Estradiol

Treats moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. ANDA 209767, held by Encube. Estradiol.

As of Nov 14, 2026, ANDA 209767 (Estradiol), held by Encube, was first approved by FDA on Mar 5, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 5, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Estradiol Vaginal Cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 5, 2018	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estradiol0.01% · cream;vaginal	Estradiol	Rx

All 4 submissions, including labeling and manufacturing supplements


Feb 16, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Jan 29, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Aug 15, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Mar 5, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209767
Drugs@FDA: Overview at FDA
Company: Encube Ethicals

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