Last Updated: September 26, 2026

Details for New Drug Application (NDA): 212215

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NDA 212215 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 seven 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. Seven suppliers are listed for this compound. Additional details are available on the tavaborole profile page.

Summary for 212215

Tradename:	TAVABOROLE
Applicant:	Sun Pharma Canada
Ingredient:	tavaborole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	May 7, 2021	TE:		RLD:	No

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