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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 212294

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NDA 212294 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 212294

Tradename:	TAVABOROLE
Applicant:	Zydus Lifesciences
Ingredient:	tavaborole
Patents:	0

Pharmacology for NDA: 212294

Mechanism of Action	Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 212294

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212294	ANDA	Zydus Lifesciences Limited	70771-1826	70771-1826-0	1 BOTTLE, WITH APPLICATOR in 1 CARTON (70771-1826-0) / 10 mL in 1 BOTTLE, WITH APPLICATOR
TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212294	ANDA	Viona Pharmaceuticals Inc	72578-102	72578-102-04	1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-102-04) / 10 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	Apr 10, 2023	TE:	AB	RLD:	No

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