Ethinyl Estradiol; Norethindrone

Sold as Modicon 21, Ortho-Novum 1/35-21, Norinyl 1+35 21-Day, Norinyl 1+35 28-Day, Brevicon 21-Day and 15 more. Every FDA application for this active ingredient: 17 branded and 59 generic.

As of Nov 15, 2026, FDA lists 76 applications for Ethinyl Estradiol; Norethindrone (sold as Modicon 21, Ortho-Novum 1/35-21, Norinyl 1+35 21-Day and others), first approved Oct 15, 1974, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 15, 1974
Applications: 76
New uses approved: 0
Complete response letters: 0

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effects of VX-407 on the Pharmacokinetics of Combined Oral ContraceptivesAutosomal Dominant Polycystic Kidney Disease (ADPKD) · Vertex Pharmaceuticals Incorporated	Phase 1	Recruiting	Aug 28, 2026
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy ParticipantsHealthy Volunteers · Eisai Inc.	Phase 1	Recruiting	Aug 14, 2026
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary DiseaseArginine Vasopressin Deficiency, Oxytocin Deficiency · Massachusetts General Hospital	Early phase 1	Recruiting	May 5, 2026
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered TogetherHealthy Volunteers · Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 1	Recruiting	Mar 3, 2026
International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)Contraception · Center for Epidemiology and Health Research, Germany	—	Recruiting	Dec 29, 2023

Applications

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


Oct 15, 1974	Modicon 21NDA 17488 · New dosage form	Ortho Mcneil Pharm	69	Discontinued
Oct 15, 1974	Ortho-Novum 1/35-21NDA 17489 · New dosage form	Ortho Mcneil Pharm	62	Discontinued
Dec 26, 1974	Brevicon 21-DayNDA 17566 · New formulation or manufacturer	Allergan	51	Discontinued
Dec 27, 1974	Norinyl 1+35 21-Day, Norinyl 1+35 28-DayNDA 17565 · New formulation or manufacturer	Allergan	48	Discontinued
Aug 28, 1975	Ovcon-50NDA 17576 · New dosage form	Warner Chilcott LLC	34	Discontinued
Mar 29, 1976	Ovcon-35NDA 17716 · New dosage form	Warner Chilcott LLC	34	Discontinued
Mar 29, 1976	Brevicon 28-DayNDA 17743 · New dosage form	Allergan	45	Discontinued
May 14, 1976	Modicon 28NDA 17735 · New formulation or manufacturer	Janssen Pharms	71	Discontinued
Jun 23, 1977	Ortho-Novum 1/35-28NDA 17919 · New dosage form	Janssen Pharms	65	Discontinued
Jul 5, 1978	Ovcon-35NDA 18127 · New dosage form	Warner Chilcott	25	Discontinued
Jul 5, 1978	Ovcon-50NDA 18128 · New dosage form	Warner Chilcott	19	Discontinued
Jan 11, 1982	Ortho-Novum 10/11-21, Ortho-Novum 10/11-28NDA 18354 · New dosage form	Ortho Mcneil Janssen	40	Discontinued
Apr 4, 1984	Ortho-Novum 7/7/7-21, Ortho-Novum 7/7/7-28NDA 18985 · New dosage form	Janssen Pharms	42	Discontinued
Apr 4, 1984	Ortho-Novum 7/14-21, Ortho-Novum 7/14-28NDA 19004 · New dosage form	Ortho Mcneil Pharm	24	Discontinued
Apr 11, 1984	Tri-Norinyl 21-Day, Tri-Norinyl 28-DayNDA 18977 · New dosage form	Dr Reddys Labs SA	28	Marketed
Jan 29, 1987	Norethindrone And Ethinyl EstradiolANDA 70684	Watson Labs	15	Discontinued
Jan 29, 1987	Norethindrone And Ethinyl EstradiolANDA 70686	Dr Reddys Labs SA	15	Discontinued
Jan 29, 1987	Norethindrone And Ethinyl EstradiolANDA 70685	Watson Pharms Teva	17	Discontinued
Jan 29, 1987	Norethindrone And Ethinyl EstradiolANDA 70687	Watson Labs Teva	18	Marketed
Dec 14, 1987	N.E.E. 1/35 28ANDA 71542	Lpi	0	Discontinued
Dec 14, 1987	N.E.E. 1/35 21ANDA 71541	Lpi	0	Discontinued
Apr 1, 1988	Norethindrone And Ethinyl EstradiolANDA 71043	Watson Labs	13	Discontinued
Apr 1, 1988	Norethindrone And Ethinyl EstradiolANDA 71044	Watson Labs Teva	13	Marketed
Apr 12, 1988	Norethin 1/35e-21ANDA 71480	Watson Pharms Teva	11	Discontinued
Apr 12, 1988	Norethin 1/35e-28ANDA 71481	Watson Labs	14	Discontinued
Feb 9, 1989	Norcept-E 1/35 21ANDA 71545	Ortho Mcneil Pharm	2	Discontinued
Feb 9, 1989	Norcept-E 1/35 28ANDA 71546	Ortho Mcneil Pharm	2	Discontinued
Sep 24, 1991	Norethindrone And Ethinyl EstradiolANDA 71041	Watson Labs Teva	5	Discontinued
Sep 24, 1991	Norethindrone And Ethinyl EstradiolANDA 71042	Watson Labs	5	Discontinued
Feb 28, 1992	Nortrel 0.5/35-21ANDA 72692	Barr	11	Discontinued
Feb 28, 1992	Nortrel 1/35-21ANDA 72693	Barr	16	Marketed
Feb 28, 1992	Gencept 10/11-21ANDA 72694	Barr	2	Discontinued
Feb 28, 1992	Gencept 10/11-28ANDA 72697	Barr Labs	2	Discontinued
Feb 28, 1992	Nortrel 0.5/35-28ANDA 72695	Barr Labs	16	Marketed
Feb 28, 1992	Nortrel 1/35-28ANDA 72696	Barr Labs	16	Marketed
Aug 30, 2002	Nortrel 7/7/7ANDA 75478	Barr	6	Marketed
Nov 14, 2003	Femcon FeNDA 21490 · New dosage form	Apil	10	Discontinued
Apr 22, 2004	Balziva-21ANDA 76198	Barr	0	Discontinued
Apr 22, 2004	Balziva-28ANDA 76238	Barr	2	Marketed
Sep 29, 2004	AranelleANDA 76783	Barr	2	Marketed
Feb 4, 2010	Norethindrone And Ethinyl EstradiolANDA 76393	Watson Labs	2	Discontinued
Feb 4, 2010	Norethindrone And Ethinyl EstradiolANDA 78323	Watson Labs	2	Marketed
Feb 23, 2010	Norethindrone And Ethinyl EstradiolANDA 78379	Watson Labs	2	Discontinued
Aug 5, 2010	Norethindrone And Ethinyl Estradiol And Ferrous FumarateANDA 78965	Barr	2	Marketed
Nov 12, 2010	Cyclafem 1/35ANDA 76337	Ph Health	6	Discontinued
Nov 16, 2010	Cyclafem 7/7/7ANDA 76338	Ph Health	5	Discontinued
Dec 22, 2010	Norethindrone And Ethinyl Estradiol And Ferrous FumarateNDA 22573 · New formulation or manufacturer	Teva Branded Pharm	7	Discontinued
Mar 22, 2011	BriellynANDA 90538	Glenmark Pharms Ltd	3	Marketed
Sep 26, 2011	Norethindrone And Ethinyl Estradiol And Ferrous FumarateANDA 78892	Amneal Pharms	1	Marketed
Dec 22, 2011	Dasetta 7/7/7ANDA 90946	Novast Labs Ltd	5	Marketed
Dec 22, 2011	PhilithANDA 90947	Novast Labs Ltd	2	Marketed
Dec 22, 2011	Dasetta 1/35ANDA 90948	Novast Labs Ltd	5	Marketed
Jan 19, 2012	Alyacen 7/7/7, Alyacen 777ANDA 91636	Glenmark Pharms Ltd	5	Marketed
Jan 19, 2012	Alyacen 1/35ANDA 91634	Glenmark Pharms Ltd	5	Marketed
Mar 27, 2012	WeraANDA 91204	Novast Labs Ltd	5	Marketed
Nov 6, 2012	GildagiaANDA 78376	Ph Health	2	Discontinued
Apr 24, 2013	Pirmella 7/7/7ANDA 201510	Lupin Ltd	5	Discontinued
Apr 24, 2013	Pirmella 1/35ANDA 201512	Lupin Ltd	5	Discontinued
Aug 5, 2013	Norethindrone And Ethinyl EstradiolANDA 203006	Xiromed	2	Discontinued
Sep 26, 2013	VyfemlaANDA 201886	Lupin	3	Marketed
Apr 23, 2014	Norethindrone And Ethinyl Estradiol And Ferrous FumarateANDA 203371	Xiromed	0	Marketed
Apr 1, 2015	Norethindrone And Ethinyl Estradiol And Ferrous FumarateANDA 202086	Xiromed	3	Marketed
May 11, 2015	Norethindrone And Ethinyl EstradiolANDA 200897	Xiromed	2	Discontinued
Oct 21, 2015	Norethindrone And Ethinyl EstradiolANDA 200488	Mylan Labs Ltd	1	Discontinued
Oct 21, 2015	Norethindrone And Ethinyl EstradiolANDA 200489	Mylan Labs Ltd	1	Discontinued
Dec 16, 2015	Cyclafem 0.5/35ANDA 203413	Ph Health	2	Discontinued
Dec 17, 2015	Kaitlib FeANDA 203448	Lupin	2	Marketed
Dec 28, 2015	Norethindrone And Ethinyl EstradiolANDA 200486	Mylan Labs Ltd	0	Discontinued
Mar 23, 2016	Norethindrone And Ethinyl Estradiol And Ferrous FumarateANDA 91332	Lupin	4	Marketed
Oct 21, 2016	Nylia 7/7/7ANDA 207054	Aurobindo Pharma	2	Marketed
Oct 21, 2016	CyonanzANDA 207055	Aurobindo Pharma	2	Marketed
Oct 21, 2016	Nylia 1/35ANDA 207056	Aurobindo Pharma	2	Marketed
Feb 2, 2017	Nexesta FeANDA 207535	Aurobindo Pharma	2	Marketed
Mar 29, 2017	Norethindrone And Ethinyl Estradiol And Ferrous FumarateANDA 207066	Naari Pte	1	Marketed
Apr 28, 2017	Norethindrone And Ethinyl EstradiolANDA 206864	Naari Pte	1	Marketed
Oct 11, 2022	RhuzdahANDA 207585	Aurobindo Pharma	0	Discontinued

Show all 76

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