Drospirenone; Ethinyl Estradiol

Sold as Yasmin, Yaz. Every FDA application for this active ingredient: 4 branded and 25 generic.

As of Nov 15, 2026, FDA lists 29 applications for Drospirenone; Ethinyl Estradiol (sold as Yasmin, Yaz), first approved May 11, 2001, with 3 new uses approved and 0 published complete response letters.

First approved: May 11, 2001
Applications: 29
New uses approved: 3
Complete response letters: 0

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

YASMIN 28 TABLET: $4.39 per unitBrand · 0% in a year
YAZ 28 TABLET: $5.85 per unitBrand · 0% in a year

Clinical Trials

8 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
Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSIPoor Ovarian Reserve, Infertility (IVF Patients) · Ahmed Saad	Phase 1 / Phase 2	Not yet recruiting	Jul 30, 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 Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced MalignanciesAdvanced Malignancies · Novartis Pharmaceuticals	Phase 1	Recruiting	Jan 14, 2026
Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOSPolycystic Ovary Syndrome (PCOS) · Ege University	Not applicable	Recruiting	Nov 21, 2025
Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational StudyCardiovascular System Diseases (&Amp; [Cardiac]) · Ospedale Policlinico San Martino	—	Recruiting	Jul 11, 2025
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
International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety StudyContraception, Birth Control · Center for Epidemiology and Health Research, Germany	—	Recruiting	Sep 8, 2023

Applications

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


May 11, 2001	YasminNDA 21098 · New molecular entity, new combination	Bayer Hlthcare	17	Marketed
Mar 16, 2006	YazNDA 21676 · New active ingredient	Bayer Hlthcare	12	Marketed
Oct 4, 2006	YazNDA 21873 · TYPE 6	Bayer Hlthcare	0	Marketed
Jan 26, 2007	YazNDA 22045 · TYPE 6	Bayer Hlthcare	0	Marketed
May 9, 2008	Drospirenone And Ethinyl EstradiolANDA 77527	Barr	3	Discontinued
Mar 30, 2009	Drospirenone And Ethinyl EstradiolANDA 78515	Barr	4	Discontinued
Sep 7, 2010	Drospirenone And Ethinyl EstradiolANDA 90081	Dr Reddys Labs SA	4	Marketed
Mar 28, 2011	LorynaANDA 79221	Xiromed	6	Marketed
Mar 28, 2011	SyedaANDA 90114	Xiromed	6	Marketed
Nov 28, 2011	Drospirenone And Ethinyl EstradiolANDA 78833	Watson Labs	4	Marketed
Dec 18, 2012	Drospirenone And Ethinyl EstradiolANDA 201663	Lupin Ltd	4	Marketed
May 27, 2014	NikkiANDA 201661	Lupin	7	Marketed
Nov 19, 2014	YaelaANDA 202015	Novast Labs	3	Marketed
May 4, 2015	Drospirenone And Ethinyl EstradiolANDA 202131	Xiromed	5	Marketed
Aug 17, 2015	Drospirenone And Ethinyl EstradiolANDA 204296	Glenmark Pharms Ltd	3	Marketed
Oct 22, 2015	Drospirenone And Ethinyl EstradiolANDA 202594	Xiromed	3	Marketed
Jan 26, 2016	MelamisaANDA 202016	Novast Labs	3	Marketed
Mar 25, 2016	Drospirenone And Ethinyl EstradiolANDA 204848	Glenmark Pharms Ltd	3	Marketed
Sep 21, 2016	Drospirenone And Ethinyl EstradiolANDA 205876	Apotex	3	Discontinued
Nov 22, 2016	Drospirenone And Ethinyl EstradiolANDA 207245	Naari Pte	2	Marketed
Jul 18, 2017	Drospirenone And Ethinyl EstradiolANDA 203291	Pharmobedient	1	Marketed
Dec 22, 2017	Drospirenone And Ethinyl EstradiolANDA 209423	Jubilant Cadista	0	Discontinued
Feb 27, 2018	Lo-ZumandimineANDA 209632	Aurobindo Pharma Ltd	2	Marketed
Mar 26, 2018	ZumandimineANDA 209407	Aurobindo Pharma Ltd	2	Marketed
Sep 10, 2018	Drospirenone And Ethinyl EstradiolANDA 210017	Jubilant Cadista	0	Discontinued
Mar 13, 2019	KemeyaANDA 202138	Sun Pharm	0	Discontinued
Mar 22, 2019	Drospirenone And Ethinyl EstradiolANDA 211944	Hetero Labs	2	Marketed
Jul 23, 2019	KyraANDA 202318	Sun Pharm	0	Discontinued
Jan 24, 2020	Drospirenone And Ethinyl EstradiolANDA 213034	Hetero Labs	2	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