Tavaborole

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 079394054

Effective Date

September 15, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tavaborole(43.5 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

62135-663

Application Number

ANDA211963

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

September 15, 2023

Ingredients

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

EDETATE CALCIUM DISODIUMInactive

Code: 25IH6R4SGFClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: K124A4EUQ3Class: ACTIBQuantity: 43.5 mg in 1 mL