FDA.reportPublic FDA data

Application 761344

Type
BLA
Sponsor
AMGEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761344Imdelltratarlatamab-dlle351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMDELLTRATARLATAMAB-DLLEINJECTABLE;INJECTION1MGNoNo
002IMDELLTRATARLATAMAB-DLLEINJECTABLE;INJECTION10MGNoNo

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IMDELLTRA (AMG757)TARLATAMAB-DLLEAmgen, Inc1e7b6163-5d83-42ea-82c9-cf7620cdc7822026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761344

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84250SUPPL 2025-11-21
84238SUPPL 2025-11-20
84237SUPPL 2025-11-20
78915ORIG 2024-06-27
78506ORIG 2024-05-20
78485ORIG 2024-05-16