Ortho-Novum 7/14-21, Ortho-Novum 7/14-28

NDA 19004, held by Ortho Mcneil Pharm. Ethinyl Estradiol; Norethindrone.

As of Nov 13, 2026, NDA 19004 (Ortho-Novum 7/14-21, Ortho-Novum 7/14-28), held by Ortho Mcneil Pharm, was first approved by FDA on Apr 4, 1984, with 24 approved supplements and 0 published complete response letters.

First approved: Apr 4, 1984
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Apr 4, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Ortho-Novum 7/14-210.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-21	Ethinyl Estradiol; Norethindrone	Discontinued
Ortho-Novum 7/14-280.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-28	Ethinyl Estradiol; Norethindrone	Discontinued

All 25 submissions, including labeling and manufacturing supplements


Jun 3, 2002	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 21, 2002	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 9, 2001	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 28, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 13, 1998	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 24, 1997	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 29, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
May 10, 1996	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 30, 1995	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 7, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 16, 1995	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 29, 1994	Supplement 17Labeling · Standard review	Approved	None posted
Mar 7, 1994	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 4, 1993	Supplement 16Manufacturing · Standard review	Approved	None posted
May 18, 1993	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 23, 1991	Supplement 11Labeling · Standard review	Approved	None posted
Sep 16, 1991	Supplement 10Labeling · Standard review	Approved	None posted
Mar 18, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 18, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 16, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 17, 1989	Supplement 2Labeling · Standard review	Approved	None posted
Feb 14, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 14, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 14, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 4, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19004
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil Pharmaceutical

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