Prometrium

Prevents endometrial hyperplasia in nonhysterectomized postmenopausal women. NDA 19781, held by Acertis Pharms. Progesterone.

As of Nov 13, 2026, NDA 19781 (Prometrium), held by Acertis Pharms, was first approved by FDA on May 14, 1998, with 16 approved supplements and 0 published complete response letters.

First approved: May 14, 1998
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE PROMETRIUM (progesterone, USP) Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
May 14, 1998	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

3 strengths and forms

Product	Active ingredient	Marketing
Prometrium100MG · capsule;oral	Progesterone	RxReference drug
Prometrium200MG · capsule;oral	Progesterone	RxReference drug
Prometrium300MG · capsule;oral	Progesterone	Discontinued

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 12, 2026	Supplement 26Labeling · Standard review	Approved	Label Letter
Feb 15, 2024	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 18, 2020	Supplement 22Manufacturing	Approved	Letter Label
Sep 30, 2014	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 13, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 19, 2013	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 1, 2011	Supplement 17Labeling	Approved	Label Letter
Jun 30, 2009	Supplement 13Labeling · Standard review	Approved	Letter Label
Dec 10, 2004	Supplement 5Labeling · Standard review	Approved	None posted
Dec 10, 2004	Supplement 6Labeling · Standard review	Approved	None posted
Mar 4, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Mar 1, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 17, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 17, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 17, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 15, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
May 14, 1998	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 19781
Drugs@FDA: Overview at FDA
Company: Acertis 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