Application 761270
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMJUDO | TREMELIMUMAB-ACTL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 25MG/1.25ML(20MG/ML) | No | No |
| 002 | IMJUDO | TREMELIMUMAB-ACTL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 300MG/15ML(20MG/ML) | No | No |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| IMJUDO | TREMELIMUMAB | AstraZeneca Pharmaceuticals LP | 6690679c-be2f-4588-a2e4-89fff74dd6be | 2024-07-24 | Warnings, Adverse reactions | IMJUDO |