Loprox

As of Nov 14, 2026, NDA 21159 (Loprox), held by Bausch, was first approved by FDA on Feb 28, 2003, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2003
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Feb 28, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loprox1% · shampoo;topical	Ciclopirox	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Apr 7, 2016	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
May 8, 2013	Supplement 20Labeling · Standard review	Approved	Label Letter
Dec 6, 2012	Supplement 19Labeling	Approved	Letter Label
Jun 12, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 26, 2004	Supplement 1Manufacturing · Standard review	Approved	Letter
Feb 28, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21159
Drugs@FDA: Overview at FDA
Company: Bausch Health

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