Last Updated: November 10, 2026

Details for New Drug Application (NDA): 212256

NDA 212256 describes TAVABOROLE, which is a drug marketed by Alembic, Amneal, Chartwell Rx, Cipla, Encube, Lupin, Padagis Us, Sun Pharma Canada, and Zydus Lifesciences, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the TAVABOROLE profile page.

The generic ingredient in TAVABOROLE is tavaborole. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the tavaborole profile page.

Summary for 212256

Tradename:	TAVABOROLE
Applicant:	Amneal
Ingredient:	tavaborole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	Nov 25, 2020	TE:		RLD:	No

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