Application 761140
- Type
- BLA
- Sponsor
- AMGEN INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761140 | Riabni | rituximab-arrx | 351(k) Biosimilar | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RIABNI | RITUXIMAB-ARRX | INJECTABLE;INJECTION | 100MG/10ML(10MG/ML) | Yes | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|
| 55513-224 | Riabni | rituximab-arrx | Amgen Inc | BLA | Current |
| 55513-224 | Riabni | rituximab-arrx | Amgen Inc | BLA | Current |
| 55513-326 | Riabni | rituximab-arrx | Amgen Inc | BLA | Current |
| 55513-326 | Riabni | rituximab-arrx | Amgen Inc | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82523 | SUPPL | 2025-06-10 |
| 82521 | SUPPL | 2025-06-10 |
| 82515 | SUPPL | 2025-06-10 |
| 71220 | SUPPL | 2022-06-06 |
| 71217 | SUPPL | 2022-06-06 |
| 71216 | SUPPL | 2022-06-06 |
| 65984 | ORIG | 2021-01-26 |
| 65646 | ORIG | 2020-12-21 |
| 65614 | ORIG | 2020-12-17 |
| 65613 | ORIG | 2020-12-17 |