FDA — authorised 4 October 2006
- Application: NDA021873
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: YAZ
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Drospirenone and ethinyl estradiol in United States
FDA authorised Drospirenone and ethinyl estradiol on 4 October 2006 · 8,820 US adverse-event reports
Marketing authorisations
FDA — authorised 9 May 2008
- Application: ANDA077527
- Marketing authorisation holder: BARR
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 March 2009
- Application: ANDA078515
- Marketing authorisation holder: BARR
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 September 2010
- Application: ANDA090081
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 November 2011
- Application: ANDA078833
- Marketing authorisation holder: WATSON LABS
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 December 2012
- Application: ANDA201663
- Marketing authorisation holder: LUPIN LTD
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 4 May 2015
- Application: ANDA202131
- Marketing authorisation holder: XIROMED
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 17 August 2015
- Application: ANDA204296
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 22 October 2015
- Application: ANDA202594
- Marketing authorisation holder: XIROMED
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 2016
- Application: ANDA204848
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 September 2016
- Application: ANDA205876
- Marketing authorisation holder: APOTEX
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 November 2016
- Application: ANDA207245
- Marketing authorisation holder: NAARI PTE
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 18 July 2017
- Application: ANDA203291
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2017
- Application: ANDA209423
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2018
- Application: ANDA209632
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: supplemented
FDA — authorised 10 September 2018
- Application: ANDA210017
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 March 2019
- Application: ANDA211944
- Marketing authorisation holder: HETERO LABS
- Status: supplemented
FDA — authorised 24 January 2020
- Application: ANDA213034
- Marketing authorisation holder: HETERO LABS
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 8,820
Most-reported reactions
- Pain — 1,721 reports (19.51%)
- Injury — 1,304 reports (14.78%)
- Cholecystitis Chronic — 1,032 reports (11.7%)
- Anxiety — 783 reports (8.88%)
- Gallbladder Disorder — 776 reports (8.8%)
- Pulmonary Embolism — 765 reports (8.67%)
- Deep Vein Thrombosis — 718 reports (8.14%)
- Emotional Distress — 692 reports (7.85%)
- Cholelithiasis — 674 reports (7.64%)
- Abdominal Pain — 355 reports (4.02%)
Drospirenone and ethinyl estradiol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Drospirenone and ethinyl estradiol approved in United States?
Yes. FDA authorised it on 4 October 2006; FDA authorised it on 9 May 2008; FDA authorised it on 30 March 2009.
Who is the marketing authorisation holder for Drospirenone and ethinyl estradiol in United States?
BAYER HLTHCARE holds the US marketing authorisation.