Application 761484
- Type
- BLA
- Sponsor
- JANSSEN BIOTECH
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 |