Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Lifesciences Limited
650199482
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Viona Pharmaceuticals Inc
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
72578-102Application Number
ANDA212294Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
April 12, 2023PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
TavaboroleActive
Code: K124A4EUQ3Class: ACTIBQuantity: 43.5 mg in 1 mL