Sertaconazole Nitrate

Sold as Ertaczo. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Sertaconazole Nitrate (sold as Ertaczo), first approved Dec 10, 2003, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 10, 2003
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $3.5M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Ertaczo	Part D	$3.5M	-29%	1,312

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Efficacy of Tropical Sertaconazole Nitrate 2% Vs Clotrimazole 1% for Tinea PedisTinea Pedis · Jinnah Postgraduate Medical Centre	Phase 4	Not yet recruiting	Mar 11, 2025

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Dec 10, 2003	ErtaczoNDA 21385 · New molecular entity	Lacer Pharma	3	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