Application 761342
- Type
- BLA
- Sponsor
- JANSSEN BIOTECH
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761342 | Talvey | talquetamab-tgvs | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TALVEY | TALQUETAMAB-TGVS | INJECTABLE;INJECTION | 3MG/1.5ML(2MG/ML) | No | No |
| 002 | TALVEY | TALQUETAMAB-TGVS | INJECTABLE;INJECTION | 40MG/ML | 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 |
|---|
| 85851 | SUPPL | 2026-05-08 |
| 85293 | SUPPL | 2026-03-09 |
| 83658 | SUPPL | 2025-10-03 |
| 83654 | SUPPL | 2025-10-03 |
| 83653 | SUPPL | 2025-10-03 |
| 83161 | SUPPL | 2025-08-20 |
| 80486 | SUPPL | 2024-12-03 |
| 78979 | SUPPL | 2024-07-05 |
| 77589 | SUPPL | 2024-02-21 |
| 76656 | SUPPL | 2023-11-24 |
| 75589 | ORIG | 2023-09-28 |
| 75357 | ORIG | 2023-09-07 |
| 75026 | ORIG | 2023-08-10 |
| 75025 | ORIG | 2023-08-10 |