Application 761172
- Type
- BLA
- Sponsor
- RIDGEBACK BIOTHERAPEUTICS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EBANGA | ANSUVIMAB-ZYKL | POWDER;IV (INFUSION) | 400MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 80673-777 | EBANGA | ANSUVIMAB | Ridgeback Biotherapeutics, LP | BLA | Current |
| 80673-777 | EBANGA | ANSUVIMAB | Ridgeback Biotherapeutics, LP | BLA | Current |
| 80673-777 | EBANGA | ANSUVIMAB | Ridgeback Biotherapeutics, LP | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85142 | SUPPL | 2026-02-24 |
| 85074 | SUPPL | 2026-02-19 |
| 80769 | SUPPL | 2024-12-27 |
| 80760 | SUPPL | 2024-12-27 |
| 71120 | SUPPL | 2022-05-20 |
| 71110 | SUPPL | 2022-05-20 |
| 69794 | SUPPL | 2021-12-28 |
| 69516 | SUPPL | 2021-12-08 |
| 65897 | ORIG | 2021-01-12 |
| 65695 | ORIG | 2020-12-22 |
| 65650 | ORIG | 2020-12-21 |