Skip to contentApplication 761195
- Type
- BLA
- Sponsor
- ARGENX BV
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VYVGART | EFGARTIGIMOD ALFA | INJECTABLE;INJECTION | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73475-3041 | VYVGART | EFGARTIGIMOD ALFA | argenx US | BLA | Current |
| 73475-3041 | VYVGART | EFGARTIGIMOD ALFA | argenx US | BLA | Current |
| 73475-3041 | VYVGART | EFGARTIGIMOD ALFA | argenx US | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85944 | SUPPL | 2026-05-18 |
| 85874 | SUPPL | 2026-05-11 |
| 83861 | SUPPL | 2025-10-21 |
| 83826 | SUPPL | 2025-10-20 |
| 79364 | SUPPL | 2024-08-12 |
| 79358 | SUPPL | 2024-08-09 |
| 79227 | SUPPL | 2024-07-29 |
| 79206 | SUPPL | 2024-07-25 |
| 76785 | SUPPL | 2023-12-13 |
| 76779 | SUPPL | 2023-12-13 |
| 69909 | ORIG | 2022-01-19 |
| 69723 | ORIG | 2021-12-21 |
| 69636 | ORIG | 2021-12-19 |