Tavaborole

Sold as Kerydin. Every FDA application for this active ingredient: 1 branded and 9 generic.

As of Nov 13, 2026, FDA lists 10 applications for Tavaborole (sold as Kerydin), first approved Jul 7, 2014, with 1 new use approved and 0 published complete response letters.

First approved: Jul 7, 2014
Applications: 10
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $29.3M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Tavaborole	Part D	$29.3M	+43%	12,551

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 7, 2014	KerydinNDA 204427 · New molecular entity	Anacor Pharms Inc	6	Discontinued
Oct 13, 2020	TavaboroleANDA 211297	Encube	0	Marketed
Oct 13, 2020	TavaboroleANDA 211848	Padagis US	0	Discontinued
Oct 21, 2020	TavaboroleANDA 212188	Alembic	0	Marketed
Nov 25, 2020	TavaboroleANDA 212256	Amneal	0	Discontinued
Feb 3, 2021	TavaboroleANDA 211963	Chartwell Rx	0	Marketed
Feb 8, 2021	TavaboroleANDA 212168	Lupin	0	Discontinued
Feb 9, 2021	TavaboroleANDA 212224	Cipla	0	Discontinued
May 7, 2021	TavaboroleANDA 212215	Sun Pharma Canada	0	Discontinued
Apr 10, 2023	TavaboroleANDA 212294	Zydus Lifesciences	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA