Estrace

Treats moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. ANDA 86069, held by Abbvie. Estradiol.

As of Nov 14, 2026, ANDA 86069 (Estrace), held by Abbvie, was first approved by FDA on Jan 31, 1984, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1984
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Estradiol vaginal cream, USP, 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 18 submissions below

Date	Submission	Status	Documents
Jan 31, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estrace0.01% · cream;vaginal	Estradiol	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 27Labeling · Standard review	Approved	None posted
Nov 30, 2022	Supplement 26Labeling · Standard review	Approved	Letter Label
Aug 15, 2018	Supplement 24Labeling · Standard review	Approved	None posted
Jun 21, 2017	Supplement 23Labeling · Standard review	Approved	None posted
Aug 17, 2005	Supplement 18Labeling	Approved	Label
Mar 27, 2001	Supplement 17Manufacturing	Approved	Review
Aug 11, 2000	Supplement 15Manufacturing	Approved	None posted
Aug 11, 2000	Supplement 16Labeling	Approved	None posted
Aug 3, 1998	Supplement 12Labeling	Approved	None posted
Sep 9, 1997	Supplement 11Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 10Labeling	Approved	None posted
Jan 14, 1994	Supplement 9Manufacturing	Approved	None posted
Sep 23, 1992	Supplement 8Labeling	Approved	None posted
Mar 11, 1992	Supplement 5Labeling	Approved	None posted
Jun 7, 1991	Supplement 7Labeling	Approved	None posted
Oct 16, 1987	Supplement 3Manufacturing	Approved	None posted
Jul 17, 1986	Supplement 2Manufacturing	Approved	None posted
Jan 31, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 86069
Drugs@FDA: Overview at FDA
Company: AbbVie

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