Ortho-Novum 10/11-21, Ortho-Novum 10/11-28

NDA 18354, held by Ortho Mcneil Janssen. Ethinyl Estradiol; Norethindrone.

As of Nov 14, 2026, NDA 18354 (Ortho-Novum 10/11-21, Ortho-Novum 10/11-28), held by Ortho Mcneil Janssen, was first approved by FDA on Jan 11, 1982, with 40 approved supplements and 0 published complete response letters.

First approved: Jan 11, 1982
Review: Standard
Supplements approved: 40
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 41 submissions below

Date	Submission	Status	Documents
Jan 11, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Ortho-Novum 10/11-210.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-21	Ethinyl Estradiol; Norethindrone	DiscontinuedReference drug
Ortho-Novum 10/11-280.035MG,0.035MG;0.5MG,1MG · tablet;oral-28	Ethinyl Estradiol; Norethindrone	DiscontinuedReference drug

All 41 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 40Labeling · Standard review	Approved	None posted
Mar 13, 2009	Supplement 10Labeling	Approved	None posted
Mar 13, 2009	Supplement 1Labeling	Approved	None posted
Jun 3, 2002	Supplement 43Manufacturing · Standard review	Approved	None posted
Feb 21, 2002	Supplement 42Manufacturing · Standard review	Approved	None posted
Jul 9, 2001	Supplement 41Manufacturing · Standard review	Approved	None posted
Jan 21, 2000	Supplement 38Labeling · Standard review	Approved	None posted
Jan 5, 2000	Supplement 39Manufacturing · Standard review	Approved	None posted
Aug 27, 1999	Supplement 37Labeling · Standard review	Approved	None posted
Aug 27, 1999	Supplement 34Labeling · Standard review	Approved	None posted
Apr 28, 1998	Supplement 36Manufacturing · Standard review	Approved	None posted
Apr 13, 1998	Supplement 35Manufacturing · Standard review	Approved	None posted
Feb 24, 1997	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 29, 1997	Supplement 33Manufacturing · Standard review	Approved	None posted
May 10, 1996	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 9, 1996	Supplement 31Manufacturing · Standard review	Approved	None posted
Nov 30, 1995	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 7, 1995	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 16, 1995	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 6, 1994	Supplement 26Labeling · Standard review	Approved	None posted
Mar 7, 1994	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 4, 1993	Supplement 25Manufacturing · Standard review	Approved	None posted
May 18, 1993	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 16, 1991	Supplement 20Labeling	Approved	None posted
Mar 18, 1991	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 18, 1990	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 23, 1989	Supplement 17Labeling	Approved	None posted
Jul 19, 1989	Supplement 16Labeling	Approved	None posted
Oct 28, 1988	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 9, 1988	Supplement 13Labeling	Approved	None posted
Jun 8, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 23, 1987	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 26, 1987	Supplement 12Labeling	Approved	None posted
Oct 21, 1985	Supplement 9Labeling	Approved	None posted
Apr 5, 1985	Supplement 8Labeling	Approved	None posted
Jun 21, 1984	Supplement 7Labeling	Approved	None posted
Jan 30, 1984	Supplement 6Labeling	Approved	None posted
Sep 29, 1983	Supplement 5Labeling	Approved	None posted
Jun 15, 1983	Supplement 3Labeling	Approved	None posted
Jun 9, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 11, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18354
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil-Janssen Pharmaceuticals

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