Home Applications 761394 Application 761394
Type BLA
Sponsor DAIICHI SANKYO INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761394 Datroway datopotamab deruxtecan-dlnk 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DATROWAY DATOPOTAMAB DERUXTECAN-DLNK INJECTABLE; IV (INFUSION) 100MG No No
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DATROWAY DATOPOTAMAB DERUXTECAN Daiichi Sankyo Inc. 2950227c-6230-4ca4-a135-46e44d9424a0 2026-05-27 Warnings, Adverse reactions Exact identifier application number: BLA761394
Documents# Document, Submission type, Date table Document Submission type Date 81269 ORIG 2025-02-18 80914 ORIG 2025-02-04 80877 ORIG 2025-01-17 80876 ORIG 2025-01-17