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 solution Initial U.S. Approval: 2014
Approved
Approval ID
050f5d10-5591-426e-9020-6516b3363304
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2022
Manufacturers
FDA
Encube Ethicals Private Limited
DUNS: 915834105
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TAVABOROLE topical solution, 5%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21922-020
Application NumberANDA211297
Product Classification
M
Marketing Category
C73584
G
Generic Name
TAVABOROLE topical solution, 5%
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 29, 2020
FDA Product Classification
INGREDIENTS (4)
TAVABOROLEActive
Quantity: 43.5 mg in 1 mL
Code: K124A4EUQ3
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT