Tavaborole
Tavaborole Topical Solution 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 solution Initial U.S. Approval: 2014
Approved
Approval ID
7fe75d38-80a0-444e-84bc-4087b45a791e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-663
Application NumberANDA211963
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tavaborole
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2023
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TAVABOROLEActive
Quantity: 43.5 mg in 1 mL
Code: K124A4EUQ3
Classification: ACTIB