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FDA Orange Book · active-ingredient family

Drospirenone; ethinyl estradiol

Drospirenone; ethinyl estradiol is approved as 2 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:YAZ · NDA 021676

2

Brand (NDA)

25

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
YAZRLDBAYER HLTHCARENDA 021676ABMar 16, 2006
YASMINRLDBAYER HLTHCARENDA 021098ABMay 11, 2001

Generic (ANDA) products (25)

ProductApplicantApplicationTEApproved
DROSPIRENONE AND ETHINYL ESTRADIOLHETERO LABSANDA 213034ABJan 24, 2020
KYRASUN PHARMANDA 202318—Jul 23, 2019
DROSPIRENONE AND ETHINYL ESTRADIOLHETERO LABSANDA 211944ABMar 22, 2019
KEMEYASUN PHARMANDA 202138—Mar 13, 2019
DROSPIRENONE AND ETHINYL ESTRADIOLJUBILANT CADISTAANDA 210017—Sep 10, 2018
ZUMANDIMINEAUROBINDO PHARMA LTDANDA 209407ABMar 26, 2018
LO-ZUMANDIMINEAUROBINDO PHARMA LTDANDA 209632ABFeb 27, 2018
DROSPIRENONE AND ETHINYL ESTRADIOLJUBILANT CADISTAANDA 209423—Dec 22, 2017
DROSPIRENONE AND ETHINYL ESTRADIOLPHARMOBEDIENTANDA 203291ABJul 18, 2017
DROSPIRENONE AND ETHINYL ESTRADIOLNAARI PTEANDA 207245ABNov 22, 2016
DROSPIRENONE AND ETHINYL ESTRADIOLAPOTEXANDA 205876—Sep 21, 2016
DROSPIRENONE AND ETHINYL ESTRADIOLGLENMARK PHARMS LTDANDA 204848ABMar 25, 2016
MELAMISANOVAST LABSANDA 202016ABJan 26, 2016
DROSPIRENONE AND ETHINYL ESTRADIOLXIROMEDANDA 202594ABOct 22, 2015
DROSPIRENONE AND ETHINYL ESTRADIOLGLENMARK PHARMS LTDANDA 204296ABAug 17, 2015
DROSPIRENONE AND ETHINYL ESTRADIOLXIROMEDANDA 202131ABMay 04, 2015
YAELANOVAST LABSANDA 202015ABNov 19, 2014
NIKKILUPINANDA 201661ABMay 27, 2014
DROSPIRENONE AND ETHINYL ESTRADIOLLUPIN LTDANDA 201663ABDec 18, 2012
DROSPIRENONE AND ETHINYL ESTRADIOLWATSON LABSANDA 078833ABNov 28, 2011
LORYNAXIROMEDANDA 079221ABMar 28, 2011
SYEDAXIROMEDANDA 090114ABMar 28, 2011
DROSPIRENONE AND ETHINYL ESTRADIOLDR REDDYS LABS SAANDA 090081ABSep 07, 2010
DROSPIRENONE AND ETHINYL ESTRADIOLBARRANDA 078515—Mar 30, 2009
DROSPIRENONE AND ETHINYL ESTRADIOLBARRANDA 077527—May 09, 2008

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Drospirenone; ethinyl estradiol — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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