Ciclopirox

ANDA 90273, held by Glenmark Pharms. Ciclopirox.

As of Nov 15, 2026, ANDA 90273 (Ciclopirox), held by Glenmark Pharms, was first approved by FDA on Nov 10, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 10, 2009
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ciclopirox olamine cream 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 3 submissions below

Date	Submission	Status	Documents
Nov 10, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jun 24, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Feb 25, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Nov 10, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90273
Drugs@FDA: Overview at FDA
Company: Glenmark 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