Estradiol

Treats atrophic vaginitis due to menopause. ANDA 210264, held by Glenmark Pharms Ltd. Estradiol.

As of Nov 14, 2026, ANDA 210264 (Estradiol), held by Glenmark Pharms Ltd, was first approved by FDA on Sep 14, 2018, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 14, 2018
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
Sep 14, 2018	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 30, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Aug 30, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Aug 30, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Feb 17, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Sep 14, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210264
Drugs@FDA: Overview at FDA
Company: Glenmark 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