Lo/Ovral-28

NDA 17802, held by Wyeth Pharms. Ethinyl Estradiol; Norgestrel.

As of Nov 13, 2026, NDA 17802 (Lo/Ovral-28), held by Wyeth Pharms, was first approved by FDA on Mar 16, 1976, with 21 approved supplements and 0 published complete response letters.

First approved: Mar 16, 1976
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Mar 16, 1976	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lo/Ovral-280.03MG;0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-28	Ethinyl Estradiol; Norgestrel	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 29, 2022	Supplement 35Labeling · Standard review	Approved	Letter Label
May 8, 2019	Supplement 34Labeling · Standard review	Approved	Label Letter
Mar 20, 2018	Supplement 33Labeling · Standard review	Approved	Letter Label
Aug 9, 2017	Supplement 32Labeling · Standard review	Approved	Letter Label
Jun 8, 2017	Supplement 29Labeling · Standard review	Approved	Label Letter
Mar 6, 2002	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 3, 2000	Supplement 18Labeling · Standard review	Approved	Label Review
Jul 8, 1998	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 29, 1994	Supplement 16Labeling · Standard review	Approved	None posted
Jan 28, 1994	Supplement 17Labeling · Standard review	Approved	None posted
Dec 23, 1993	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 8, 1990	Supplement 13Labeling	Approved	None posted
Apr 27, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 15, 1986	Supplement 11Labeling	Approved	None posted
Feb 19, 1986	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 16, 1985	Supplement 9Labeling	Approved	None posted
Apr 5, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 4, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 26, 1984	Supplement 7Labeling	Approved	None posted
Jan 8, 1979	Supplement 2Labeling	Approved	None posted
Dec 8, 1977	Supplement 3Labeling	Approved	None posted
Mar 16, 1976	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17802
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