Application 761066
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761066 | Eticovo | etanercept-ykro | 351(k) Interchangeable | Disc | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ETICOVO | ETANERCEPT-YKRO | INJECTABLE;INJECTION | 25MG/0.5ML | No | No |
| 002 | ETICOVO | ETANERCEPT-YKRO | INJECTABLE;INJECTION | 50MG/1ML | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 2 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71202-003 | Eticovo | etanercept | Samsung Bioepis Co., Ltd. | BLA | Current |
| 71202-004 | Eticovo | etanercept | Samsung Bioepis Co., Ltd. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84404 | SUPPL | 2025-12-15 |
| 84366 | SUPPL | 2025-12-09 |
| 78924 | SUPPL | 2024-06-27 |
| 78923 | SUPPL | 2024-06-27 |
| 78901 | SUPPL | 2024-06-26 |
| 78410 | SUPPL | 2024-05-07 |
| 59107 | ORIG | 2019-06-18 |
| 58453 | ORIG | 2019-04-29 |
| 58441 | ORIG | 2019-04-26 |
| 58440 | ORIG | 2019-04-26 |