Application 761359
- Type
- BLA
- Sponsor
- TAKEDA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENTYVIO | VEDOLIZUMAB | INJECTABLE;INTRAVENOUS | 300MG | No | No |
| 002 | ENTYVIO | VEDOLIZUMAB | INJECTABLE;SUBCUTANEOUS | 108MG/0.68ML | 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 |
|---|---|---|---|---|---|---|
| ENTYVIO | VEDOLIZUMAB | Takeda Pharmaceuticals America, Inc. | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 2026-04-29 | Warnings, Adverse reactions | ENTYVIO VEDOLIZUMAB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.