Application 761484
- Type
- BLA
- Sponsor
- JANSSEN BIOTECH
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761484 | Rybrevant Faspro | amivantamab and hyaluronidase-lpuj | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYBREVANT FASPRO | AMIVANTAMAB AND HYALURONIDASE-LPUJ | VIAL; SINGLE-USE | 1,600MG/20,000 UNITS PER 10ML | No | No |
| 002 | RYBREVANT FASPRO | AMIVANTAMAB AND HYALURONIDASE-LPUJ | VIAL; SINGLE-USE | 2,240MG/28,000 UNITS PER 14ML | No | No |
| 003 | RYBREVANT FASPRO | AMIVANTAMAB AND HYALURONIDASE-LPUJ | VIAL; SINGLE-USE | 2,400MG/30,000 UNITS PER 15ML | No | No |
| 004 | RYBREVANT FASPRO | AMIVANTAMAB AND HYALURONIDASE-LPUJ | VIAL; SINGLE-USE | 3,5200MG/44,000 UNITS PER 22ML | 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 |
|---|---|---|---|---|---|---|
| Rybrevant Faspro | AMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT) | Janssen Biotech, Inc. | 9e58b045-e352-4f62-99bf-77fae1bebc69 | 2026-06-17 | Warnings, Adverse reactions | Rybrevant Faspro |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.