Estradiol

Treats atrophic vaginitis due to menopause. ANDA 206388, held by Teva Pharms USA. Estradiol.

As of Nov 14, 2026, ANDA 206388 (Estradiol), held by Teva Pharms USA, was first approved by FDA on Jul 21, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 21, 2017
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Estradiol vaginal inserts are an estrogen indicated for the treatment of atrophic vaginitis due to menopause 1.1 Treatment of Atrophic Vaginitis due to Menopause

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
Jul 21, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estradiol10MCG · tablet;vaginal	Estradiol	Rx

All 5 submissions, including labeling and manufacturing supplements


Aug 4, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Aug 4, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Feb 17, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Feb 17, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Jul 21, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206388
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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