Application 761286
- Type
- BLA
- Sponsor
- UCB INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761286 | Rystiggo | rozanolixizumab-noli | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYSTIGGO | ROZANOLIXIZUMAB-NOLI | INJECTABLE;SUBCUTANEOUS | 280MG/2ML(140MG/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 |
|---|---|---|---|---|---|---|
| RYSTIGGO | ROZANOLIXIZUMAB | UCB, Inc. | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 2026-01-20 | Warnings, Adverse reactions | BLA761286 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.