Prempro, Premphase 14/14

Treats Moderate. NDA 20527, held by Wyeth Pharms. Estrogens, Conjugated; Medroxyprogesterone Acetate.

As of Nov 13, 2026, NDA 20527 (Prempro, Premphase 14/14), held by Wyeth Pharms, was first approved by FDA on Nov 17, 1995, with 39 approved supplements and 0 published complete response letters.

First approved: Nov 17, 1995
Review: Standard
Supplements approved: 39
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PREMPRO/PREMPHASE is an estrogen plus progestin indicated in a woman with a uterus for:

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
Prevention of Postmenopausal Osteoporosis 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause 1.3 Prevention of Postmenopausal Osteoporosis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 40 submissions below


Jun 4, 2003	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 12, 2003	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jan 9, 1998	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Review
Nov 17, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

5 strengths and forms


Prempro0.625MG;2.5MG · tablet;oral-28	Estrogens, Conjugated; Medroxyprogesterone Acetate	RxReference drug
Premphase 14/140.625MG,0.625MG;N/A,5MG · tablet;oral-28	Estrogens, Conjugated; Medroxyprogesterone Acetate	RxReference drug
Prempro0.625MG;5MG · tablet;oral-28	Estrogens, Conjugated; Medroxyprogesterone Acetate	RxReference drug
Prempro0.45MG;1.5MG · tablet;oral-28	Estrogens, Conjugated; Medroxyprogesterone Acetate	RxReference drug
Prempro0.3MG;1.5MG · tablet;oral-28	Estrogens, Conjugated; Medroxyprogesterone Acetate	RxReference drug

All 40 submissions, including labeling and manufacturing supplements


Apr 22, 2025	Supplement 67Labeling · Standard review	Approved	Label
Feb 15, 2024	Supplement 68Labeling · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 65Labeling · Standard review	Approved	Letter Label
May 4, 2016	Supplement 63Manufacturing · Standard review	Approved	None posted
Feb 25, 2016	Supplement 61Manufacturing · Standard review	Approved	None posted
Aug 31, 2015	Supplement 62Labeling · Standard review	Approved	Letter Label
Jul 1, 2014	Supplement 59Manufacturing · Standard review	Approved	None posted
Feb 2, 2012	Supplement 56Labeling	Approved	Letter Label
Feb 2, 2012	Supplement 54Labeling	Approved	Letter Label
Feb 2, 2012	Supplement 52Manufacturing · Standard review	Approved	Letter Label
Feb 2, 2012	Supplement 51Labeling	Approved	Letter Label
Dec 30, 2009	Supplement 45Labeling · Standard review	Approved	Letter Label
May 18, 2009	Supplement 46Manufacturing · Standard review	Approved	Review Label Letter
Mar 3, 2008	Supplement 43Labeling · Standard review	Approved	Letter Label
Jul 27, 2006	Supplement 37Labeling · Standard review	Approved	Letter Label
Jun 30, 2005	Supplement 36Labeling · Standard review	Approved	Letter Label
Apr 20, 2004	Supplement 35Labeling · Standard review	Approved	Label Letter
Apr 20, 2004	Supplement 34Labeling · Standard review	Approved	Letter Label
Jun 4, 2003	Supplement 31Labeling · Standard review	Approved	Review Letter Label
Jun 4, 2003	Supplement 26Labeling · Standard review	Approved	Review Letter Label
Jun 4, 2003	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 12, 2003	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jan 7, 2003	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 27, 2002	Supplement 29Labeling · Standard review	Approved	Letter Label
Jul 10, 2002	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 11, 2002	Supplement 18Labeling · Standard review	Approved	Letter
Dec 3, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 6, 2000	Supplement 15Labeling · Standard review	Approved	None posted
Mar 18, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
May 12, 1998	Supplement 13Labeling · Standard review	Approved	Review
Mar 10, 1998	Supplement 9Labeling · Standard review	Approved	None posted
Jan 9, 1998	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Review
Aug 8, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 31, 1997	Supplement 4Labeling · Standard review	Approved	Review
Jun 30, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 24, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 18, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 28, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 27, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 17, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20527
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