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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 212168

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NDA 212168 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 eight 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. Eight suppliers are listed for this compound. Additional details are available on the tavaborole profile page.

Summary for 212168

Tradename:	TAVABOROLE
Applicant:	Lupin Ltd
Ingredient:	tavaborole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	Feb 8, 2021	TE:	AB	RLD:	No

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