Assyro AI

FDA Orange Book · active-ingredient family

Ethinyl estradiol; norethindrone

Ethinyl estradiol; norethindrone is approved as 17 brand and 59 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE · NDA 022573

17

Brand (NDA)

59

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, tablet, chewable

ProductApplicantApplicationTEApproved
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATERLDTEVA BRANDED PHARMNDA 022573—Dec 22, 2010
FEMCON FERLDAPILNDA 021490—Nov 14, 2003
TRI-NORINYL 28-DAYRLD×2DR REDDYS LABS SANDA 018977ABApr 13, 1984
ORTHO-NOVUM 7/7/7-28RLD×2JANSSEN PHARMSNDA 018985—Apr 04, 1984
ORTHO-NOVUM 10/11-21RLD×2ORTHO MCNEIL JANSSENNDA 018354—Jan 11, 1982
OVCON-35RLDWARNER CHILCOTTNDA 018127—Approved Prior to Jan 1, 1982
MODICON 28RLDJANSSEN PHARMSNDA 017735—Approved Prior to Jan 1, 1982
ORTHO-NOVUM 1/35-28RLDJANSSEN PHARMSNDA 017919—Approved Prior to Jan 1, 1982
OVCON-35RLDWARNER CHILCOTT LLCNDA 017716—Approved Prior to Jan 1, 1982
ORTHO-NOVUM 7/14-21×2ORTHO MCNEIL PHARMNDA 019004—Apr 04, 1984
BREVICON 21-DAYALLERGANNDA 017566—Approved Prior to Jan 1, 1982
MODICON 21ORTHO MCNEIL PHARMNDA 017488—Approved Prior to Jan 1, 1982
NORINYL 1+35 21-DAY×2ALLERGANNDA 017565—Approved Prior to Jan 1, 1982
ORTHO-NOVUM 1/35-21ORTHO MCNEIL PHARMNDA 017489—Approved Prior to Jan 1, 1982
OVCON-50WARNER CHILCOTTNDA 018128—Approved Prior to Jan 1, 1982
BREVICON 28-DAYALLERGANNDA 017743—Approved Prior to Jan 1, 1982
OVCON-50WARNER CHILCOTT LLCNDA 017576—Approved Prior to Jan 1, 1982

Generic (ANDA) products (59)

ProductApplicantApplicationTEApproved
RHUZDAHAUROBINDO PHARMAANDA 207585—Oct 11, 2022
NORETHINDRONE AND ETHINYL ESTRADIOLNAARI PTEANDA 206864ABApr 28, 2017
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATENAARI PTEANDA 207066ABMar 29, 2017
NEXESTA FEAUROBINDO PHARMAANDA 207535ABFeb 02, 2017
CYONANZAUROBINDO PHARMAANDA 207055ABOct 21, 2016
NYLIA 1/35AUROBINDO PHARMAANDA 207056ABOct 21, 2016
NYLIA 7/7/7AUROBINDO PHARMAANDA 207054ABOct 21, 2016
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATELUPINANDA 091332ABMar 23, 2016
NORETHINDRONE AND ETHINYL ESTRADIOLMYLAN LABS LTDANDA 200486—Dec 28, 2015
KAITLIB FELUPINANDA 203448ABDec 17, 2015
CYCLAFEM 0.5/35PH HEALTHANDA 203413—Dec 16, 2015
NORETHINDRONE AND ETHINYL ESTRADIOLMYLAN LABS LTDANDA 200488—Oct 21, 2015
NORETHINDRONE AND ETHINYL ESTRADIOLMYLAN LABS LTDANDA 200489—Oct 21, 2015
NORETHINDRONE AND ETHINYL ESTRADIOLXIROMEDANDA 200897—May 11, 2015
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXIROMEDANDA 202086ABApr 01, 2015
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXIROMEDANDA 203371ABApr 23, 2014
VYFEMLALUPINANDA 201886ABSep 26, 2013
NORETHINDRONE AND ETHINYL ESTRADIOLXIROMEDANDA 203006—Aug 05, 2013
PIRMELLA 1/35LUPIN LTDANDA 201512—Apr 24, 2013
PIRMELLA 7/7/7LUPIN LTDANDA 201510—Apr 24, 2013
GILDAGIAPH HEALTHANDA 078376—Nov 06, 2012
WERANOVAST LABS LTDANDA 091204ABMar 27, 2012
ALYACEN 1/35GLENMARK PHARMS LTDANDA 091634ABJan 19, 2012
ALYACEN 7/7/7GLENMARK PHARMS LTDANDA 091636ABJan 19, 2012
DASETTA 1/35NOVAST LABS LTDANDA 090948ABDec 22, 2011
DASETTA 7/7/7NOVAST LABS LTDANDA 090946ABDec 22, 2011
PHILITHNOVAST LABS LTDANDA 090947ABDec 22, 2011
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAMNEAL PHARMSANDA 078892ABSep 26, 2011
BRIELLYNGLENMARK PHARMS LTDANDA 090538ABMar 22, 2011
CYCLAFEM 7/7/7PH HEALTHANDA 076338—Nov 16, 2010
CYCLAFEM 1/35PH HEALTHANDA 076337—Nov 12, 2010
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEBARRANDA 078965ABAug 05, 2010
NORETHINDRONE AND ETHINYL ESTRADIOLWATSON LABSANDA 078379—Feb 23, 2010
NORETHINDRONE AND ETHINYL ESTRADIOLWATSON LABSANDA 078323ABFeb 04, 2010
NORETHINDRONE AND ETHINYL ESTRADIOLWATSON LABSANDA 076393—Feb 04, 2010
ARANELLEBARRANDA 076783ABSep 29, 2004
BALZIVA-21BARRANDA 076198—Apr 22, 2004
BALZIVA-28BARRANDA 076238ABApr 22, 2004
NORTREL 7/7/7×2BARRANDA 075478—Aug 30, 2002
GENCEPT 10/11-21BARRANDA 072694—Feb 28, 1992
NORTREL 0.5/35-21BARRANDA 072692—Feb 28, 1992
NORTREL 1/35-21BARRANDA 072693ABFeb 28, 1992
GENCEPT 10/11-28BARR LABSANDA 072697—Feb 28, 1992
NORTREL 0.5/35-28BARR LABSANDA 072695ABFeb 28, 1992
NORTREL 1/35-28BARR LABSANDA 072696ABFeb 28, 1992
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)WATSON LABS TEVAANDA 071041—Sep 24, 1991
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)WATSON LABSANDA 071042—Sep 24, 1991
NORCEPT-E 1/35 21ORTHO MCNEIL PHARMANDA 071545—Feb 09, 1989
NORCEPT-E 1/35 28ORTHO MCNEIL PHARMANDA 071546—Feb 09, 1989
NORETHIN 1/35E-21WATSON PHARMS TEVAANDA 071480—Apr 12, 1988
NORETHIN 1/35E-28WATSON LABSANDA 071481—Apr 12, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)WATSON LABSANDA 071043—Apr 01, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)WATSON LABS TEVAANDA 071044—Apr 01, 1988
N.E.E. 1/35 21LPIANDA 071541—Dec 14, 1987
N.E.E. 1/35 28LPIANDA 071542—Dec 14, 1987
NORETHINDRONE AND ETHINYL ESTRADIOLWATSON LABSANDA 070684—Jan 29, 1987
NORETHINDRONE AND ETHINYL ESTRADIOLWATSON PHARMS TEVAANDA 070685—Jan 29, 1987
NORETHINDRONE AND ETHINYL ESTRADIOLDR REDDYS LABS SAANDA 070686—Jan 29, 1987
NORETHINDRONE AND ETHINYL ESTRADIOLWATSON LABS TEVAANDA 070687ABJan 29, 1987

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; norethindrone — frequently asked questions

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

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