Tavaborole
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2014
Approved
Approval ID
b59b2319-b3f4-4683-baec-572d00602acb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tavaborole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8704
Application NumberANDA211848
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tavaborole
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 23, 2022
FDA Product Classification
INGREDIENTS (4)
TAVABOROLEActive
Quantity: 43.5 mg in 1 mL
Code: K124A4EUQ3
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT