Ciclopirox

ANDA 77092, held by Sun Pharma Canada. Ciclopirox.

As of Nov 15, 2026, ANDA 77092 (Ciclopirox), held by Sun Pharma Canada, was first approved by FDA on Aug 10, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 10, 2005
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
Aug 10, 2005	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Oct 28, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 10, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77092
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