Application 761430
- Type
- BLA
- Sponsor
- JANSSEN BIOTECH
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 |