Penlac

NDA 21022, held by Valeant Bermuda. Ciclopirox.

As of Nov 14, 2026, NDA 21022 (Penlac), held by Valeant Bermuda, was first approved by FDA on Dec 17, 1999, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1999
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 17, 1999	Original applicationNew dosage form · Standard review	Approved	Letter Label Review Patient Package Insert

Products

1 strengths and forms

Product	Active ingredient	Marketing
Penlac8% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;topical	Ciclopirox	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Dec 3, 2004	Supplement 4Labeling · Standard review	Approved	Label Letter
Dec 22, 2003	Supplement 3Labeling · Standard review	Approved	Label Letter
Jun 9, 2003	Supplement 2Labeling · Standard review	Approved	Label Letter
Feb 9, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 17, 1999	Original applicationNew dosage form · Standard review	Approved	Letter Label Review Patient Package Insert

Identifiers

Application: NDA 21022
Drugs@FDA: Overview at FDA
Company: Valeant Bermuda

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