| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 761304 | BLA | ARGENX BV | 001 | VYVGART HYTRULO | INJECTABLE;INJECTION | 1008MG;11200UNITS PER 5.6ML | EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC | 2023-06-20 | Prescription | No | |
| 761195 | BLA | ARGENX BV | 001 | VYVGART | INJECTABLE;INJECTION | 400MG | EFGARTIGIMOD ALFA | 2021-12-17 | Prescription | No |