Implanon, Nexplanon

Prevents pregnancy. NDA 21529, held by Organon. Etonogestrel.

As of Nov 14, 2026, NDA 21529 (Implanon, Nexplanon), held by Organon, was first approved by FDA on Jul 17, 2006, with 20 approved supplements and 0 published complete response letters.

First approved: Jul 17, 2006
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NEXPLANON is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below


Jan 16, 2026	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 13, 2011	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jul 17, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Implanon68MG/IMPLANT · implant;implantation	Etonogestrel	Discontinued
Nexplanon68MG/IMPLANT · implant;implantation	Etonogestrel	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Aug 17, 2026	Supplement 30REMS	Approved	Letter
May 28, 2026	Supplement 28Labeling · Standard review	Approved	Label Letter
Jan 16, 2026	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 29, 2023	Supplement 21Labeling · Standard review	Approved	Label Letter
Sep 29, 2023	Supplement 22Labeling · Standard review	Approved	Letter Label
Sep 29, 2023	Supplement 24Labeling · Standard review	Approved	Label Letter
Sep 24, 2020	Supplement 19Labeling · Standard review	Approved	Letter
Sep 24, 2020	Supplement 20Labeling · Standard review	Approved	Letter Label
Apr 22, 2019	Supplement 18Labeling · Standard review	Approved	Review Label Letter
May 19, 2017	Supplement 15Labeling · Standard review	Approved	Label Letter
Mar 14, 2016	Supplement 13Labeling · Standard review	Approved	Letter Label
Sep 3, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 19, 2015	Supplement 11Labeling · Standard review	Approved	Review Letter Label
Jul 3, 2014	Supplement 8Labeling · Standard review	Approved	Review Label
Sep 27, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 12, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 1, 2012	Supplement 6Labeling · Standard review	Approved	Label Letter
May 13, 2011	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 19, 2009	Supplement 4Labeling · Standard review	Approved	Review Letter Label
Jan 18, 2007	Supplement 1Labeling · Standard review	Approved	Review Letter
Jul 17, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21529
Drugs@FDA: Overview at FDA
Company: 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