FdaApplication
BLA 761484
Identifiers
- fda_app_no: BLA761484
Properties
| Property | Value |
|---|---|
| applicant_name | Janssen Biotech, Inc. |
| application_type | BLA |
| approval_date | 2026-02-13 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RYBREVANT FASPRO | AMIVANTAMAB AND HYALURONIDASE-LPUJ | 1,600MG/10ML; 20,000UNITS/10ML (160MG/2,000UNITS/ML) | VIAL;SINGLE-USE |
| RYBREVANT FASPRO | AMIVANTAMAB AND HYALURONIDASE-LPUJ | 2,400MG/15ML; 30,000UNITS (160MG/2,000UNITS/ML) | VIAL;SINGLE-USE |
| RYBREVANT FASPRO | AMIVANTAMAB AND HYALURONIDASE-LPUJ | 2,240MG/14ML; 28,000UNITS/14ML (160MG/2,000UNITS/ML) | VIAL;SINGLE-USE |
| RYBREVANT FASPRO | AMIVANTAMAB AND HYALURONIDASE-LPUJ | 3,520MG/22ML; 44,000UNITS (160MG/2,000UNITS/ML) | VIAL;SINGLE-USE |
4 products