Divigel

Treats moderate to severe vasomotor symptoms due to menopause. NDA 22038, held by Vertical Pharms. Estradiol.

As of Nov 14, 2026, NDA 22038 (Divigel), held by Vertical Pharms, was first approved by FDA on Jun 4, 2007, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 4, 2007
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Divigel is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Dec 12, 2019	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 17, 2018	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 4, 2007	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Label Letter

Products

5 strengths and forms


Divigel0.1% (0.25GM/PACKET) · gel;transdermal	Estradiol	RxReference drug
Divigel0.1% (0.5GM/PACKET) · gel;transdermal	Estradiol	RxReference drug
Divigel0.1% (1GM/PACKET) · gel;transdermal	Estradiol	RxReference drug
Divigel0.1% (0.75GM/PACKET) · gel;transdermal	Estradiol	RxReference drug
Divigel0.1% (1.25GM/PACKET) · gel;transdermal	Estradiol	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Feb 12, 2026	Supplement 17Labeling · Standard review	Approved	Label Letter
Apr 29, 2025	Supplement 14Labeling · Standard review	Approved	Label Letter
Feb 15, 2024	Supplement 12Labeling · Standard review	Approved	Label Letter
May 23, 2023	Supplement 10Labeling · Standard review	Approved	Letter Label
Dec 12, 2019	Supplement 5Labeling · Standard review	Approved	Letter Label
Dec 12, 2019	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 17, 2018	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 3Labeling · Standard review	Approved	Label
May 29, 2012	Supplement 2Labeling · Standard review	Approved	Label Letter
Jun 4, 2007	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 22038
Drugs@FDA: Overview at FDA
Company: Vertical Pharmaceuticals

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