You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 14, 2025

Details for New Drug Application (NDA): 211297

✉ Email this page to a colleague

« Back to Dashboard

NDA 211297 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 211297

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

Pharmacology for NDA: 211297

Mechanism of Action	Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 211297

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211297	ANDA	Encube Ethicals, Inc.	21922-020	21922-020-12	1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12) / 10 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	Oct 13, 2020	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.