SANCUSO
These highlights do not include all the information needed to use SANCUSO safely and effectively. See full prescribing information for SANCUSO. SANCUSO (granisetron transdermal system) Initial U.S. Approval: 2008
Approved
Approval ID
ba44e7d8-0c71-4eb9-a951-3d91038293c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
Kyowa Kirin, Inc.
DUNS: 014778321
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
granisetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42747-726
Application NumberNDA022198
Product Classification
M
Marketing Category
C73594
G
Generic Name
granisetron
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 15, 2022
FDA Product Classification
INGREDIENTS (4)
HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
granisetronActive
Quantity: 3.1 mg in 24 h
Code: WZG3J2MCOL
Classification: ACTIB
POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL)Inactive
Code: 571593769G
Classification: IACT