Estradiol, Vivelle-Dot

Treats moderate to severe vasomotor symptoms due to menopause. NDA 20538, held by Sandoz. Estradiol.

As of Nov 13, 2026, NDA 20538 (Estradiol, Vivelle-Dot), held by Sandoz, was first approved by FDA on Jul 31, 1996, with 30 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1996
Review: Standard
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VIVELLE-DOT is indicated for: VIVELLE-DOT 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 Limitations of Use When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products.
Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure
Prevention of postmenopausal osteoporosis Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


May 3, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
May 3, 2002	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 31, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

9 strengths and forms


Estradiol0.0375MG/24HR · film, extended release; transdermal	Estradiol	Discontinued
Estradiol0.075MG/24HR · film, extended release; transdermal	Estradiol	Discontinued
Estradiol0.05MG/24HR · film, extended release; transdermal	Estradiol	Discontinued
Estradiol0.1MG/24HR · film, extended release; transdermal	Estradiol	Discontinued
Vivelle-Dot0.0375MG/24HR · system;transdermal	Estradiol	RxReference drug
Vivelle-Dot0.05MG/24HR · system;transdermal	Estradiol	RxReference drug
Vivelle-Dot0.075MG/24HR · system;transdermal	Estradiol	RxReference drug
Vivelle-Dot0.1MG/24HR · system;transdermal	Estradiol	RxReference drug
Vivelle-Dot0.025MG/24HR · system;transdermal	Estradiol	RxReference drug

All 31 submissions, including labeling and manufacturing supplements


Oct 30, 2026	Supplement 47Labeling · Standard review	Approved	Letter Label
Feb 15, 2024	Supplement 43Labeling · Standard review	Approved	Label Letter
Oct 4, 2021	Supplement 39Labeling · Standard review	Approved	Label Letter
Oct 4, 2021	Supplement 37Labeling · Standard review	Approved	Label Letter
Sep 1, 2021	Supplement 40Labeling · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 35Labeling · Standard review	Approved	Label
Sep 1, 2015	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 31, 2014	Supplement 32Labeling · Standard review	Approved	Letter Label
May 20, 2013	Supplement 30Labeling	Approved	Label Letter
May 20, 2013	Supplement 29Labeling	Approved	Letter Label
May 20, 2013	Supplement 28Labeling	Approved	Letter Label
Apr 24, 2013	Supplement 31Manufacturing · Standard review	Approved	None posted
Aug 6, 2004	Supplement 24Labeling · Standard review	Approved	Label Letter
Jan 28, 2004	Supplement 19Labeling · Standard review	Approved	Label Letter
May 3, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
May 3, 2002	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 3, 2002	Supplement 12Labeling · Standard review	Approved	Letter Label
Mar 28, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 22, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 9, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 29, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 29, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 30, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 26, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Jan 8, 1999	Supplement 6Manufacturing · Standard review	Approved	Letter Label Review
Sep 26, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 25, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 23, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 15, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 15, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 31, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20538
Drugs@FDA: Overview at FDA
Company: Sandoz

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