Application 761451
- 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 |
|---|
| 761451 | 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 | ANIFROLIMAB-FNIA | VIAL; SINGLE-USE | 300MG/2ML (150MG/ML | No | No |
| 002 | SAPHNELO | ANIFROLIMAB-FNIA | INJECTION | 120MG/0.8ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85774 | ORIG | 2026-04-28 |
| 85772 | ORIG | 2026-04-27 |