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
37004451-0345-4e00-96be-f05db600fb9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-686
Application NumberANDA212224
Product Classification
M
Marketing Category
C73584
G
Generic Name
TAVABOROLE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (4)
TAVABOROLEActive
Quantity: 43.5 mg in 1 mL
Code: K124A4EUQ3
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT