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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55135-132
Application NumberBLA761115
Product Classification
M
Marketing Category
C73585
G
Generic Name
SACITUZUMAB GOVITECAN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 9, 2023
FDA Product Classification

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

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