Ertaczo

NDA 21385, held by Lacer Pharma. Sertaconazole Nitrate.

As of Nov 15, 2026, NDA 21385 (Ertaczo), held by Lacer Pharma, was first approved by FDA on Dec 10, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 10, 2003
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ERTACZO cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 10, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ertaczo2% · cream;topical	Sertaconazole Nitrate	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Dec 17, 2020	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 22, 2014	Supplement 5Labeling · Standard review	Approved	Letter Label
Nov 22, 2005	Supplement 3Manufacturing · Standard review	Approved	Letter
Dec 10, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21385
Drugs@FDA: Overview at FDA
Company: Lacer Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters