Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Lifesciences Limited
650650802
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
70771-1826Application Number
ANDA212294Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
April 12, 2023TavaboroleActive
Code: K124A4EUQ3Class: ACTIBQuantity: 43.5 mg in 1 mL
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT