Application 761331
- Type
- BLA
- Sponsor
- AMGEN INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761331 | Wezlana | ustekinumab-auub | 351(k) Interchangeable | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WEZLANA | USTEKINUMAB-AUUB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 130MG/26ML | 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 |
|---|---|---|---|---|---|---|
| WEZLANA | USTEKINUMAB-AUUB | Nuvaila Limited | a6c23978-09f0-4796-88f7-d0ce7e3ed04e | 2026-06-03 | Warnings, Adverse reactions | BLA761331 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.