Application 761071
- Type
- BLA
- Sponsor
- SANDOZ INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | Rx | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYRIMOZ | ADALIMUMAB-ADAZ | INJECTABLE;INJECTION | 40MG/0.8ML | 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 |
|---|---|---|---|---|---|---|
| Adalimumab | ADALIMUMAB-ADAZ | Sandoz Inc | 3468792f-63ef-4916-8ed1-8214f327d9dd | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | BLA761071 |
| HYRIMOZ | ADALIMUMAB-ADAZ | Cordavis Limited | 3e303a4a-980b-4f2a-9d03-786928758637 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | BLA761071 |
| HYRIMOZ | ADALIMUMAB-ADAZ | Sandoz Inc | 1ac7d061-3380-468c-b077-c05f8dfbc829 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | BLA761071 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83835 | SUPPL | 2025-10-21 |
| 83834 | SUPPL | 2025-10-21 |
| 83807 | SUPPL | 2025-10-20 |
| 82999 | SUPPL | 2025-07-31 |
| 82990 | SUPPL | 2025-07-30 |
| 82217 | SUPPL | 2025-05-21 |
| 82231 | SUPPL | 2025-05-20 |
| 78795 | SUPPL | 2024-06-13 |
| 78785 | SUPPL | 2024-06-13 |
| 78097 | SUPPL | 2024-04-09 |
| 78081 | SUPPL | 2024-04-08 |
| 75442 | SUPPL | 2023-09-13 |
| 75389 | SUPPL | 2023-09-11 |
| 74013 | SUPPL | 2023-04-17 |
| 74005 | SUPPL | 2023-04-17 |
| 73866 | SUPPL | 2023-03-27 |
| 73811 | SUPPL | 2023-03-23 |
| 71613 | SUPPL | 2022-07-20 |
| 71612 | SUPPL | 2022-07-20 |
| 71611 | SUPPL | 2022-07-20 |
| 71591 | SUPPL | 2022-07-19 |
| 71590 | SUPPL | 2022-07-19 |
| 70647 | SUPPL | 2022-03-29 |
| 70646 | SUPPL | 2022-03-29 |
| 70641 | SUPPL | 2022-03-29 |
| 66409 | SUPPL | 2021-02-26 |
| 66408 | SUPPL | 2021-02-26 |
| 66362 | SUPPL | 2021-02-25 |
| 58054 | ORIG | 2019-03-21 |
| 56217 | ORIG | 2019-02-28 |
| 56394 | ORIG | 2018-11-09 |
| 56201 | ORIG | 2018-10-31 |