Application 761208
- Type
- BLA
- Sponsor
- SEAGEN
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761208 | Tivdak | tisotumab vedotin-tftv | 351(a) | Rx | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIVDAK | TISOTUMAB VEDOTIN-TFTV | INJECTABLE;INJECTION | 40MG | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 3 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51144-003 | TIVDAK | tisotumab vedotin | Seagen Inc. | BLA | Current |
| 51144-003 | TIVDAK | tisotumab vedotin | Seagen Inc. | BLA | Current |
| 51144-003 | TIVDAK | tisotumab vedotin | Seagen Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84157 | SUPPL | 2025-11-13 |
| 84156 | SUPPL | 2025-11-13 |
| 84155 | SUPPL | 2025-11-13 |
| 78310 | SUPPL | 2024-04-30 |
| 78302 | SUPPL | 2024-04-30 |
| 74910 | SUPPL | 2023-07-27 |
| 74902 | SUPPL | 2023-07-27 |
| 68913 | ORIG | 2021-10-07 |
| 68693 | ORIG | 2021-09-21 |
| 68660 | ORIG | 2021-09-20 |
| 68659 | ORIG | 2021-09-20 |