Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Cipla USA Inc.
078719707
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Encube Ethicals Private Limited
Cipla USA Inc.
Cipla USA Inc.
725076298
AZICO BIOPHORE INDIA PRIVATE LIMITED
Cipla USA Inc.
Cipla USA Inc.
860186984
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
69097-686Application Number
ANDA212224Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
January 9, 2024TavaboroleActive
Code: K124A4EUQ3Class: ACTIBQuantity: 43.5 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT