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)Rx2026-08-01

Application Products#

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

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
KIMMTRAKTEBENTAFUSPImmunocore Commercial LLC24a49f57-d2fc-4ffe-9eb1-fe0460c6b0672026-08-20Boxed 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