Application 761344
- Type
- BLA
- Sponsor
- AMGEN INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761344 | Imdelltra | tarlatamab-dlle | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMDELLTRA | TARLATAMAB-DLLE | INJECTABLE;INJECTION | 1MG | No | No |
| 002 | IMDELLTRA | TARLATAMAB-DLLE | INJECTABLE;INJECTION | 10MG | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84250 | SUPPL | 2025-11-21 |
| 84238 | SUPPL | 2025-11-20 |
| 84237 | SUPPL | 2025-11-20 |
| 78915 | ORIG | 2024-06-27 |
| 78506 | ORIG | 2024-05-20 |
| 78485 | ORIG | 2024-05-16 |