Application 761299
- Type
- BLA
- Sponsor
- ALVOTECH USA INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761299 | Simlandi | adalimumab-ryvk | 351(k) Interchangeable | Rx | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIMLANDI | ADALIMUMAB-RYVK | INJECTABLE;INJECTION | 40MG/0.4ML | 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-ryvk | ADALIMUMAB-RYVK | Teva Pharmaceuticals USA, Inc. | f8c0d3c2-b5ed-4bb8-927c-5c5529343ee6 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | BLA761299 |
| Adalimumab-ryvk | ADALIMUMAB-RYVK | Quallent Pharmaceuticals Health LLC | dce1590f-9e47-4c4d-9437-cfb18b779a75 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | BLA761299 |
| Adalimumab-ryvk | ADALIMUMAB-RYVK | Teva Pharmaceuticals USA, Inc. | 2d19a877-1f5a-4731-800a-dddadc424080 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | BLA761299 |
| Simlandi | ADALIMUMAB-RYVK | Teva Pharmaceuticals USA, Inc. | 12f609c9-2088-bb05-e063-6394a90a9ecc | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | BLA761299 |
| Simlandi | ADALIMUMAB-RYVK | A-S Medication Solutions | ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | BLA761299 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84129 | SUPPL | 2025-11-07 |
| 84125 | SUPPL | 2025-11-07 |
| 83837 | SUPPL | 2025-10-21 |
| 83836 | SUPPL | 2025-10-21 |
| 83805 | SUPPL | 2025-10-20 |
| 81916 | SUPPL | 2025-04-09 |
| 81915 | SUPPL | 2025-04-09 |
| 81843 | SUPPL | 2025-04-08 |
| 81842 | SUPPL | 2025-04-08 |
| 81299 | SUPPL | 2025-02-20 |
| 81266 | SUPPL | 2025-02-18 |
| 79499 | SUPPL | 2024-08-29 |
| 79498 | SUPPL | 2024-08-29 |
| 79490 | SUPPL | 2024-08-27 |
| 79489 | SUPPL | 2024-08-27 |
| 78976 | SUPPL | 2024-07-05 |
| 78763 | ORIG | 2024-06-11 |
| 78622 | SUPPL | 2024-06-04 |
| 78614 | SUPPL | 2024-06-03 |
| 77625 | ORIG | 2024-02-26 |
| 77620 | ORIG | 2024-02-23 |