Application 761291
- Type
- BLA
- Sponsor
- JANSSEN BIOTECH
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761291 | Tecvayli | teclistamab-cqyv | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TECAYLI | TECLISTAMAB-CQYV | INJECTABLE;INJECTION | 30MG/3ML(10MG/ML) | No | No |
| 002 | TECAYLI | TECLISTAMAB-CQYV | INJECTABLE;INJECTION | 153MG/1.7ML(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 |
|---|---|---|---|---|---|---|
| TECVAYLI | TECLISTAMAB-CQYV | Janssen Biotech, Inc. | 54e0f974-ccee-44ea-9254-40e9883cee1e | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | BLA761291 57894-449 57894-450 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57894-449 | TECVAYLI | teclistamab | Janssen Biotech, Inc. | BLA | Current |
| 57894-449 | TECVAYLI | teclistamab | Janssen Biotech, Inc. | BLA | Current |
| 57894-450 | TECVAYLI | teclistamab | Janssen Biotech, Inc. | BLA | Current |
| 57894-450 | TECVAYLI | teclistamab | Janssen Biotech, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85850 | SUPPL | 2026-05-08 |
| 85345 | SUPPL | 2026-03-12 |
| 85292 | SUPPL | 2026-03-09 |
| 85354 | SUPPL | 2026-03-05 |
| 83657 | SUPPL | 2025-10-03 |
| 83164 | SUPPL | 2025-08-21 |
| 83160 | SUPPL | 2025-08-20 |
| 80485 | SUPPL | 2024-12-03 |
| 78978 | SUPPL | 2024-07-05 |
| 78585 | SUPPL | 2024-05-30 |
| 78571 | SUPPL | 2024-05-29 |
| 77591 | SUPPL | 2024-02-21 |
| 77587 | SUPPL | 2024-02-21 |
| 76657 | SUPPL | 2023-11-24 |
| 75591 | SUPPL | 2023-09-28 |
| 75587 | APPL | 2023-09-28 |
| 75038 | SUPPL | 2023-08-10 |
| 75031 | SUPPL | 2023-08-10 |
| 72683 | ORIG | 2022-11-23 |
| 72481 | ORIG | 2022-10-27 |
| 72465 | ORIG | 2022-10-26 |