Estradiol

Treats Moderate. ANDA 75182, held by Mylan Technologies. Estradiol.

As of Nov 14, 2026, ANDA 75182 (Estradiol), held by Mylan Technologies, was first approved by FDA on Feb 24, 2000, with 17 approved supplements and 0 published complete response letters.

First approved: Feb 24, 2000
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Estradiol transdermal system continuous delivery (once-weekly) is indicated for: Estradiol transdermal system continuous delivery (once-weekly) 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 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 18 submissions below

Date	Submission	Status	Documents
Feb 24, 2000	Original application	Approved	Letter Review

Products

6 strengths and forms


Estradiol0.1MG/24HR · film, extended release;transdermal	Estradiol	Rx
Estradiol0.075MG/24HR · film, extended release;transdermal	Estradiol	Rx
Estradiol0.025MG/24HR · film, extended release;transdermal	Estradiol	Rx
Estradiol0.0375MG/24HR · film, extended release;transdermal	Estradiol	Rx
Estradiol0.06MG/24HR · film, extended release;transdermal	Estradiol	Rx
Estradiol0.05MG/24HR · film, extended release;transdermal	Estradiol	Rx

All 18 submissions, including labeling and manufacturing supplements


Jun 8, 2026	Supplement 30Labeling · Standard review	Approved	None posted
Jun 8, 2026	Supplement 34Labeling · Standard review	Approved	None posted
Jun 8, 2026	Supplement 38Labeling · Standard review	Approved	None posted
Dec 21, 2014	Supplement 28Labeling · Standard review	Approved	None posted
Jul 9, 2009	Supplement 23Labeling	Approved	None posted
Jul 20, 2006	Supplement 15Manufacturing	Approved	Letter
Jul 20, 2006	Supplement 16Labeling	Approved	Letter
Oct 6, 2005	Supplement 14Labeling	Approved	None posted
Jan 26, 2005	Supplement 6	Approved	None posted
Jan 26, 2005	Supplement 8Labeling	Approved	None posted
Jan 26, 2005	Supplement 9	Approved	None posted
Jan 21, 2005	Supplement 13Labeling	Approved	None posted
Jan 6, 2005	Supplement 11Labeling	Approved	None posted
Dec 23, 2002	Supplement 3Manufacturing	Approved	None posted
Dec 23, 2002	Supplement 4Manufacturing	Approved	None posted
Oct 25, 2001	Supplement 2Labeling	Approved	None posted
Nov 20, 2000	Supplement 1Manufacturing	Approved	None posted
Feb 24, 2000	Original application	Approved	Letter Review

Identifiers

Application: ANDA 75182
Drugs@FDA: Overview at FDA
Company: Mylan Technologies

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