Application 761394
- Type
- BLA
- Sponsor
- DAIICHI SANKYO INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761394 | Datroway | datopotamab deruxtecan-dlnk | 351(a) | Rx | 2026-09-01 |
Application Products#
| 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.
| 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 | BLA761394 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.