Premarin

Treats abnormal uterine bleeding due to hormonal imbalance in the absence of organic…. NDA 10402, held by Wyeth Pharms. Estrogens, Conjugated.

As of Nov 14, 2026, NDA 10402 (Premarin), held by Wyeth Pharms, was first approved by FDA on Dec 18, 1956, with 23 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1956
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Premarin Intravenous (conjugated estrogens, USP) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology. Premarin Intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Dec 18, 1956	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Premarin25MG/VIAL · injectable;injection	Estrogens, Conjugated	RxReference drug

All 24 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 73Labeling · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 68Labeling · Standard review	Approved	Letter Label
Apr 11, 2012	Supplement 63Labeling	Approved	Label Letter
Mar 3, 2008	Supplement 55Labeling · Standard review	Approved	Label Letter
Jul 26, 2006	Supplement 50Labeling · Standard review	Approved	Letter Label
Jun 1, 2006	Supplement 51Manufacturing · Standard review	Approved	Letter
Aug 30, 2005	Supplement 48Labeling · Standard review	Approved	Letter Label
Jan 14, 2005	Supplement 47Labeling · Standard review	Approved	Letter Label
Apr 20, 2004	Supplement 46Labeling · Standard review	Approved	Letter Label
Oct 17, 2002	Supplement 42Manufacturing · Standard review	Approved	None posted
Oct 9, 2002	Supplement 43Manufacturing · Standard review	Approved	None posted
May 29, 1998	Supplement 35Labeling · Standard review	Approved	None posted
Dec 14, 1995	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 6, 1995	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 12, 1993	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 24, 1993	Supplement 32Labeling · Standard review	Approved	None posted
Nov 27, 1989	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 26, 1989	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 11, 1989	Supplement 24Labeling	Approved	None posted
Mar 2, 1989	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 28, 1988	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 7, 1986	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 29, 1985	Supplement 23Labeling	Approved	None posted
Dec 18, 1956	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 10402
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