Klisyri
These highlights do not include all the information needed to use KLISYRI safely and effectively. See full prescribing information for KLISYRI. KLISYRI (tirbanibulin) ointment, for topical use Initial U.S. Approval: 2020
Approved
Approval ID
589c8de8-b773-4d47-b60c-48471806cccc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Almirall, LLC
DUNS: 605425912
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tirbanibulin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16110-391
Application NumberNDA213189
Product Classification
M
Marketing Category
C73594
G
Generic Name
tirbanibulin
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (3)
TIRBANIBULINActive
Quantity: 10 mg in 1 g
Code: 4V9848RS5G
Classification: ACTIB
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT