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
bb502849-12d5-432a-aac2-e4bc0407db3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 12, 2021
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-1397
Application NumberANDA212215
Product Classification
M
Marketing Category
C73584
G
Generic Name
TAVABOROLE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 28, 2019
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TAVABOROLEActive
Quantity: 43.5 mg in 1 mL
Code: K124A4EUQ3
Classification: ACTIB
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT