Application 761123
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Purple Book Biologic Products#
| 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 | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SAPHNELO | ANIFROLUMAB-FNIA | INJECTABLE;INJECTION | 300MG/2ML(150MG/ML) | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SAPHNELO | ANIFROLUMAB-FNIA | AstraZeneca Pharmaceuticals LP | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 2026-04-24 | Warnings, Adverse reactions | BLA761123 0310-3040 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |