Demulen 1/50-21

NDA 16927, held by Gd Searle LLC. Ethinyl Estradiol; Ethynodiol Diacetate.

As of Nov 13, 2026, NDA 16927 (Demulen 1/50-21), held by Gd Searle LLC, was first approved by FDA on Apr 24, 1970, with 19 approved supplements and 0 published complete response letters.

First approved: Apr 24, 1970
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
Apr 24, 1970	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Demulen 1/50-210.05MG;1MG · tablet;oral-21	Ethinyl Estradiol; Ethynodiol Diacetate	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Sep 2, 1999	Supplement 62Labeling · Standard review	Approved	None posted
Apr 20, 1994	Supplement 61Labeling · Standard review	Approved	None posted
Apr 28, 1993	Supplement 60Labeling · Standard review	Approved	None posted
Dec 16, 1991	Supplement 59Manufacturing · Standard review	Approved	None posted
Nov 14, 1991	Supplement 51Labeling · Standard review	Approved	None posted
Aug 7, 1991	Supplement 58Manufacturing · Standard review	Approved	None posted
Oct 28, 1988	Supplement 54Manufacturing · Standard review	Approved	None posted
Oct 23, 1986	Supplement 49Labeling · Standard review	Approved	None posted
Jun 10, 1986	Supplement 48Labeling · Standard review	Approved	None posted
Mar 13, 1986	Supplement 47Labeling · Standard review	Approved	None posted
Jun 5, 1985	Supplement 46Labeling · Standard review	Approved	None posted
Apr 5, 1985	Supplement 45Labeling · Standard review	Approved	None posted
Feb 12, 1985	Supplement 44Labeling · Standard review	Approved	None posted
Sep 18, 1984	Supplement 43Labeling · Standard review	Approved	None posted
Mar 6, 1984	Supplement 41Labeling · Standard review	Approved	None posted
Jun 9, 1983	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 3, 1983	Supplement 39Manufacturing · Standard review	Approved	None posted
Nov 22, 1982	Supplement 36Manufacturing · Standard review	Approved	None posted
Mar 6, 1981	Supplement 33Manufacturing · Standard review	Approved	None posted
Apr 24, 1970	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 16927
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