Ovral

NDA 16672, held by Wyeth Pharms. Ethinyl Estradiol; Norgestrel.

As of Nov 13, 2026, NDA 16672 (Ovral), held by Wyeth Pharms, was first approved by FDA on Apr 16, 1968, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 16, 1968
Review: Priority
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Apr 16, 1968	Original applicationNew molecular entity, new combination · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ovral0.05MG;0.5MG · tablet;oral-21	Ethinyl Estradiol; Norgestrel	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Mar 6, 2002	Supplement 50Manufacturing · Priority review	Approved	None posted
Mar 23, 2001	Supplement 46Labeling · Standard review	Approved	Review Letter
Jul 8, 1998	Supplement 48Manufacturing · Priority review	Approved	None posted
Aug 14, 1997	Supplement 47Labeling · Standard review	Approved	Review
Nov 29, 1994	Supplement 45Labeling · Standard review	Approved	None posted
Jan 28, 1994	Supplement 44Labeling · Standard review	Approved	None posted
Dec 23, 1993	Supplement 43Manufacturing · Priority review	Approved	None posted
Aug 8, 1990	Supplement 40Labeling	Approved	None posted
Apr 18, 1989	Supplement 42Manufacturing · Priority review	Approved	None posted
Oct 19, 1988	Supplement 34Manufacturing · Priority review	Approved	None posted
Apr 27, 1988	Supplement 41Manufacturing · Priority review	Approved	None posted
Jul 15, 1986	Supplement 38Labeling	Approved	None posted
Feb 19, 1986	Supplement 37Manufacturing · Priority review	Approved	None posted
Jan 7, 1986	Supplement 35Manufacturing · Priority review	Approved	None posted
Oct 16, 1985	Supplement 36Labeling	Approved	None posted
Feb 19, 1985	Supplement 32Manufacturing · Priority review	Approved	None posted
Jul 26, 1984	Supplement 33Labeling	Approved	None posted
Feb 21, 1980	Supplement 28Manufacturing · Priority review	Approved	None posted
Dec 7, 1978	Supplement 19Labeling	Approved	None posted
Nov 22, 1977	Supplement 25Labeling	Approved	None posted
Apr 16, 1968	Original applicationNew molecular entity, new combination · Priority review	Approved	None posted

Identifiers

Application: NDA 16672
Drugs@FDA: Overview at FDA
Company: Wyeth 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