Application 761069
- Type
- BLA
- Sponsor
- ASTRAZENECA UK LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMFINZI | DURVALUMAB | INJECTABLE;INJECTION | 50MG/ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4500 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4611 | IMFINZI | Durvalumab | AstraZeneca Pharmaceuticals LP | BLA | Current |