Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Encube Ethicals Private Limited
Encube Ethicals Private Limited
725076298
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tavaborole
Product Details
NDC Product Code
21922-020Application Number
ANDA211297Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
October 29, 2020TavaboroleActive
Code: K124A4EUQ3Class: ACTIBQuantity: 43.5 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT