TIVDAK
These highlights do not include all the information needed to use TIVDAK safely and effectively. See full prescribing information for TIVDAK. TIVDAK (tisotumab vedotin-tftv) for injection, for intravenous use Initial U.S. Approval: 2021
Approved
Approval ID
c9fe3f32-4219-466e-acb9-3f609b4f4df1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2023
Manufacturers
FDA
Seagen Inc.
DUNS: 028484371
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tisotumab vedotin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51144-003
Application NumberBLA761208
Product Classification
M
Marketing Category
C73585
G
Generic Name
tisotumab vedotin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (5)
Tisotumab VedotinActive
Quantity: 40 mg in 4 mL
Code: T41737F88A
Classification: ACTIB
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Histidine Monohydrochloride MonohydrateInactive
Code: X573657P6P
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
HistidineInactive
Code: 4QD397987E
Classification: IACT