TRODELVY
These highlights do not include all the information needed to use TRODELVY safely and effectively. See full prescribing information for TRODELVY TRODELVY (sacituzumab govitecan-hziy) for injection, for intravenous use Initial U.S. Approval: 2020
Approved
Approval ID
57a597d2-03f0-472e-b148-016d7169169d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2023
Manufacturers
FDA
Gilead Sciences
DUNS: 185049848
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SACITUZUMAB GOVITECAN
PRODUCT DETAILS
NDC Product Code55135-132
Application NumberBLA761115
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateFebruary 9, 2023
Generic NameSACITUZUMAB GOVITECAN
INGREDIENTS (4)
SACITUZUMAB GOVITECANActive
Quantity: 180 mg in 1 1
Code: M9BYU8XDQ6
Classification: ACTIB
2-(N-morpholino)ethanesulfonic acidInactive
Code: 2GNK67Q0C4
Classification: IACT
trehaloseInactive
Code: B8WCK70T7I
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT