Ortho Tri-Cyclen

NDA 19697, held by Janssen Pharms. Ethinyl Estradiol; Norgestimate.

As of Nov 13, 2026, NDA 19697 (Ortho Tri-Cyclen), held by Janssen Pharms, was first approved by FDA on Jul 3, 1992, with 37 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1992
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
Jul 3, 1992	Original applicationNew dosage form · Standard review	Approved	Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Statistical Review Pediatric Written Request

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ortho Tri-Cyclen0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,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Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-28	Ethinyl Estradiol; Norgestimate	DiscontinuedReference drug
Ortho Tri-Cyclen0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-21	Ethinyl Estradiol; Norgestimate	Discontinued

All 38 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 15, 2023	Supplement 57Labeling · Standard review	Approved	Label Letter
Jun 15, 2023	Supplement 56Labeling · Standard review	Approved	Label Letter
Apr 29, 2022	Supplement 58Labeling · Standard review	Approved	Letter Label
Aug 9, 2017	Supplement 54Labeling · Standard review	Approved	Letter Label
May 1, 2015	Supplement 52Labeling · Standard review	Approved	Letter Label
Oct 3, 2013	Supplement 42Labeling · Standard review	Approved	Label Letter
Oct 2, 2013	Supplement 50Labeling · Standard review	Approved	Letter
Oct 2, 2013	Supplement 47Labeling · Standard review	Approved	Letter Label
Oct 2, 2013	Supplement 45Labeling · Standard review	Approved	Letter
Jun 18, 2012	Supplement 44Labeling · Standard review	Approved	Label Letter
May 30, 2008	Supplement 41Manufacturing	Approved	Letter
May 3, 2007	Supplement 34Labeling · Standard review	Approved	Letter Label
Jan 3, 2003	Supplement 32Manufacturing · Standard review	Approved	Review
Sep 6, 2002	Supplement 30Manufacturing · Standard review	Approved	Review
Jun 3, 2002	Supplement 29Manufacturing · Standard review	Approved	Review
Jan 16, 2002	Supplement 28Manufacturing · Standard review	Approved	Review
Jul 9, 2001	Supplement 27Manufacturing · Standard review	Approved	Review
Jan 16, 2001	Supplement 24Labeling · Standard review	Approved	Review
Aug 30, 2000	Supplement 25Manufacturing · Standard review	Approved	Review
Jun 5, 2000	Supplement 22Labeling · Standard review	Approved	None posted
Jan 5, 2000	Supplement 21Manufacturing · Standard review	Approved	Review
Nov 22, 1999	Supplement 18Labeling · Standard review	Approved	Review
Nov 2, 1999	Supplement 16Manufacturing · Standard review	Approved	Review
Oct 20, 1999	Supplement 15Manufacturing · Standard review	Approved	Review
Sep 30, 1999	Supplement 19Manufacturing · Standard review	Approved	Review
Apr 20, 1998	Supplement 12Labeling · Standard review	Approved	None posted
Aug 21, 1996	Supplement 13Manufacturing · Standard review	Approved	Review
Aug 2, 1996	Supplement 11Manufacturing · Standard review	Approved	Review
Feb 14, 1996	Supplement 10Manufacturing · Standard review	Approved	Review
Feb 7, 1996	Supplement 9Manufacturing · Standard review	Approved	Review
Jan 29, 1996	Supplement 5Labeling · Standard review	Approved	Review
Nov 30, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 21, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 21, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 16, 1995	Supplement 2Manufacturing · Standard review	Approved	Review
Dec 28, 1994	Supplement 4Manufacturing · Standard review	Approved	Review
Jun 28, 1994	Supplement 3Labeling · Standard review	Approved	None posted
Jul 3, 1992	Original applicationNew dosage form · Standard review	Approved	Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Statistical Review Pediatric Written Request

Identifiers

Application: NDA 19697
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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