Ciclopirox

ANDA 77676, held by Padagis Israel. Ciclopirox.

As of Nov 15, 2026, ANDA 77676 (Ciclopirox), held by Padagis Israel, was first approved by FDA on Dec 15, 2006, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 15, 2006
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ciclopirox Topical Suspension USP, 0.77% (w/w) (Lotion) 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; cutaneous 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 15, 2006	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Apr 10, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Dec 15, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77676
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