Ciclopirox

ANDA 90146, held by Fougera Pharms. Ciclopirox.

As of Nov 15, 2026, ANDA 90146 (Ciclopirox), held by Fougera Pharms, was first approved by FDA on May 25, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: May 25, 2010
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
May 25, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ciclopirox1% · shampoo;topical	Ciclopirox	Rx

All 2 submissions, including labeling and manufacturing supplements


Oct 13, 2023	Supplement 2Labeling · Standard review	Approved	None posted
May 25, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90146
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