Ciclopirox

ANDA 77896, held by Fougera Pharms. Ciclopirox.

As of Nov 15, 2026, ANDA 77896 (Ciclopirox), held by Fougera Pharms, was first approved by FDA on Jun 10, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 10, 2008
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 10, 2008	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jun 27, 2011	Supplement 2Labeling	Approved	None posted
Jun 10, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77896
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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