Lo/Ovral

NDA 17612, held by Cadence Health. Ethinyl Estradiol; Norgestrel.

As of Nov 14, 2026, NDA 17612 (Lo/Ovral), held by Cadence Health, was first approved by FDA on Mar 17, 1975, with 23 approved supplements and 0 published complete response letters.

First approved: Mar 17, 1975
Review: Priority
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Mar 17, 1975	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lo/Ovral0.03MG;0.3MG · tablet;oral-21	Ethinyl Estradiol; Norgestrel	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Oct 31, 2022	Supplement 45Labeling · Standard review	Approved	Label Letter
Apr 29, 2022	Supplement 44Labeling · Standard review	Approved	Letter Label
Aug 9, 2017	Supplement 43Labeling · Standard review	Approved	Letter Label
Mar 6, 2002	Supplement 35Manufacturing · Priority review	Approved	None posted
Apr 3, 2000	Supplement 31Labeling · Standard review	Approved	Review
Jul 8, 1998	Supplement 33Manufacturing · Priority review	Approved	None posted
Nov 29, 1994	Supplement 30Labeling · Standard review	Approved	None posted
Jan 28, 1994	Supplement 29Labeling · Standard review	Approved	None posted
Dec 23, 1993	Supplement 28Manufacturing · Priority review	Approved	None posted
Aug 8, 1990	Supplement 25Labeling	Approved	None posted
Apr 18, 1989	Supplement 27Manufacturing · Priority review	Approved	None posted
Oct 19, 1988	Supplement 18Manufacturing · Priority review	Approved	None posted
Apr 27, 1988	Supplement 26Manufacturing · Priority review	Approved	None posted
Jul 15, 1986	Supplement 22Labeling	Approved	None posted
Feb 19, 1986	Supplement 21Manufacturing · Priority review	Approved	None posted
Jan 7, 1986	Supplement 19Manufacturing · Priority review	Approved	None posted
Oct 16, 1985	Supplement 20Labeling	Approved	None posted
Feb 19, 1985	Supplement 16Manufacturing · Priority review	Approved	None posted
Jul 26, 1984	Supplement 17Labeling	Approved	None posted
Jan 13, 1984	Supplement 15Labeling	Approved	None posted
Feb 28, 1980	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 20, 1978	Supplement 6Labeling	Approved	None posted
Nov 22, 1977	Supplement 9Labeling	Approved	None posted
Mar 17, 1975	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 17612
Drugs@FDA: Overview at FDA
Company: Cadence Health

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