Femring

Treats Moderate. NDA 21367, held by Millicent Mfg Pr. Estradiol Acetate.

As of Nov 14, 2026, NDA 21367 (Femring), held by Millicent Mfg Pr, was first approved by FDA on Mar 20, 2003, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 20, 2003
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Femring is an estrogen indicated for:

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Mar 20, 2003	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


FemringEQ 0.05MG BASE/24HR · insert, extended release;vaginal	Estradiol Acetate	RxReference drug
FemringEQ 0.1MG BASE/24HR · insert, extended release;vaginal	Estradiol Acetate	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 21Labeling · Standard review	Approved	Label Letter
Aug 18, 2023	Supplement 20Labeling · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 16Labeling · Standard review	Approved	Label Letter
Aug 8, 2017	Supplement 14Labeling · Standard review	Approved	Letter Label
Aug 8, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label
May 29, 2014	Supplement 13Labeling · Standard review	Approved	Letter Label
May 20, 2009	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 14, 2007	Supplement 7Labeling · Standard review	Approved	Letter Label
Aug 16, 2005	Supplement 5Labeling · Standard review	Approved	Label Letter
Mar 11, 2005	Supplement 2Labeling · Standard review	Approved	Letter Label
Mar 20, 2003	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21367
Drugs@FDA: Overview at FDA
Company: Millicent Mfg PR

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