Ciclopirox

Treats seborrheic dermatitis of the scalp. ANDA 90269, held by Sun Pharma Canada. Ciclopirox.

As of Nov 15, 2026, ANDA 90269 (Ciclopirox), held by Sun Pharma Canada, was first approved by FDA on Feb 23, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 23, 2011
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ciclopirox Shampoo 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.

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
Feb 23, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Oct 8, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Feb 23, 2011	Original application	Approved	None posted
Feb 23, 2011	Supplement 23	Approved	None posted

Identifiers

Application: ANDA 90269
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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