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Premarin

Treats Moderate. NDA 4782, held by Wyeth Pharms. Estrogens, Conjugated.

As of Nov 13, 2026, NDA 4782 (Premarin), held by Wyeth Pharms, was first approved by FDA on May 8, 1942, with 75 approved supplements and 0 published complete response letters.

First approved: May 8, 1942
Review: Standard
Supplements approved: 75
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PREMARIN is a mixture of estrogens indicated for:

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
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 Postmenopausal Osteoporosis 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 76 submissions below


Apr 24, 2003	Supplement 115Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 8, 1998	Supplement 93Efficacy (new indication or use)	Approved	Letter Review
May 8, 1942	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

6 strengths and forms


Premarin1.25MG · tablet;oral	Estrogens, Conjugated	RxReference drug
Premarin2.5MG · tablet;oral	Estrogens, Conjugated	Discontinued
Premarin0.3MG · tablet;oral	Estrogens, Conjugated	RxReference drug
Premarin0.625MG · tablet;oral	Estrogens, Conjugated	RxReference drug
Premarin0.9MG · tablet;oral	Estrogens, Conjugated	RxReference drug
Premarin0.45MG · tablet;oral	Estrogens, Conjugated	RxReference drug

All 76 submissions, including labeling and manufacturing supplements


Apr 22, 2025	Supplement 179Labeling · Standard review	Approved	Letter Label
Feb 15, 2024	Supplement 181Labeling · Standard review	Approved	Label Letter
Nov 7, 2017	Supplement 176Labeling · Standard review	Approved	Label Letter
Sep 1, 2015	Supplement 173Manufacturing · Standard review	Approved	None posted
Jun 9, 2015	Supplement 172Manufacturing · Standard review	Approved	None posted
Dec 3, 2014	Supplement 171Labeling · Standard review	Approved	Label Letter
Apr 11, 2014	Supplement 163Manufacturing · Standard review	Approved	None posted
Oct 28, 2011	Supplement 162Labeling	Approved	Label Letter
Oct 28, 2011	Supplement 164Labeling	Approved	Label Letter
Oct 28, 2011	Supplement 167Labeling	Approved	Label Letter
Mar 3, 2008	Supplement 155Labeling · Standard review	Approved	Letter Label
Sep 5, 2006	Supplement 147Labeling · Standard review	Approved	Letter Label
Apr 24, 2006	Supplement 146Labeling · Standard review	Approved	Letter Label
Nov 1, 2005	Supplement 142Manufacturing · Standard review	Approved	Letter Label
Aug 1, 2005	Supplement 141Manufacturing · Standard review	Approved	Letter Label
Apr 7, 2005	Supplement 138Labeling · Standard review	Approved	Letter Label
Apr 7, 2005	Supplement 139Labeling · Standard review	Approved	Letter Label
Aug 26, 2004	Supplement 137Manufacturing · Standard review	Approved	Letter Label
Apr 20, 2004	Supplement 133Labeling · Standard review	Approved	Label Letter
Apr 20, 2004	Supplement 136Labeling · Standard review	Approved	Label Letter
Jul 16, 2003	Supplement 125Labeling · Standard review	Approved	Letter
Apr 24, 2003	Supplement 115Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Apr 24, 2003	Supplement 130Labeling · Standard review	Approved	Review Letter Label
Jan 7, 2003	Supplement 129Labeling · Standard review	Approved	Letter Label
Dec 20, 2002	Supplement 126Manufacturing · Standard review	Approved	None posted
Nov 27, 2002	Supplement 128Labeling · Standard review	Approved	Letter Label
Aug 21, 2002	Supplement 124Manufacturing · Standard review	Approved	None posted
Dec 3, 2001	Supplement 121Manufacturing · Standard review	Approved	None posted
Aug 6, 2001	Supplement 120Manufacturing · Standard review	Approved	None posted
Apr 24, 2001	Supplement 116Manufacturing · Standard review	Approved	None posted
Jul 5, 2000	Supplement 113Manufacturing · Standard review	Approved	None posted
Jun 8, 1999	Supplement 109Labeling · Standard review	Approved	None posted
Apr 26, 1999	Supplement 86Manufacturing · Standard review	Approved	None posted
Oct 29, 1998	Supplement 108Manufacturing · Standard review	Approved	None posted
Sep 8, 1998	Supplement 93Efficacy (new indication or use)	Approved	Letter Review
May 6, 1998	Supplement 104Labeling · Standard review	Approved	None posted
May 6, 1998	Supplement 96Labeling · Standard review	Approved	None posted
Feb 27, 1998	Supplement 101Manufacturing · Standard review	Approved	None posted
Jun 28, 1996	Supplement 103Manufacturing · Standard review	Approved	None posted
Jun 27, 1996	Supplement 102Manufacturing · Standard review	Approved	None posted
Dec 14, 1995	Supplement 100Manufacturing · Standard review	Approved	None posted
Dec 13, 1995	Supplement 99Manufacturing · Standard review	Approved	None posted
Apr 11, 1995	Supplement 98Manufacturing · Standard review	Approved	None posted
Feb 6, 1995	Supplement 95Manufacturing · Standard review	Approved	None posted
Nov 9, 1994	Supplement 94Manufacturing · Standard review	Approved	None posted
Dec 23, 1993	Supplement 92Labeling · Standard review	Approved	None posted
Mar 11, 1992	Supplement 87Manufacturing · Standard review	Approved	None posted
May 14, 1991	Supplement 77Manufacturing · Standard review	Approved	None posted
May 9, 1991	Supplement 78Manufacturing · Standard review	Approved	None posted
Feb 23, 1990	Supplement 83Manufacturing · Standard review	Approved	None posted
Dec 22, 1989	Supplement 81Labeling	Approved	None posted
May 19, 1989	Supplement 61Labeling	Approved	None posted
May 19, 1989	Supplement 64Labeling	Approved	None posted
May 19, 1989	Supplement 72Labeling	Approved	None posted
May 19, 1989	Supplement 75Labeling	Approved	None posted
May 19, 1989	Supplement 79Labeling	Approved	None posted
Feb 3, 1989	Supplement 74Manufacturing · Standard review	Approved	None posted
Dec 20, 1988	Supplement 73Manufacturing · Standard review	Approved	None posted
Apr 17, 1988	Supplement 71Manufacturing · Standard review	Approved	None posted
Oct 16, 1987	Supplement 68Manufacturing · Standard review	Approved	None posted
May 14, 1987	Supplement 70Manufacturing · Standard review	Approved	None posted
Dec 3, 1986	Supplement 65Manufacturing · Standard review	Approved	None posted
Sep 24, 1986	Supplement 66Manufacturing · Standard review	Approved	None posted
Jul 10, 1986	Supplement 63Manufacturing · Standard review	Approved	None posted
May 28, 1986	Supplement 57Labeling	Approved	None posted
May 12, 1986	Supplement 62Manufacturing · Standard review	Approved	None posted
Jan 7, 1986	Supplement 60Manufacturing · Standard review	Approved	None posted
Oct 25, 1985	Supplement 59Manufacturing · Standard review	Approved	None posted
Sep 30, 1985	Supplement 58Manufacturing · Standard review	Approved	None posted
May 29, 1985	Supplement 50Manufacturing · Standard review	Approved	None posted
May 29, 1985	Supplement 52Manufacturing · Standard review	Approved	None posted
Apr 29, 1985	Supplement 51Labeling	Approved	None posted
Apr 29, 1985	Supplement 53Labeling	Approved	None posted
Apr 29, 1985	Supplement 54Labeling	Approved	None posted
Jan 26, 1984	Supplement 49Manufacturing · Standard review	Approved	None posted
May 8, 1942	Original applicationNew molecular entity · Standard review	Approved	None posted

Show all 76

Identifiers

Application: NDA 4782
Drugs@FDA: Overview at FDA
Company: Wyeth 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