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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

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

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TRODELVY - FDA Drug Approval Details