Application 761119
- Type
- BLA
- Sponsor
- Lundbeck Seattle BioPharmaceuticals, Inc.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VYEPTI | EPTINEZUMAB-JJMR | INJECTABLE;INJECTION | 100MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67386-130 | Vyepti | eptinezumab-jjmr | Lundbeck Pharmaceuticals LLC | BLA | Current |
| 67386-130 | Vyepti | eptinezumab-jjmr | Lundbeck Pharmaceuticals LLC | BLA | Current |
| 67386-130 | Vyepti | eptinezumab-jjmr | Lundbeck Pharmaceuticals LLC | BLA | Current |
| 67386-130 | Vyepti | eptinezumab-jjmr | Lundbeck Pharmaceuticals LLC | BLA | Current |
| 67386-130 | Vyepti | eptinezumab-jjmr | Lundbeck Pharmaceuticals LLC | BLA | Current |
| 67386-130 | Vyepti | eptinezumab-jjmr | Lundbeck Pharmaceuticals LLC | BLA | Current |
| 67386-130 | Vyepti | eptinezumab-jjmr | Lundbeck Pharmaceuticals LLC | BLA | Current |
| 67386-130 | Vyepti | eptinezumab-jjmr | Lundbeck Pharmaceuticals LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83908 | SUPPL | 2025-10-23 |
| 83899 | SUPPL | 2025-10-23 |
| 81724 | SUPPL | 2025-03-25 |
| 81723 | SUPPL | 2025-03-25 |
| 81701 | SUPPL | 2025-03-24 |
| 81700 | SUPPL | 2025-03-24 |
| 72469 | SUPPL | 2022-10-26 |
| 72454 | SUPPL | 2022-10-24 |
| 68805 | SUPPL | 2021-09-29 |
| 68796 | SUPPL | 2021-09-28 |
| 62234 | ORIG | 2020-03-23 |
| 61947 | ORIG | 2020-02-24 |
| 61944 | ORIG | 2020-02-24 |