Loprox

NDA 19824, held by Eurofarma. Ciclopirox.

As of Nov 13, 2026, NDA 19824 (Loprox), held by Eurofarma, was first approved by FDA on Dec 30, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1988
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 30, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loprox0.77% · suspension;topical	Ciclopirox	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Nov 4, 2025	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 4, 2016	Supplement 24Manufacturing	Approved	None posted
Jun 28, 2013	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 26, 2003	Supplement 8Labeling · Standard review	Approved	Letter Label
Mar 26, 2003	Supplement 9Labeling · Standard review	Approved	Letter Label
Jun 9, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 17, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 23, 1995	Supplement 3Labeling	Approved	None posted
Sep 11, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
May 8, 1989	Supplement 1Labeling	Approved	None posted
Dec 30, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19824
Drugs@FDA: Overview at FDA
Company: Eurofarma

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