Application 761430
- Type
- BLA
- Sponsor
- JANSSEN BIOTECH
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761430 | Imaavy | nipocalimab-aahu | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMAAVY | NIPOCALIMAB-AAHU | INJECTABLE;INJECTION | 300MG/1.62ML(185MG/ML) | No | No |
| 002 | IMAAVY | NIPOCALIMAB-AAHU | INJECTABLE;INJECTION | 1200MG/6.5ML(185MG/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 |
|---|---|---|---|---|---|---|
| IMAAVY | NIPOCALIMAB-AAHU | Janssen Biotech, Inc. | 8886274c-f2b2-48af-85c1-2f90bfe304b8 | 2026-08-21 | Warnings, Adverse reactions | BLA761430 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.