Demulen 1/50-28

NDA 16936, held by Gd Searle LLC. Ethinyl Estradiol; Ethynodiol Diacetate.

As of Nov 13, 2026, NDA 16936 (Demulen 1/50-28), held by Gd Searle LLC, was first approved by FDA on Dec 8, 1970, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 8, 1970
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 8, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Demulen 1/50-280.05MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-28	Ethinyl Estradiol; Ethynodiol Diacetate	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Dec 27, 1996	Supplement 42Manufacturing · Standard review	Approved	None posted
Apr 20, 1994	Supplement 40Labeling · Standard review	Approved	None posted
Apr 28, 1993	Supplement 39Labeling · Standard review	Approved	None posted
Dec 16, 1991	Supplement 38Manufacturing · Standard review	Approved	None posted
Nov 14, 1991	Supplement 30Labeling · Standard review	Approved	None posted
Aug 7, 1991	Supplement 37Manufacturing · Standard review	Approved	None posted
Oct 28, 1988	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 23, 1986	Supplement 28Labeling · Standard review	Approved	None posted
Jun 10, 1986	Supplement 27Labeling · Standard review	Approved	None posted
Mar 13, 1986	Supplement 26Labeling · Standard review	Approved	None posted
Jun 5, 1985	Supplement 25Labeling · Standard review	Approved	None posted
Apr 5, 1985	Supplement 24Labeling · Standard review	Approved	None posted
Feb 12, 1985	Supplement 23Labeling · Standard review	Approved	None posted
Sep 18, 1984	Supplement 22Labeling · Standard review	Approved	None posted
Mar 6, 1984	Supplement 20Labeling · Standard review	Approved	None posted
Mar 3, 1981	Supplement 15Labeling · Standard review	Approved	None posted
Dec 8, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16936
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