Application 761343
- Type
- BLA
- Sponsor
- ALVOTECH USA INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761343 | Selarsdi | ustekinumab-aekn | 351(k) Interchangeable | Rx | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SELARSDI | USTEKINUMAB-AEKN | INJECTABLE;INJECTION | 45MG/0.5ML | No | No |
| 002 | SELARSDI | USTEKINUMAB-AEKN | INJECTABLE;INJECTION | 90MG/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 |
|---|---|---|---|---|---|---|
| Ustekinumab-aekn | USTEKINUMAB-AEKN | Teva Pharmaceuticals USA, Inc. | 183a1dff-ef33-4ddb-ba38-f7861b0f77ad | 2026-07-30 | Warnings, Adverse reactions | BLA761343 |
| Ustekinumab-aekn | USTEKINUMAB-AEKN | Teva Pharmaceuticals USA, Inc. | 052a3fb2-21c3-4c4e-a01e-afdd1accd1cd | 2026-07-24 | Warnings, Adverse reactions | BLA761343 |
| Selarsdi | USTEKINUMAB-AEKN | Teva Pharmaceuticals USA, Inc. | 87f75b59-e48b-47c7-a4c0-5fe5965660e7 | 2026-06-24 | Warnings, Adverse reactions | BLA761343 |
| SELARSDI | USTEKINUMAB-AEKN | A-S Medication Solutions | b3b483f4-3426-4d6d-97ae-39848ec1bfae | 2025-11-20 | Warnings, Adverse reactions | BLA761343 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84351 | SUPPL | 2025-12-08 |
| 84347 | SUPPL | 2025-12-02 |
| 84249 | SUPPL | 2025-11-21 |
| 84248 | SUPPL | 2025-11-21 |
| 82152 | SUPPL | 2025-05-05 |
| 82268 | SUPPL | 2025-04-30 |
| 82267 | SUPPL | 2025-04-30 |
| 81636 | SUPPL | 2025-03-19 |
| 81635 | SUPPL | 2025-03-19 |
| 79955 | SUPPL | 2024-10-22 |
| 79951 | SUPPL | 2024-10-21 |
| 79950 | SUPPL | 2024-10-21 |
| 79949 | SUPPL | 2024-10-21 |
| 79947 | SUPPL | 2024-10-21 |
| 79932 | SUPPL | 2024-10-21 |
| 79931 | SUPPL | 2024-10-21 |
| 78885 | ORIG | 2024-06-25 |
| 78153 | ORIG | 2024-04-17 |
| 78152 | ORIG | 2024-04-16 |