Application 761464

Type
BLA
Sponsor
DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DATROWAYDATOPOTAMAB DERUXTECAN-DLNKINJECTABLE;INJECTION100MGNoNo

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
DATROWAYDATOPOTAMAB DERUXTECANDaiichi Sankyo Inc.2950227c-6230-4ca4-a135-46e44d9424a02026-05-27Warnings, Adverse reactionsName fallback
brand name: DATROWAY

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82761ORIG 2025-07-09
82655ORIG 2025-06-24
82646ORIG 2025-06-24
82645ORIG 2025-06-23