Norinyl 1+80 21-Day

NDA 16724, held by Gd Searle LLC. Mestranol; Norethindrone.

As of Nov 13, 2026, NDA 16724 (Norinyl 1+80 21-Day), held by Gd Searle LLC, was first approved by FDA on Nov 6, 1968, with 38 approved supplements and 0 published complete response letters.

First approved: Nov 6, 1968
Review: Standard
Supplements approved: 38
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 39 submissions below

Date	Submission	Status	Documents
Nov 6, 1968	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norinyl 1+80 21-Day0.08MG;1MG · tablet;oral-21	Mestranol; Norethindrone	Discontinued

All 39 submissions, including labeling and manufacturing supplements


Jul 17, 1986	Supplement 108Labeling	Approved	None posted
Oct 25, 1985	Supplement 107Labeling	Approved	None posted
Apr 16, 1985	Supplement 106Labeling	Approved	None posted
Nov 13, 1984	Supplement 104Manufacturing · Standard review	Approved	None posted
Sep 27, 1984	Supplement 101Manufacturing · Standard review	Approved	None posted
Jul 30, 1984	Supplement 103Labeling	Approved	None posted
May 7, 1984	Supplement 100Labeling	Approved	None posted
Mar 6, 1984	Supplement 96Labeling	Approved	None posted
Jul 26, 1983	Supplement 99Manufacturing · Standard review	Approved	None posted
Jul 26, 1983	Supplement 95Manufacturing · Standard review	Approved	None posted
Jul 19, 1983	Supplement 98Manufacturing · Standard review	Approved	None posted
Jul 19, 1983	Supplement 97Manufacturing · Standard review	Approved	None posted
Jun 13, 1983	Supplement 94Manufacturing · Standard review	Approved	None posted
Jul 29, 1982	Supplement 90Manufacturing · Standard review	Approved	None posted
Jan 11, 1982	Supplement 86Manufacturing · Standard review	Approved	None posted
Oct 14, 1980	Supplement 46Labeling	Approved	None posted
Apr 17, 1980	Supplement 81Manufacturing · Standard review	Approved	None posted
Jul 18, 1979	Supplement 80Manufacturing · Standard review	Approved	None posted
Jul 18, 1979	Supplement 77Manufacturing · Standard review	Approved	None posted
Nov 6, 1978	Supplement 71Manufacturing · Standard review	Approved	None posted
Nov 6, 1978	Supplement 68Manufacturing · Standard review	Approved	None posted
May 26, 1978	Supplement 67Manufacturing · Standard review	Approved	None posted
Nov 22, 1977	Supplement 58Labeling	Approved	None posted
Nov 22, 1977	Supplement 57Labeling	Approved	None posted
Jul 1, 1977	Supplement 48Labeling	Approved	None posted
Jul 1, 1977	Supplement 47Labeling	Approved	None posted
Jun 14, 1977	Supplement 55Labeling	Approved	None posted
Jun 14, 1977	Supplement 54Labeling	Approved	None posted
Jun 14, 1977	Supplement 53Labeling	Approved	None posted
Jun 14, 1977	Supplement 52Labeling	Approved	None posted
Sep 29, 1976	Supplement 45Manufacturing · Standard review	Approved	None posted
May 16, 1975	Supplement 42Labeling	Approved	None posted
May 16, 1975	Supplement 40Manufacturing · Standard review	Approved	None posted
May 16, 1975	Supplement 37Manufacturing · Standard review	Approved	None posted
May 16, 1975	Supplement 34Manufacturing · Standard review	Approved	None posted
May 16, 1975	Supplement 33Manufacturing · Standard review	Approved	None posted
May 16, 1975	Supplement 30Manufacturing · Standard review	Approved	None posted
May 16, 1975	Supplement 29Labeling	Approved	None posted
Nov 6, 1968	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16724
Drugs@FDA: Overview at FDA
Company: G.D. Searle

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