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FDA Orange Book · active-ingredient family

Ethinyl estradiol; norgestimate

Ethinyl estradiol; norgestimate is approved as 3 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ORTHO TRI-CYCLEN LO · NDA 021241

3

Brand (NDA)

31

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ORTHO TRI-CYCLEN LORLDJANSSEN PHARMSNDA 021241—Aug 22, 2002
ORTHO TRI-CYCLENRLD×2JANSSEN PHARMSNDA 019697—Jul 03, 1992
ORTHO CYCLEN-28RLD×2JANSSEN PHARMSNDA 019653—Dec 29, 1989

Generic (ANDA) products (31)

ProductApplicantApplicationTEApproved
TRI-LO-LINYAHNOVAST LABSANDA 090541ABSep 02, 2022
TRI-LO-MILIAUROBINDO PHARMAANDA 205762ABNov 04, 2016
NORGESTIMATE AND ETHINYL ESTRADIOLLUPINANDA 205630ABOct 27, 2016
MILIAUROBINDO PHARMA LTDANDA 205449ABJul 07, 2016
TRI-MILIAUROBINDO PHARMA LTDANDA 205441ABJul 06, 2016
NORGESTIMATE AND ETHINYL ESTRADIOLNAARI PTEANDA 203873ABMay 12, 2016
NORGESTIMATE AND ETHINYL ESTRADIOLLUPINANDA 205588ABApr 26, 2016
NORGESTIMATE AND ETHINYL ESTRADIOLGLENMARK SPECLTANDA 204057ABFeb 23, 2016
NORGESTIMATE AND ETHINYL ESTRADIOLMYLANANDA 201896—Jan 27, 2016
NORGESTIMATE AND ETHINYL ESTRADIOLXIROMEDANDA 201897—Jan 27, 2016
NORGESTIMATE AND ETHINYL ESTRADIOLNAARI PTEANDA 203870—Nov 12, 2015
NORGESTIMATE AND ETHINYL ESTRADIOLNAARI PTEANDA 203865—Oct 27, 2015
NORGESTIMATE AND ETHINYL ESTRADIOLXIROMEDANDA 202132—Sep 09, 2015
TRI-LO-ESTARYLLAXIROMEDANDA 091232ABJun 29, 2015
NORGESTIMATE AND ETHINYL ESTRADIOLNAARI PTEANDA 200383ABApr 07, 2015
NORGESTIMATE AND ETHINYL ESTRADIOLNAARI PTEANDA 200384ABApr 07, 2015
ESTARYLLAXIROMEDANDA 090794ABJan 30, 2013
TRI-ESTARYLLAXIROMEDANDA 090793ABJan 30, 2013
NORGESTIMATE AND ETHINYL ESTRADIOLLUPIN PHARMSANDA 200541ABJun 25, 2012
TRI-LINYAHNOVAST LABS LTDANDA 090524ABMay 30, 2012
MONO-LINYAHNOVAST LABS LTDANDA 090523ABMay 23, 2012
NORGESTIMATE AND ETHINYL ESTRADIOLGLENMARK PHARMS LTDANDA 200538ABApr 05, 2012
NORGESTIMATE AND ETHINYL ESTRADIOLGLENMARK PHARMS LTDANDA 200494ABJun 17, 2011
NORGESTIMATE AND ETHINYL ESTRADIOLWATSON LABSANDA 090479—Mar 09, 2011
TRI LO SPRINTECBARR LABS INCANDA 076784ABJun 29, 2009
NORGESTIMATE AND ETHINYL ESTRADIOLWATSON LABSANDA 076626—Aug 17, 2006
NORGESTIMATE AND ETHINYL ESTRADIOLWATSON LABSANDA 076627—Aug 17, 2006
TRI-PREVIFEMPH HEALTHANDA 076335—Mar 26, 2004
PREVIFEMPH HEALTHANDA 076334—Jan 09, 2004
TRI-SPRINTECBARRANDA 075808ABDec 29, 2003
SPRINTECBARRANDA 075804ABSep 25, 2002

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.

Ethinyl estradiol; norgestimate — frequently asked questions

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

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