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
dc68c727-a77a-432e-8308-e88aea241b58
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2021
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
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 Code0574-0157
Application NumberANDA211848
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tavaborole
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (4)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
TAVABOROLEActive
Quantity: 43.5 mg in 1 mL
Code: K124A4EUQ3
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT