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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 212256

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

The generic ingredient in TAVABOROLE is tavaborole. There are six drug master file entries for this compound. Seven 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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