YONDELIS
These highlights do not include all the information needed to use YONDELIS safely and effectively. See full prescribing information for YONDELIS. YONDELIS (trabectedin) for injection, for intravenous useInitial U.S. Approval: 2015
Approved
Approval ID
472bd78e-be17-4b9d-90f4-9482c3aec9ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2020
Manufacturers
FDA
Janssen Products, LP
DUNS: 804684207
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trabectedin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-610
Application NumberNDA207953
Product Classification
M
Marketing Category
C73594
G
Generic Name
Trabectedin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2018
FDA Product Classification
INGREDIENTS (5)
TrabectedinActive
Quantity: 0.05 mg in 1 mL
Code: ID0YZQ2TCP
Classification: ACTIB
SucroseInactive
Code: C151H8M554
Classification: IACT
Potassium Phosphate, MonobasicInactive
Code: 4J9FJ0HL51
Classification: IACT
Potassium HydroxideInactive
Code: WZH3C48M4T
Classification: IACT
Phosphoric AcidInactive
Code: E4GA8884NN
Classification: IACT