Ortho Cyclen-21, Ortho Cyclen-28

NDA 19653, held by Janssen Pharms. Ethinyl Estradiol; Norgestimate.

As of Nov 13, 2026, NDA 19653 (Ortho Cyclen-21, Ortho Cyclen-28), held by Janssen Pharms, was first approved by FDA on Dec 29, 1989, with 37 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1989
Review: Standard
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below

Date	Submission	Status	Documents
Dec 29, 1989	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ortho Cyclen-210.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-21	Ethinyl Estradiol; Norgestimate	Discontinued
Ortho Cyclen-280.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-28	Ethinyl Estradiol; Norgestimate	DiscontinuedReference drug

All 38 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 9, 2017	Supplement 58Labeling · Standard review	Approved	Letter Label
Jun 22, 2016	Supplement 57Manufacturing · Standard review	Approved	None posted
May 1, 2015	Supplement 56Labeling · Standard review	Approved	Letter Label
Oct 3, 2013	Supplement 46Labeling · Standard review	Approved	Label Letter
Oct 2, 2013	Supplement 54Labeling · Standard review	Approved	Letter
Oct 2, 2013	Supplement 51Labeling · Standard review	Approved	Letter
Oct 2, 2013	Supplement 49Labeling · Standard review	Approved	Letter
Jun 18, 2012	Supplement 48Labeling · Standard review	Approved	Label Letter
May 30, 2008	Supplement 45Manufacturing	Approved	Letter
May 3, 2007	Supplement 37Labeling · Standard review	Approved	Letter Label
Jan 3, 2003	Supplement 35	Approved	Review
Sep 6, 2002	Supplement 33Manufacturing · Standard review	Approved	Review
Jun 3, 2002	Supplement 32Manufacturing · Standard review	Approved	Review
Jan 16, 2002	Supplement 31Manufacturing · Standard review	Approved	Review
Jul 9, 2001	Supplement 30Manufacturing · Standard review	Approved	Review
Jan 16, 2001	Supplement 27Labeling · Standard review	Approved	Review
Jun 5, 2000	Supplement 25Labeling · Standard review	Approved	None posted
Jan 5, 2000	Supplement 24Manufacturing · Standard review	Approved	Review
Nov 22, 1999	Supplement 22Labeling · Standard review	Approved	Review
Nov 2, 1999	Supplement 21Manufacturing · Standard review	Approved	Review
Oct 20, 1999	Supplement 20Manufacturing · Standard review	Approved	Review
Sep 30, 1999	Supplement 23Manufacturing · Standard review	Approved	Review
Apr 20, 1998	Supplement 17Labeling · Standard review	Approved	Review
Aug 21, 1996	Supplement 18Manufacturing · Standard review	Approved	Review
Aug 2, 1996	Supplement 16Manufacturing · Standard review	Approved	Review
Feb 14, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 29, 1996	Supplement 12Labeling · Standard review	Approved	None posted
Nov 30, 1995	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 21, 1995	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 16, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 28, 1994	Supplement 11Labeling · Standard review	Approved	None posted
Nov 4, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 30, 1993	Supplement 1Labeling	Approved	None posted
Oct 1, 1992	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 24, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 17, 1991	Supplement 3Labeling	Approved	None posted
May 23, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 29, 1989	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Identifiers

Application: NDA 19653
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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