Application 761181
- Type
- BLA
- Sponsor
- REGENERON PHARMACEUTICALS
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761181 | Evkeeza | evinacumab-dgnb | 351(a) | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EVKEEZA | EVINACUMAB-DGNB | SOLUTION; INJECTION | 345MG/2.3ML | No | No |
| 002 | EVKEEZA | EVINACUMAB-DGNB | SOLUTION; INJECTION | 1200MG/8ML | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 4 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61755-010 | Evkeeza | evinacumab | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-010 | Evkeeza | evinacumab | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-013 | Evkeeza | evinacumab | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-013 | Evkeeza | evinacumab | Regeneron Pharmaceuticals, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83554 | SUPPL | 2025-09-26 |
| 83546 | SUPPL | 2025-09-26 |
| 73820 | SUPPL | 2023-03-23 |
| 73819 | SUPPL | 2023-03-22 |
| 66747 | ORIG | 2021-03-11 |
| 66235 | ORIG | 2021-02-16 |
| 66214 | ORIG | 2021-02-16 |