NDA 21180, held by Janssen Pharms. Ethinyl Estradiol; Norelgestromin.
As of Nov 15, 2026, NDA 21180 (Ortho Evra), held by Janssen Pharms, was first approved by FDA on Nov 20, 2001, with 29 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2001 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ortho Evra0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · film, extended release;transdermal | Ethinyl Estradiol; Norelgestromin | DiscontinuedReference drug |
| Aug 9, 2017 | Supplement 48Labeling · Standard review | Approved | |
| Oct 22, 2015 | Supplement 47Labeling · Standard review | Approved | |
| Apr 11, 2014 | Supplement 46Labeling · Standard review | Approved | |
| Jul 1, 2013 | Supplement 44Labeling · Standard review | Approved | |
| Apr 12, 2013 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2013 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Aug 22, 2012 | Supplement 43Labeling | Approved | |
| Dec 28, 2011 | Supplement 40Labeling | Approved | |
| Jul 26, 2011 | Supplement 38Labeling | Approved | |
| Mar 23, 2011 | Supplement 39Labeling | Approved | |
| Apr 13, 2010 | Supplement 35Labeling | Approved | |
| Dec 1, 2009 | Supplement 34Labeling · Standard review | Approved | |
| Sep 11, 2009 | Supplement 33Labeling · Standard review | Approved | |
| Jul 29, 2009 | Supplement 29Labeling · Standard review | Approved | |
| Oct 30, 2008 | Supplement 31Labeling · Standard review | Approved | |
| Oct 30, 2008 | Supplement 30Labeling · Standard review | Approved | |
| Oct 30, 2008 | Supplement 28Labeling · Standard review | Approved | |
| Jan 18, 2008 | Supplement 26Labeling · Standard review | Approved | |
| Sep 20, 2006 | Supplement 22Labeling · Standard review | Approved | |
| May 17, 2006 | Supplement 20Labeling · Standard review | Approved | |
| Nov 10, 2005 | Supplement 19Labeling · Standard review | Approved | |
| May 6, 2005 | Supplement 15Labeling · Standard review | Approved | |
| Nov 24, 2004 | Supplement 14Manufacturing · Standard review | Approved | |
| Feb 4, 2004 | Supplement 8Labeling · Standard review | Approved | |
| Nov 14, 2002 | Supplement 3Manufacturing · Standard review | Approved | |
| Oct 2, 2002 | Supplement 4Manufacturing · Standard review | Approved | |
| Aug 9, 2002 | Supplement 2Manufacturing · Standard review | Approved | |
| Jun 18, 2002 | Supplement 5Manufacturing · Standard review | Approved | |
| Mar 4, 2002 | Supplement 1Manufacturing · Standard review | Approved | |
| Nov 20, 2001 | Original applicationNew molecular entity, new combination · Standard review | Approved |
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
