Application 761202
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761202 | Byooviz | ranibizumab-nuna | 351(k) Interchangeable | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BYOOVIZ | RANIBIZUMAB-NUNA | INJECTABLE;INJECTION | 0.5MG(10MG/ML) | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Byooviz | RANIBIZUMAB-NUNA | BIOGEN INC. | e46db299-edd1-4457-89b2-c1e2e505f1b0 | 2025-12-01 | Warnings, Adverse reactions | BLA761202 64406-019 |
| Byooviz | RANIBIZUMAB-NUNA | Harrow Eye, LLC | 77b53b2c-da0e-44b2-ade4-b08ff75a7584 | 2025-11-26 | Warnings, Adverse reactions | BLA761202 |
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85613 | SUPPL | 2026-03-31 |
| 85607 | SUPPL | 2026-03-31 |
| 84158 | SUPPL | 2025-11-13 |
| 84147 | SUPPL | 2025-11-13 |
| 83121 | SUPPL | 2025-08-18 |
| 83115 | SUPPL | 2025-08-18 |
| 75676 | SUPPL | 2023-10-05 |
| 75673 | SUPPL | 2023-10-05 |
| 74565 | SUPPL | 2023-06-21 |
| 74555 | SUPPL | 2023-06-20 |
| 71812 | SUPPL | 2022-08-16 |
| 71288 | SUPPL | 2022-06-13 |
| 71262 | SUPPL | 2022-06-10 |
| 68828 | ORIG | 2021-10-01 |
| 68692 | ORIG | 2021-09-21 |
| 68669 | ORIG | 2021-09-20 |