Estradiol

Treats moderate to severe vasomotor symptoms associated with the menopause. ANDA 40197, held by Barr Labs Inc. Estradiol.

As of Nov 14, 2026, ANDA 40197 (Estradiol), held by Barr Labs Inc, was first approved by FDA on Oct 22, 1997, with 12 approved supplements and 0 published complete response letters.

First approved: Oct 22, 1997
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Estradiol tablets are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Prevention of osteoporosis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Oct 22, 1997	Original application	Approved	Review

Products

3 strengths and forms


Estradiol0.5MG · tablet;oral	Estradiol	Rx
Estradiol1MG · tablet;oral	Estradiol	Rx
Estradiol2MG · tablet;oral	Estradiol	Rx

All 13 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Aug 24, 2018	Supplement 27Labeling · Standard review	Approved	None posted
May 1, 2006	Supplement 15Labeling	Approved	None posted
Jan 2, 2002	Supplement 9Manufacturing	Approved	None posted
Jun 22, 2001	Supplement 10Manufacturing	Approved	None posted
Dec 21, 1999	Supplement 7Manufacturing	Approved	None posted
Sep 24, 1999	Supplement 8Labeling	Approved	None posted
May 20, 1999	Supplement 6Manufacturing	Approved	None posted
May 7, 1999	Supplement 5Labeling	Approved	None posted
May 7, 1999	Supplement 4Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 2Manufacturing	Approved	None posted
Apr 7, 1998	Supplement 1Manufacturing	Approved	None posted
Oct 22, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 40197
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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