Application 761364
- Type
- BLA
- Sponsor
- ACCORD BIOPHARMA INC.
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761364 | Imuldosa | ustekinumab-srlf | 351(k) Interchangeable | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMULDOSA | USTEKINUMAB-SRLF | INJECTABLE;INTRAVENOUS | 45MG/0.5ML | No | No |
| 002 | IMULDOSA | USTEKINUMAB-SRLF | INJECTABLE;INTRAVENOUS | 90MG/ML | No | No |
| 003 | IMULDOSA | USTEKINUMAB-SRLF | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|
| IMULDOSA | USTEKINUMAB-SRLF | Accord BioPharma Inc. | 2539a6cf-0fe5-1565-e063-6294a90a3618 | 2026-06-17 | Warnings, Adverse reactions | BLA761364 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.