Ovcon-50

NDA 18128, held by Warner Chilcott. Ethinyl Estradiol; Norethindrone.

As of Nov 13, 2026, NDA 18128 (Ovcon-50), held by Warner Chilcott, was first approved by FDA on Jul 5, 1978, with 19 approved supplements and 0 published complete response letters.

First approved: Jul 5, 1978
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jul 5, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ovcon-500.05MG;1MG · tablet;oral-21	Ethinyl Estradiol; Norethindrone	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Nov 14, 1997	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 25, 1995	Supplement 27Labeling · Standard review	Approved	None posted
May 24, 1994	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 12, 1993	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 12, 1993	Supplement 25Labeling · Standard review	Approved	None posted
Jul 21, 1992	Supplement 23Labeling	Approved	None posted
Jan 2, 1991	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 24, 1989	Supplement 19Labeling	Approved	None posted
Mar 18, 1986	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 10, 1986	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 3, 1984	Supplement 12Labeling	Approved	None posted
Oct 1, 1984	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 8, 1984	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 25, 1983	Supplement 11Labeling	Approved	None posted
Apr 14, 1981	Supplement 8Labeling	Approved	None posted
Jan 22, 1980	Supplement 5Labeling	Approved	None posted
Jul 31, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 4, 1979	Supplement 3Labeling	Approved	None posted
Jan 19, 1979	Supplement 1Labeling	Approved	None posted
Jul 5, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18128
Drugs@FDA: Overview at FDA
Company: Warner Chilcott Company

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