Lexette

NDA 210566, held by Mayne Pharma. Halobetasol Propionate.

As of Nov 14, 2026, NDA 210566 (Lexette), held by Mayne Pharma, was first approved by FDA on May 24, 2018, with 4 approved supplements and 0 published complete response letters.

First approved: May 24, 2018
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


Aug 18, 2021	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 24, 2018	Original applicationTYPE 3/4 · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lexette0.05% · aerosol, foam;topical	Halobetasol Propionate	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Jul 19, 2022	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 18, 2021	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 23, 2020	Supplement 2Labeling · Standard review	Approved	Label Letter
Apr 19, 2019	Supplement 1Labeling · Standard review	Approved	Label
May 24, 2018	Original applicationTYPE 3/4 · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 210566
Drugs@FDA: Overview at FDA
Company: Mayne Pharma

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