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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 212188

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NDA 212188 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 212188

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

Pharmacology for NDA: 212188

Mechanism of Action	Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 212188

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212188	ANDA	Alembic Pharmaceuticals Limited	46708-467	46708-467-04	1 BOTTLE, DROPPER in 1 CARTON (46708-467-04) / 4 mL in 1 BOTTLE, DROPPER
TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212188	ANDA	Alembic Pharmaceuticals Limited	46708-467	46708-467-10	1 BOTTLE, DROPPER in 1 CARTON (46708-467-10) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	Oct 21, 2020	TE:	AB	RLD:	No

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