Estrogel

Treats moderate to severe vasomotor symptoms due to menopause. NDA 21166, held by Ascend Theraps US. Estradiol.

As of Nov 14, 2026, NDA 21166 (Estrogel), held by Ascend Theraps US, was first approved by FDA on Feb 9, 2004, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 9, 2004
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EstroGel 0.06% is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause. Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Feb 9, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Estrogel0.06% · gel;topical	Estradiol	Discontinued
Estrogel0.06% (1.25GM/ACTIVATION) · gel, metered;transdermal	Estradiol	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


May 19, 2026	Supplement 20Manufacturing	Approved	Label Letter
Feb 15, 2024	Supplement 19Labeling · Standard review	Approved	Label Letter
Aug 1, 2023	Supplement 18Labeling · Standard review	Approved	Label Letter
Nov 30, 2021	Supplement 17Labeling · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 15Labeling · Standard review	Approved	Label
Jun 11, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 25, 2014	Supplement 10Labeling	Approved	Label Letter
Nov 14, 2012	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 25, 2008	Supplement 7Labeling · Standard review	Approved	Label Letter
Jul 25, 2007	Supplement 5Labeling · Standard review	Approved	Letter Label
Oct 4, 2006	Supplement 4Manufacturing	Approved	None posted
Sep 13, 2004	Supplement 1Labeling · Standard review	Approved	Letter
Feb 9, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: EstroGelAug 16, 2018

Identifiers

Application: NDA 21166
Drugs@FDA: Overview at FDA
Company: Ascend Therapeutics US, LLC

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