Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Taro Pharmaceuticals Inc.
Taro Pharmaceuticals U.S.A., Inc.
206263295
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
51672-1397Application Number
ANDA212215Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
May 28, 2019ALCOHOLInactive
Code: 3K9958V90MClass: IACT
TavaboroleActive
Code: K124A4EUQ3Class: ACTIBQuantity: 43.5 mg in 1 mL
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT