Application 761054
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
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, 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 |