Tavaborole
These highlights do not include all the information needed to use TAVABOROLE TOPICAL SOLUTION safely and effectively. See full prescribing information for TAVABOROLE TOPICAL SOLUTION. TAVABOROLE topical solutionInitial U.S. Approval: 2014
Approved
Approval ID
c13610c8-c57a-4519-b37d-eb4fbdcec398
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2023
Manufacturers
FDA
Viona Pharmaceuticals Inc
DUNS: 081468959
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 Code72578-102
Application NumberANDA212294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tavaborole
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 12, 2023
FDA Product Classification
INGREDIENTS (4)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
TAVABOROLEActive
Quantity: 43.5 mg in 1 mL
Code: K124A4EUQ3
Classification: ACTIB