Desogen

NDA 20071, held by Organon USA Inc. Desogestrel; Ethinyl Estradiol.

As of Nov 13, 2026, NDA 20071 (Desogen), held by Organon USA Inc, was first approved by FDA on Dec 10, 1992, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1992
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 10, 1992	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Desogen0.15MG;0.03MG · tablet;oral-21	Desogestrel; Ethinyl Estradiol	Discontinued
Desogen0.15MG;0.03MG · tablet;oral-28	Desogestrel; Ethinyl Estradiol	Discontinued

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 15, 2018	Supplement 23Labeling · Standard review	Approved	Label Letter
Aug 9, 2017	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 11, 2016	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 30, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 12, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 7, 2007	Supplement 17Labeling · Standard review	Approved	Letter Label
Aug 11, 2004	Supplement 14Labeling · Standard review	Approved	Letter
Mar 8, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 27, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 19, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 5, 1998	Supplement 8Labeling · Standard review	Approved	None posted
Feb 24, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 20, 1997	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 20, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 26, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Apr 28, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Apr 25, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 3, 1995	Supplement 4Labeling · Standard review	Approved	None posted
Feb 18, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 9, 1993	Supplement 1Labeling · Standard review	Approved	None posted
Dec 10, 1992	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Identifiers

Application: NDA 20071
Drugs@FDA: Overview at FDA
Company: Organon USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters