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FDA Approval

SANCUSO

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Kyowa Kirin, Inc.
DUNS: 014778321
Effective Date
August 24, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Granisetron(3.1 mg in 24 h)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Kindeva Drug Delivery L.P.

Kyowa Kirin, Inc.

128688199

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SANCUSO

Product Details

NDC Product Code
42747-726
Application Number
NDA022198
Marketing Category
NDA (C73594)
Route of Administration
TRANSDERMAL
Effective Date
December 15, 2022
HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Code: WZG3J2MCOLClass: ACTIBQuantity: 3.1 mg in 24 h
POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL)Inactive
Code: 571593769GClass: IACT
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