMMTRAKTEBENTAFUSP-TEBNINJECTABLE;INJECTION100MCG/0.5MLNoNo

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
KIMMTRAKTEBENTAFUSPImmunocore Commercial LLC24a49f57-d2fc-4ffe-9eb1-fe0460c6b0672025-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761228
ndc (product): 80446-401

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
80446-401KIMMTRAKTEBENTAFUSPImmunocore Commercial LLCBLACurrent
80446-401KIMMTRAKTEBENTAFUSPImmunocore Commercial LLCBLACurrent
80446-401KIMMTRAKTEBENTAFUSPImmunocore Commercial LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78932SUPPL 2024-06-28
78930SUPPL 2024-06-28
72762SUPPL2022-12-01
72751SUPPL2022-11-30
70238ORIG2022-02-23
69983ORIG2022-01-27
69977ORIG2022-01-26