Ethinyl Estradiol; Ethynodiol Diacetate

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Apr 24, 1970	Demulen 1/50-21NDA 16927 · New combination	Gd Searle LLC	19	Discontinued
Dec 8, 1970	Demulen 1/50-28NDA 16936 · New dosage form	Gd Searle LLC	16	Discontinued
Dec 30, 1981	Demulen 1/35-28NDA 18160 · New dosage form	Gd Searle LLC	20	Discontinued
Dec 30, 1981	Demulen 1/35-21NDA 18168 · New dosage form	Gd Searle LLC	16	Discontinued
Dec 30, 1991	Zovia 1/35e-21ANDA 72720	Watson Pharms Teva	12	Discontinued
Dec 30, 1991	Zovia 1/35e-28ANDA 72721	Dr Reddys Labs SA	12	Discontinued
Dec 30, 1991	Zovia 1/50e-21ANDA 72722	Watson Labs	12	Discontinued
Dec 30, 1991	Kelnor 1/50ANDA 72723	Watson Labs	13	Discontinued
May 23, 2005	KelnorANDA 76785	Barr	2	Marketed
Feb 9, 2016	Ethynodiol Diacetate And Ethinyl EstradiolANDA 204704	Xiromed	2	Marketed
Jul 28, 2016	Ethynodiol Diacetate And Ethinyl EstradiolANDA 204703	Xiromed	2	Marketed
Jul 25, 2018	MalmoredeANDA 209547	Novast Labs	0	Marketed
Feb 11, 2019	Lo-MalmoredeANDA 209548	Novast Labs	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA