Delestrogen

Treats moderate to severe vasomotor symptoms associated with the menopause. NDA 9402, held by Ph Health. Estradiol Valerate.

As of Nov 13, 2026, NDA 9402 (Delestrogen), held by Ph Health, was first approved by FDA on Jul 15, 1954, with 27 approved supplements and 0 published complete response letters.

First approved: Jul 15, 1954
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. 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. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Jul 15, 1954	Original application	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Delestrogen10MG/ML · injectable;injection	Estradiol Valerate	RxReference drug
Delestrogen40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Estradiol Valerate	DiscontinuedReference drug
Delestrogen20MG/ML · injectable;injection	Estradiol Valerate	RxReference drug

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 15, 2024	Supplement 63Labeling · Standard review	Approved	Label Letter
Feb 16, 2022	Supplement 60Labeling · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 52Labeling · Standard review	Approved	Letter Label
Mar 10, 2016	Supplement 49Manufacturing	Approved	None posted
Oct 20, 2015	Supplement 47Manufacturing	Approved	None posted
Aug 11, 2015	Supplement 46Manufacturing	Approved	None posted
Oct 11, 2007	Supplement 41Manufacturing	Approved	Letter
Jul 26, 2004	Supplement 40Labeling · Standard review	Approved	Letter Label
Dec 12, 2003	Supplement 37Labeling · Standard review	Approved	Label Letter
Dec 12, 2003	Supplement 39Labeling · Standard review	Approved	Letter Label
Jul 17, 2002	Supplement 38Manufacturing	Approved	None posted
Jun 17, 1998	Supplement 36Labeling · Standard review	Approved	None posted
Jan 12, 1990	Supplement 35Labeling	Approved	None posted
May 5, 1989	Supplement 34Manufacturing	Approved	None posted
Mar 2, 1989	Supplement 29Labeling	Approved	None posted
Mar 2, 1989	Supplement 33Labeling	Approved	None posted
Dec 28, 1987	Supplement 31Labeling	Approved	None posted
Sep 11, 1987	Supplement 30Manufacturing	Approved	None posted
May 5, 1986	Supplement 27Manufacturing	Approved	None posted
Jul 31, 1985	Supplement 22Manufacturing	Approved	None posted
Jan 15, 1985	Supplement 26Labeling	Approved	None posted
Nov 26, 1984	Supplement 25Labeling	Approved	None posted
Nov 16, 1984	Supplement 24Labeling	Approved	None posted
Jun 1, 1984	Supplement 23Manufacturing	Approved	None posted
Mar 19, 1984	Supplement 21Labeling	Approved	None posted
Jul 18, 1983	Supplement 20Manufacturing	Approved	None posted
Sep 7, 1982	Supplement 19Manufacturing	Approved	None posted
Jul 15, 1954	Original application	Approved	None posted

Identifiers

Application: NDA 9402
Drugs@FDA: Overview at FDA
Company: PH Health

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