Application 761054
- 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 |
|---|
| 761054 | Renflexis | infliximab-abda | 351(k) Biosimilar | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RENFLEXIS | INFLIXIMAB-ABDA | INJECTABLE;INJECTION | 100MG | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 9 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0006-4305 | Renflexis | infliximab | Merck Sharp & Dohme Corp. | BLA | Current |
| 0006-4305 | Renflexis | infliximab | Merck Sharp & Dohme Corp. | BLA | Current |
| 0006-4305 | Renflexis | infliximab | Merck Sharp & Dohme Corp. | BLA | Current |
| 0006-4305 | Renflexis | infliximab | Merck Sharp & Dohme Corp. | BLA | Current |
| 0006-4305 | Renflexis | infliximab | Merck Sharp & Dohme Corp. | BLA | Current |
| 0006-4305 | Renflexis | infliximab | Merck Sharp & Dohme Corp. | BLA | Current |
| 0006-4305 | Renflexis | infliximab | Merck Sharp & Dohme Corp. | BLA | Current |
| 78206-162 | Renflexis | infliximab | Organon LLC | BLA | Current |
| 78206-162 | Renflexis | infliximab | Organon LLC | BLA | Current |