Ethinyl Estradiol; Levonorgestrel

For a BMI < 30 kg/m. Sold as Nordette-21, Nordette-28, Triphasil-28, Triphasil-21, Alesse and 10 more. Every FDA application for this active ingredient: 15 branded and 63 generic.

As of Nov 15, 2026, FDA lists 78 applications for Ethinyl Estradiol; Levonorgestrel (sold as Nordette-21, Nordette-28, Triphasil-28 and others), first approved May 10, 1982, with 1 new use approved and 3 published complete response letters.

First approved: May 10, 1982
Applications: 78
New uses approved: 1
Complete response letters: 3

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TWIRLA 120-30 MCG/DAY PATCH: $66.99 per unitBrand · +3% in a year
BALCOLTRA TABLET: $10.04 per unitBrand · +3% in a year
TYBLUME 0.1-0.02 MG CHEW TAB: $0.828 per unitBrand · +10% in a year

Clinical Trials

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


A Study of Eloralintide (LY3841136) in Female Participants With Obesity or OverweightObesity, Overweight · Eli Lilly and Company	Phase 1	Recruiting	Sep 8, 2026
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 Investigate the Repeat-dose Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With Ganfeborole in Female Participants of Non-childbearing PotentialTuberculosis · GlaxoSmithKline	Phase 1	Recruiting	Aug 25, 2026
A Research Study Looking Into How UBT251 Works With Birth Control Tablets and Emptying of the Stomach in Women With Excess Body Weight Not Able to Become PregnantOverweight, Obesity · Novo Nordisk A/S	Phase 1	Recruiting	Jul 17, 2026
Teen Vulnerability to Irritability: Brain and Estrogen ChangesDepression - Major Depressive Disorder, Irritability · University of North Carolina, Chapel Hill	Phase 4	Not yet recruiting	Apr 22, 2026
Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive PillContraception · Dr. Hang Wun Raymond Li	Phase 3	Not yet recruiting	Apr 17, 2026
A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body WeightOverweight, Obesity · Novo Nordisk A/S	Phase 1	Active, not recruiting	Apr 13, 2026
Reversible Effects of Oral Contraceptive Removal on Serotonergic NeurotransmissionThe Focus of the Study is to Investigate Reversible Effects of Combined Oral Contraceptive Use on Serotonergic Neurotransmission, Healthy Adult Females · Copenhagen University Hospital, Rigshospitalet	Phase 4	Recruiting	Apr 6, 2026

Applications

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


May 10, 1982	Nordette-21NDA 18668 · New dosage form	Teva Branded Pharm	35	Discontinued
Jul 21, 1982	Nordette-28NDA 18782 · New formulation or manufacturer	Teva Branded Pharm	30	Discontinued
Nov 1, 1984	Triphasil-28NDA 19190 · New dosage form	Wyeth Pharms Inc	38	Discontinued
Nov 1, 1984	Triphasil-21NDA 19192 · New dosage form	Wyeth Pharms	37	Discontinued
Dec 13, 1993	Levora 0.15/30-21ANDA 73592	Watson Labs	7	Discontinued
Dec 13, 1993	Levora 0.15/30-28ANDA 73594	Dr Reddys Labs SA	10	Marketed
Mar 27, 1997	AlesseNDA 20683 · New dosage form	Cadence Health	9	Discontinued
Dec 18, 1997	Trivora-21, Trivora-28ANDA 74538	Dr Reddys Labs SA	6	Marketed
Jul 13, 1998	LevliteNDA 20860 · New dosage form	Bayer Hlthcare	2	Discontinued
Sep 1, 1998	Preven Emergency ContraceptiveNDA 20946 · New dosage form	Teva Branded Pharm	10	Discontinued
Apr 30, 2001	Aviane-28, Aviane-21ANDA 75796	Duramed Pharms Barr	8	Marketed
Jul 16, 2001	Enpresse-21, Enpresse-28ANDA 75809	Duramed Pharms Barr	7	Marketed
Mar 20, 2002	Lessina-21, Lessina-28ANDA 75803	Barr	6	Marketed
May 23, 2002	Portia-21, Portia-28ANDA 75866	Barr	10	Marketed
Apr 29, 2003	Levonorgestrel And Ethinyl EstradiolANDA 75862	Barr	0	Discontinued
Sep 5, 2003	SeasonaleNDA 21544 · New dosage form	Teva Branded Pharm	7	Marketed
Nov 18, 2004	Levonorgestrel And Ethinyl EstradiolANDA 76625	Dr Reddys Labs SA	4	Marketed
May 25, 2006	SeasoniqueNDA 21840 · New dosage form	Teva Branded Pharm	6	Marketed
May 31, 2006	Levonorgestrel And Ethinyl EstradiolANDA 77681	Dr Reddys Labs SA	2	Marketed
Sep 6, 2006	QuasenseANDA 77101	Watson Labs	0	Marketed
May 22, 2007	LybrelNDA 21864 · New formulation or manufacturer	Wyeth Pharms Inc	3	Discontinued
Oct 24, 2008	LoseasoniqueNDA 22262 · New dosage form	Teva Branded Pharm	5	Marketed
Aug 3, 2010	AltaveraANDA 79102	Xiromed	6	Marketed
Sep 27, 2010	IntrovaleANDA 79064	Xiromed	5	Marketed
Dec 29, 2010	LevonestANDA 90719	Novast Labs Ltd	3	Marketed
May 11, 2011	OrsythiaANDA 77099	Ph Health	4	Discontinued
May 31, 2011	Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolANDA 78834	Dr Reddys Labs SA	0	Marketed
Jun 6, 2011	Levonorgestrel And Ethinyl EstradiolANDA 79218	Watson Labs	3	Marketed
Oct 25, 2011	Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolANDA 200407	Dr Reddys Labs SA	0	Discontinued
Oct 26, 2011	Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolANDA 91674	Lupin Ltd	5	Marketed
Nov 23, 2011	MyzilraANDA 77502	Ph Health	3	Discontinued
Feb 29, 2012	MarlissaANDA 91452	Glenmark Pharms Ltd	8	Marketed
Mar 28, 2012	FalminaANDA 90721	Novast Labs Ltd	2	Marketed
Oct 17, 2012	KurveloANDA 91408	Lupin Ltd	8	Marketed
Oct 23, 2012	Levonorgestrel And Ethinyl EstradiolANDA 91440	Lupin Ltd	4	Marketed
Dec 21, 2012	Levonorgestrel And Ethinyl EstradiolANDA 91663	Xiromed	6	Marketed
Jan 18, 2013	Levonorgestrel And Ethinyl EstradiolANDA 91425	Lupin Ltd	2	Marketed
Mar 28, 2013	QuartetteNDA 204061 · New formulation or manufacturer	Teva Branded Pharm	4	Marketed
Apr 10, 2013	DayseeANDA 91467	Lupin Ltd	1	Marketed
Oct 9, 2013	Levonorgestrel And Ethinyl EstradiolANDA 200245	Xiromed	3	Marketed
Feb 5, 2014	Levonorgestrel And Ethinyl EstradiolANDA 201108	Amneal Pharms	2	Discontinued
Sep 15, 2014	SetlakinANDA 90716	Novast Labs	3	Marketed
Dec 8, 2014	Levonorgestrel And Ethinyl EstradiolANDA 201095	Amneal Pharms	2	Discontinued
Dec 8, 2014	Levonorgestrel And Ethinyl EstradiolANDA 202247	Xiromed	2	Discontinued
Feb 23, 2015	AshlynaANDA 203163	Glenmark Pharms Ltd	3	Marketed
Apr 9, 2015	Levonorgestrel And Ethinyl EstradiolANDA 202791	Glenmark Pharms Ltd	4	Marketed
Apr 21, 2015	Levonorgestrel And Ethinyl EstradiolANDA 200490	Xiromed	4	Marketed
May 21, 2015	VienvaANDA 201088	Xiromed	2	Marketed
May 27, 2015	Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolANDA 200492	Xiromed	4	Marketed
Jun 12, 2015	Levonorgestrel And Ethinyl EstradiolANDA 203164	Glenmark Pharms Ltd	4	Marketed
Jun 17, 2015	Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolANDA 200493	Xiromed	4	Marketed
Nov 13, 2015	Levonorgestrel And Ethinyl EstradiolANDA 203871	Naari Pte	1	Marketed
Nov 19, 2015	Levonorgestrel And Ethinyl EstradiolANDA 200248	Lupin	3	Marketed
Dec 4, 2015	ElifemmeANDA 202507	Xiromed	3	Discontinued
Dec 22, 2015	Levonorgestrel And Ethinyl EstradiolANDA 203872	Naari Pte	2	Marketed
Mar 29, 2016	FayosimANDA 205943	Lupin	0	Discontinued
Sep 23, 2016	AyunaANDA 206866	Aurobindo Pharma	6	Marketed
Nov 14, 2016	AfirmelleANDA 206886	Aurobindo Pharma	2	Marketed
Apr 7, 2017	SimpesseANDA 206851	Aurobindo Pharma	4	Marketed
Apr 28, 2017	Lo SimpesseANDA 206852	Aurobindo Pharma	1	Marketed
Oct 2, 2017	Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolANDA 206053	Xiromed	2	Marketed
Dec 14, 2017	Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolANDA 205131	Xiromed	3	Marketed
Dec 27, 2017	JaimiessANDA 203770	Xiromed	2	Marketed
Jan 9, 2018	BalcoltraNDA 208612 · New dosage form	Avion Pharms	1	Marketed
Mar 23, 2018	Levonorgestrel And Ethinyl EstradiolANDA 202970	Xiromed	3	Discontinued
Jun 29, 2018	IcleviaANDA 206850	Aurobindo Pharma Ltd	3	Marketed
Jan 7, 2019	CerintaANDA 202817	Sun Pharm	1	Discontinued
Feb 6, 2019	SyleviaANDA 202988	Sun Pharm	0	Discontinued
Feb 14, 2020	TwirlaNDA 204017 · New dosage form	Agile	2	Marketed
Mar 30, 2020	TyblumeNDA 209405 · New dosage form	Exeltis USA Inc	2	Marketed
Aug 17, 2020	Levonorgestrel And Ethinyl EstradiolANDA 207065	Naari Pte	1	Marketed
Oct 9, 2020	Levonorgestrel And Ethinyl EstradiolANDA 207033	Naari Pte	1	Marketed
Oct 22, 2020	DolishaleANDA 91692	Novast Labs	1	Marketed
Feb 13, 2023	Levonorgestrel And Ethinyl EstradiolANDA 212298	Hetero Labs	0	Marketed
Aug 16, 2023	Levonorgestrel And Ethinyl Estradiol And Ferrous FumarateANDA 214640	Xiromed	0	Marketed
Feb 15, 2024	MinzoyaANDA 217087	Lupin	0	Marketed
—	Ethinyl Estradiol And LevonorgestrelANDA 91690	Novast Labs	0	Discontinued
—	Ethinyl Estradiol; LevonorgestrelANDA 206201	Mayne Pharma Inc	0	Discontinued

Show all 78

Complete Response Letters

FDA's published letters for these applications


Dec 21, 2017	Levonorgestrel/ethinyl estradiolProduct Quality, Clinical, Prea Requirements	Approved
Jul 17, 2013	NDA 204017Clinical, Chemistry, Manufacturing And Controls (Cmc), Path Forward	Approved
Feb 13, 2013	NDA 204017Clinical, Product Quality, Labeling	Approved

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