Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Alembic Pharmaceuticals Limited
650574663
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Inc.
Alembic Pharmaceuticals Limited
871411532
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
62332-467Application Number
ANDA212188Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
December 15, 2023TavaboroleActive
Code: K124A4EUQ3Class: ACTIBQuantity: 43.5 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT