Ciclopirox

ANDA 77364, held by Padagis Israel. Ciclopirox.

As of Nov 15, 2026, ANDA 77364 (Ciclopirox), held by Padagis Israel, was first approved by FDA on Mar 3, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 3, 2006
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
Mar 3, 2006	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


Mar 6, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Mar 6, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Mar 3, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77364
Drugs@FDA: Overview at FDA
Company: Padagis Israel

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