Home Applications 761208 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 2026-06-01
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
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TIVDAK TISOTUMAB VEDOTIN SEAGEN INC. c9fe3f32-4219-466e-acb9-3f609b4f4df1 2025-11-20 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761208 ndc (product): 51144-003
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 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