Application 761123
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SAPHNELO | ANIFROLUMAB-FNIA | INJECTABLE;INJECTION | 300MG/2ML(150MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-3040 | SAPHNELO | Anifrolumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-3040 | SAPHNELO | Anifrolumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-3040 | SAPHNELO | Anifrolumab | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-3040 | SAPHNELO | Anifrolumab | AstraZeneca Pharmaceuticals LP | BLA | Current |