Tavaborole
Tavaborole Topical Solution
Approved
Approval ID
15bc62dc-4f5e-4d43-a125-d1f00bee84a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1826
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)
TAVABOROLEActive
Quantity: 43.5 mg in 1 mL
Code: K124A4EUQ3
Classification: ACTIB
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT