Application 761289
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMJUDO | TREMELIMUMAB-ACTL | INJECTABLE;INTRAVENOUS | 25MG/1.25ML(20MG/ML) | No | No |
| 002 | IMJUDO | TREMELIMUMAB-ACTL | INJECTABLE;INTRAVENOUS | 300MG/15ML(20MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-4505 | IMJUDO | tremelimumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4505 | IMJUDO | tremelimumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4505 | IMJUDO | tremelimumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4535 | IMJUDO | tremelimumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4535 | IMJUDO | tremelimumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4535 | IMJUDO | tremelimumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79205 | SUPPL | 2024-07-25 |
| 77321 | SUPPL | 2024-01-26 |
| 77307 | SUPPL | 2024-01-26 |
| 74494 | SUPPL | 2023-06-15 |
| 74492 | SUPPL | 2023-06-15 |
| 72565 | ORIG | 2022-11-04 |
| 72524 | SUPPL | 2022-11-01 |
| 72523 | SUPPL | 2022-11-01 |
| 72518 | ORIG | 2022-11-01 |
| 72514 | ORIG | 2022-10-31 |
| 72513 | ORIG | 2022-10-31 |
| 72512 | SUPPL | 2022-10-31 |
| 72455 | ORIG | 2022-10-24 |