Dienestrol

NDA 6110, held by Ortho Mcneil Pharm. Dienestrol.

As of Nov 14, 2026, NDA 6110 (Dienestrol), held by Ortho Mcneil Pharm, was first approved by FDA on Jan 9, 1947, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 9, 1947
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jul 29, 1980	Supplement 19Efficacy (new indication or use)	Approved	None posted
Apr 25, 1980	Supplement 17Efficacy (new indication or use)	Approved	None posted
Apr 25, 1980	Supplement 16Efficacy (new indication or use)	Approved	None posted
Jun 21, 1979	Supplement 15Efficacy (new indication or use)	Approved	None posted
Jan 9, 1947	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dienestrol0.01% · cream;vaginal	Dienestrol	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Apr 1, 1988	Supplement 27Manufacturing	Approved	None posted
Dec 7, 1987	Supplement 28Labeling	Approved	None posted
Nov 26, 1986	Supplement 26Labeling	Approved	None posted
Jan 24, 1985	Supplement 24Manufacturing	Approved	None posted
Jun 1, 1984	Supplement 23Manufacturing	Approved	None posted
Feb 8, 1984	Supplement 21Labeling	Approved	None posted
Jun 9, 1983	Supplement 22Manufacturing	Approved	None posted
Jul 8, 1982	Supplement 20Manufacturing	Approved	None posted
Jul 29, 1980	Supplement 19Efficacy (new indication or use)	Approved	None posted
Apr 25, 1980	Supplement 17Efficacy (new indication or use)	Approved	None posted
Apr 25, 1980	Supplement 16Efficacy (new indication or use)	Approved	None posted
Apr 25, 1980	Supplement 14Manufacturing	Approved	None posted
Jun 21, 1979	Supplement 15Efficacy (new indication or use)	Approved	None posted
Apr 17, 1978	Supplement 11Manufacturing	Approved	None posted
Jan 11, 1978	Supplement 12Labeling	Approved	None posted
May 25, 1977	Supplement 8Labeling	Approved	None posted
Sep 27, 1976	Supplement 6Manufacturing	Approved	None posted
Mar 10, 1976	Supplement 5Labeling	Approved	None posted
Jan 9, 1947	Original application	Approved	None posted

Identifiers

Application: NDA 6110
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil Pharmaceutical

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