Application 761123
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761123 | Saphnelo | anifrolumab-fnia | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SAPHNELO | ANIFROLUMAB-FNIA | INJECTABLE;INJECTION | 300MG/2ML(150MG/ML) | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 4 matching rows.
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79353 | SUPPL | 2024-08-09 |
| 79339 | SUPPL | 2024-08-08 |
| 76728 | SUPPL | 2023-12-05 |
| 76722 | SUPPL | 2023-12-04 |
| 68390 | ORIG | 2021-08-17 |
| 68261 | ORIG | 2021-08-02 |
| 68232 | ORIG | 2021-08-02 |