Ciclopirox

ANDA 78463, held by Cosette Pharms Nc. Ciclopirox.

As of Nov 15, 2026, ANDA 78463 (Ciclopirox), held by Cosette Pharms Nc, was first approved by FDA on Dec 20, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 20, 2010
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ciclopirox Olamine Cream USP, 0.77% is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 20, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ciclopirox0.77% · cream;topical	Ciclopirox	Rx

All 2 submissions, including labeling and manufacturing supplements


May 21, 2013	Supplement 1Manufacturing	Approved	None posted
Dec 20, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78463
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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