Provera

NDA 11839, held by Pfizer. Medroxyprogesterone Acetate.

As of Nov 13, 2026, NDA 11839 (Provera), held by Pfizer, was first approved by FDA on Jun 18, 1959, with 23 approved supplements and 0 published complete response letters.

First approved: Jun 18, 1959
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Aug 4, 1998	Supplement 68Efficacy (new indication or use) · Standard review	Approved	Letter Review
Jul 23, 1979	Supplement 39Efficacy (new indication or use)	Approved	None posted
Jun 6, 1979	Supplement 35Efficacy (new indication or use)	Approved	None posted
Jun 18, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Provera2.5MG · tablet;oral	Medroxyprogesterone Acetate	RxReference drug
Provera5MG · tablet;oral	Medroxyprogesterone Acetate	RxReference drug
Provera10MG · tablet;oral	Medroxyprogesterone Acetate	RxReference drug

All 24 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 83Labeling · Standard review	Approved	Label Letter
Sep 18, 2023	Supplement 78Manufacturing	Approved	Label Letter
Dec 1, 2016	Supplement 77Manufacturing · Standard review	Approved	None posted
May 7, 2015	Supplement 80Labeling · Standard review	Approved	Letter Label
May 7, 2015	Supplement 79Labeling · Standard review	Approved	Letter Label
Sep 28, 2007	Supplement 71Labeling · Standard review	Approved	Label Letter
Aug 4, 1998	Supplement 68Efficacy (new indication or use) · Standard review	Approved	Letter Review
Mar 31, 1998	Supplement 67Labeling · Standard review	Approved	None posted
Nov 28, 1995	Supplement 66Manufacturing · Standard review	Approved	None posted
Jun 23, 1993	Supplement 63Manufacturing · Standard review	Approved	None posted
Jun 23, 1993	Supplement 61Manufacturing · Standard review	Approved	None posted
Apr 30, 1993	Supplement 62Labeling · Standard review	Approved	None posted
Jun 19, 1992	Supplement 59Manufacturing · Standard review	Approved	None posted
Dec 18, 1991	Supplement 58Labeling	Approved	None posted
Nov 19, 1991	Supplement 60Labeling	Approved	None posted
Oct 6, 1989	Supplement 53Manufacturing · Standard review	Approved	None posted
Jun 3, 1988	Supplement 52Manufacturing · Standard review	Approved	None posted
Oct 26, 1987	Supplement 50Labeling	Approved	None posted
Nov 1, 1985	Supplement 46Manufacturing · Standard review	Approved	None posted
Jul 23, 1979	Supplement 39Efficacy (new indication or use)	Approved	None posted
Jun 6, 1979	Supplement 35Efficacy (new indication or use)	Approved	None posted
Oct 21, 1975	Supplement 29REMS · Standard review	Approved	None posted
Oct 4, 1973	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 18, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11839
Drugs@FDA: Overview at FDA
Company: Pfizer

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