| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 761324 | BLA | GENMAB US, INC. | 001 | EPKINLY | INJECTABLE;SUBCUTANEOUS | 4MG/0.8ML | EPCORITAMAB-BYSP | 2023-05-19 | Prescription | No | |
| 002 | EPKINLY | INJECTABLE;SUBCUTANEOUS | 48MG/0.8ML | EPCORITAMAB-BYSP | 2023-05-19 | Prescription | No |