Estradiol

Treats moderate to severe vasomotor symptoms due to menopause. ANDA 201675, held by Mylan Technologies. Estradiol.

As of Nov 14, 2026, ANDA 201675 (Estradiol), held by Mylan Technologies, was first approved by FDA on Dec 19, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2014
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Estradiol transdermal system (twice-weekly) is indicated for: Estradiol transdermal system (twice-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 vaginal atrophy, 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 5 submissions below

Date	Submission	Status	Documents
Dec 19, 2014	Original application	Approved	None posted

Products

5 strengths and forms


Estradiol0.025MG/24HR · system;transdermal	Estradiol	Rx
Estradiol0.0375MG/24HR · system;transdermal	Estradiol	Rx
Estradiol0.05MG/24HR · system;transdermal	Estradiol	Rx
Estradiol0.075MG/24HR · system;transdermal	Estradiol	Rx
Estradiol0.1MG/24HR · system;transdermal	Estradiol	Rx

All 5 submissions, including labeling and manufacturing supplements


Nov 5, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Jan 8, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Aug 14, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Aug 14, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Dec 19, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 201675
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