Application 761058
- Type
- BLA
- Sponsor
- BOEHRINGER INGELHEIM
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761058 | Cyltezo | adalimumab-adbm | 351(k) Interchangeable | Rx | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYLTEZO | ADALIMUMAB-ADBM | 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 |
|---|---|---|---|---|---|---|
| Cyltezo | ADALIMUMAB-ADBM | Boehringer Ingelheim Pharmaceuticals, Inc. | 115ea79b-7209-7f19-b35d-36ec0828fbf5 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | BLA761058 |
| Adalimumab-adbm | ADALIMUMAB-ADBM | Boehringer Ingelheim Pharmaceuticals, Inc. | 62f39a7c-00df-4519-a8d4-39bbd0a649ed | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | BLA761058 |
| Adalimumab-adbm | ADALIMUMAB-ADBM | QUALLENT PHARMACEUTICALS HEALTH LLC | f9986706-9c75-4335-a54f-09d7716dbcef | 2024-11-12 | Boxed warning, Warnings, Adverse reactions | BLA761058 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83872 | SUPPL | 2025-10-22 |
| 83871 | SUPPL | 2025-10-22 |
| 83808 | SUPPL | 2025-10-20 |
| 82220 | SUPPL | 2025-05-21 |
| 82233 | SUPPL | 2025-05-20 |
| 78394 | SUPPL | 2024-05-03 |
| 78393 | SUPPL | 2024-05-03 |
| 74865 | SUPPL | 2023-07-21 |
| 74804 | SUPPL | 2023-07-20 |
| 74683 | SUPPL | 2023-07-03 |
| 74337 | SUPPL | 2023-05-22 |
| 74317 | SUPPL | 2023-05-19 |
| 73828 | SUPPL | 2023-03-23 |
| 73825 | SUPPL | 2023-03-23 |
| 73393 | SUPPL | 2023-02-06 |
| 73392 | SUPPL | 2023-02-06 |
| 72255 | SUPPL | 2022-10-05 |
| 72240 | SUPPL | 2022-10-04 |
| 69037 | SUPPL | 2021-10-20 |
| 69017 | SUPPL | 2021-10-19 |
| 69016 | SUPPL | 2021-10-19 |
| 60017 | SUPPL | 2019-09-17 |
| 60006 | SUPPL | 2019-09-16 |
| 60005 | SUPPL | 2019-09-16 |
| 55638 | ORIG | 2018-09-27 |
| 49546 | ORIG | 2017-08-28 |
| 49544 | ORIG | 2017-08-25 |