Nuvaring

NDA 21187, held by Organon USA Organon. Ethinyl Estradiol; Etonogestrel.

As of Nov 14, 2026, NDA 21187 (Nuvaring), held by Organon USA Organon, was first approved by FDA on Oct 3, 2001, with 26 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2001
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FOR VAGINAL USE ONLY NuvaRing is indicated for use by females of reproductive age to prevent pregnancy. NuvaRing is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Sep 30, 2016	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 4, 2013	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Review Summary Review Letter Label
Jul 29, 2005	Supplement 12Efficacy (new indication or use)	Approved	Letter Label
Oct 3, 2001	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nuvaring0.015MG/24HR;0.12MG/24HR · ring;vaginal	Ethinyl Estradiol; Etonogestrel	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


May 31, 2024	Supplement 41Labeling · Standard review	Approved	Label Letter
Apr 29, 2022	Supplement 40Labeling · Standard review	Approved	Letter Label
May 8, 2019	Supplement 37Labeling · Standard review	Approved	Label Letter
Dec 4, 2018	Supplement 36Labeling · Standard review	Approved	Letter Label
Dec 4, 2018	Supplement 35Labeling · Standard review	Approved	Letter Label
Feb 12, 2018	Supplement 31Labeling · Standard review	Approved	Label Letter
Dec 4, 2017	Supplement 34Labeling · Standard review	Approved	Review
Aug 9, 2017	Supplement 32Labeling · Standard review	Approved	Letter Label
May 30, 2017	Supplement 28Labeling · Standard review	Approved	Letter Label
Sep 30, 2016	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 19, 2016	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 31, 2014	Supplement 25Labeling · Standard review	Approved	Label Letter
Jun 18, 2014	Supplement 24Labeling · Standard review	Approved	Label Letter
Oct 4, 2013	Supplement 22Labeling · Standard review	Approved	Review Summary Review Letter Label
Oct 4, 2013	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Review Summary Review Letter Label
Jul 19, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 29, 2008	Supplement 18Labeling · Standard review	Approved	Letter
Oct 2, 2007	Supplement 17Labeling · Standard review	Approved	Label Letter
Dec 12, 2006	Supplement 16Manufacturing	Approved	None posted
Jul 29, 2005	Supplement 12Efficacy (new indication or use)	Approved	Letter Label
Mar 2, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Feb 4, 2004	Supplement 7Labeling · Standard review	Approved	Letter
Nov 5, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
May 29, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 27, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 5, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 3, 2001	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 21187
Drugs@FDA: Overview at FDA
Company: Organon USA Organon

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