Ethinyl Estradiol / Norethindrone Oral Tablet

Brand(s)
Femhrt, Jevantique, Jinteli
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2015-11-19)
Oldest Current Product
1977-06-23
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ETHINYL ESTRADIOL:NORETHINDRONE
FDAOB
ORAL-21\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE ACETATE\rdfq
ORAL-21\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE\rdfq
ORAL-28\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE ACETATE\rdfq
ORAL-28\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE\rdfq
ORAL\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE ACETATE
SPL Active
ORAL\TABLET, FILM COATED\ETHINYL ESTRADIOL: NORETHINDRONE ACETATE
ORAL\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE
ORAL\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE ACETATE
SPL Moiety
ORAL\TABLET, FILM COATED\ETHINYL ESTRADIOL: NORETHINDRONE
ORAL\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE

product(s) by strength(s)

ethinyl estradiol 0.0025 mg / norethindrone acetate 0.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440236JevantiqueNDAActavis Pharma, Inc.2015-11-09ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETNDA0210656b08d806-eb1f-4b25-9995-ae8321a6ff78

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1684620656ANDAGlenmark Generics Inc., Usa2015-04-02ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETANDA203038cf549b5a-2707-4020-9f94-dab1260e1664

ethinyl estradiol 0.005 mg / norethindrone acetate 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004300544FemhrtNDAWarner Chilcott (Us), Llc2009-11-012012-08-01ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETNDA0210650fece0aa-2b9c-40a3-975e-1ef2c2ef72f2

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933122JinteliANDATeva Pharmaceuticals Usa Inc2011-02-17ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETANDA076221d667ca75-1a17-43fc-9077-f25ce0908f8d
2684620657ANDAGlenmark Generics Inc., Usa2015-04-02ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETANDA203038cf549b5a-2707-4020-9f94-dab1260e1664

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686251JinteliANDAPhysicians Total Care, Inc.2011-04-26ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLET000933122ANDA076221e6634d24-08af-44bc-8e76-e759619857fa

ethinyl estradiol 0.02 mg / norethindrone acetate 1 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935328ANDATeva Pharmaceuticals Usa Inc2015-05-29ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETANDA090938ffbf48de-0f61-49f9-9cd5-6eb8e08040db
2003787301ANDAMylan Pharmaceuticals Inc.2014-10-30ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETANDA2027426fffc464-16c9-4a80-9b2b-1165395ca9d8
3006037609ANDAQualitest Pharmaceuticals2005-05-20ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLET, FILM COATEDANDA077077cffba5ad-771c-4b14-9f8a-9155ca383ccb
4006037610ANDAQualitest Pharmaceuticals2014-12-01ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLET, FILM COATEDANDA0902935ac5f3af-8cd8-4a96-88e6-3a8f820c17f2

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440167NDAActavis Pharma, Inc.2015-11-05ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETNDA021871553fcd4d-f144-445f-8b41-0c33f4350a4a

ethinyl estradiol 0.03 mg / norethindrone acetate 1.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006037608ANDAQualitest Pharmaceuticals2005-04-28ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLET, FILM COATEDANDA077075c6cfea6d-8a9d-4d4a-8e8c-d496c618efd0

ethinyl estradiol 0.035 mg / norethindrone 0.4 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006033590ANDAQualitest Pharmaceuticals2012-12-23ETHINYL ESTRADIOL, NORETHINDRONEORALTABLETANDA078376d5fcf844-2915-4c0c-b41a-9510dc0df5e5
2681800875ANDALupin Pharmaceuticals, Inc.2013-12-23ETHINYL ESTRADIOL, NORETHINDRONEORALTABLETANDA201886e94c80c9-fec0-42ba-8fce-dc993cb18e6a

ethinyl estradiol 0.035 mg / norethindrone 0.5 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580171NDAJanssen Pharmaceuticals, Inc.1984-04-04ETHINYL ESTRADIOL, NORETHINDRONEORALTABLETNDA0189852524b253-069e-4028-819c-361b888df110

ethinyl estradiol 0.035 mg / norethindrone 1 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580176NDAJanssen Pharmaceuticals, Inc.1977-06-23ETHINYL ESTRADIOL, NORETHINDRONEORALTABLETNDA0179192524b253-069e-4028-819c-361b888df110

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681800893ANDALupin Pharmaceuticals, Inc.2013-06-21ETHINYL ESTRADIOL, NORETHINDRONEORALTABLETANDA201512bb21b098-284a-4cad-bf8f-a062e88a3d56

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA070684NORETHINDRONE AND ETHINYL ESTRADIOLTrueWATSON LABORATORIES INC1987-01-29ANDA070684_001
2ANDA070685NORETHINDRONE AND ETHINYL ESTRADIOLTrueWATSON LABORATORIES INC1987-01-29ANDA070685_001
3ANDA070686NORETHINDRONE AND ETHINYL ESTRADIOLWATSON LABORATORIES INC1987-01-29ANDA070686_001
4ANDA070687NORETHINDRONE AND ETHINYL ESTRADIOLWATSON LABORATORIES INC1987-01-29ANDA070687_001
5ANDA071041NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)TrueWATSON LABORATORIES INC1991-09-24ANDA071041_001
6ANDA071042NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)TrueWATSON LABORATORIES INC1991-09-24ANDA071042_001
7ANDA071043NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)TrueWATSON LABORATORIES INC1988-04-01ANDA071043_001
8ANDA071044NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)WATSON LABORATORIES INC1988-04-01ANDA071044_001
9ANDA071480NORETHIN 1/35E-21TrueWATSON LABORATORIES INC1988-04-12ANDA071480_001
10ANDA071481NORETHIN 1/35E-28TrueWATSON LABORATORIES INC1988-04-12ANDA071481_001
11ANDA071541N.E.E. 1/35 21TrueLPI HOLDINGS INC1987-12-14ANDA071541_001
12ANDA071542N.E.E. 1/35 28TrueLPI HOLDINGS INC1987-12-14ANDA071542_001
13ANDA071545NORCEPT-E 1/35 21TrueORTHO MCNEIL PHARMACEUTICAL INC1989-02-09ANDA071545_001
14ANDA071546NORCEPT-E 1/35 28TrueORTHO MCNEIL PHARMACEUTICAL INC1989-02-09ANDA071546_001
15ANDA072692NORTREL 0.5/35-21TrueBARR LABORATORIES INC1992-02-28ANDA072692_001
16ANDA072693NORTREL 1/35-21BARR LABORATORIES INC1992-02-28ANDA072693_001
17ANDA072694GENCEPT 10/11-21TrueBARR LABORATORIES INC1992-02-28ANDA072694_001
18ANDA072695NORTREL 0.5/35-28BARR LABORATORIES INC1992-02-28ANDA072695_001
19ANDA072696NORTREL 1/35-28BARR LABORATORIES INC1992-02-28ANDA072696_001
20ANDA072697GENCEPT 10/11-28TrueBARR LABORATORIES INC1992-02-28ANDA072697_001
21ANDA075478NORTREL 7/7/7BARR LABORATORIES INC2002-08-30ANDA075478_001, ANDA075478_002
22ANDA075548MICROGESTIN 1.5/30WATSON LABORATORIES2001-02-05ANDA075548_001, ANDA075548_002
23ANDA075647MICROGESTIN 1/20WATSON LABORATORIES2001-02-05ANDA075647_001, ANDA075647_002
24ANDA076064JUNEL FE 1.5/30BARR LABORATORIES INC2003-09-18ANDA076064_001
25ANDA076081JUNEL FE 1/20BARR LABORATORIES INC2003-09-18ANDA076081_001
26ANDA076105TRI-LEGEST FEBARR LABORATORIES INC2007-10-26ANDA076105_001
27ANDA076198BALZIVA-21TrueBARR LABORATORIES INC2004-04-22ANDA076198_001
28ANDA076221NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLBARR LABORATORIES INC2009-11-06ANDA076221_001Ethinyl Estradiol Oral Tablet
29ANDA076238BALZIVA-28BARR LABORATORIES INC2004-04-22ANDA076238_001
30ANDA076337CYCLAFEM 1/35VINTAGE PHARMACEUTICALS LLC2010-11-12ANDA076337_001
31ANDA076338CYCLAFEM 7/7/7VINTAGE PHARMACEUTICALS LLC2010-11-16ANDA076338_001
32ANDA076380JUNEL 1/20BARR LABORATORIES INC2003-05-30ANDA076380_001
33ANDA076381JUNEL 1.5/30BARR LABORATORIES INC2003-05-30ANDA076381_001
34ANDA076393NORETHINDRONE AND ETHINYL ESTRADIOLTrueWATSON LABORATORIES INC2010-02-04ANDA076393_001
35ANDA076405TRI-LEGEST 21BARR LABORATORIES INC2007-10-26ANDA076405_001
36ANDA076629NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLWATSON LABORATORIES2010-03-18ANDA076629_001
37ANDA076783ARANELLEBARR LABORATORIES INC2004-09-29ANDA076783_001
38ANDA077075GILDESS 1.5/30VINTAGE PHARMACEUTICALS LLC2005-04-28ANDA077075_001, ANDA077075_002
39ANDA077077GILDESS 1/20VINTAGE PHARMACEUTICALS LLC2005-05-20ANDA077077_001, ANDA077077_002
40ANDA078267NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAMNEAL PHARMACEUTICALS OF NEW YORK LLC2009-09-01ANDA078267_001Ethinyl Estradiol Oral Tablet
41ANDA078323NORETHINDRONE AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2010-02-04ANDA078323_001
42ANDA078376GILDAGIAVINTAGE PHARMACEUTICALS2012-11-06ANDA078376_001
43ANDA078379NORETHINDRONE AND ETHINYL ESTRADIOLTrueWATSON LABORATORIES INC2010-02-23ANDA078379_001
44ANDA090293GILDESS 24 FEVINTAGE PHARMACEUTICALS2014-12-01ANDA090293_001Ethinyl Estradiol Oral Tablet
45ANDA090538BRIELLYNGLENMARK GENERICS LIMITED2011-03-22ANDA090538_001
46ANDA090938NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEBARR LABORATORIES INC2014-12-01ANDA090938_001Ethinyl Estradiol Oral Tablet
47ANDA090946DASETTA 7/7/7NOVAST LABORATORIES LTD2011-12-22ANDA090946_001
48ANDA090947PHILITHNOVAST LABORATORIES LTD2011-12-22ANDA090947_001
49ANDA090948DASETTA 1/35NOVAST LABORATORIES LTD2011-12-22ANDA090948_001
50ANDA091204WERANOVAST LABORATORIES LTD2012-03-27ANDA091204_001
51ANDA091398BLISOVI 24 FELUPIN LTD2015-10-28ANDA091398_001Ethinyl Estradiol Oral Tablet
52ANDA091453LARIN FE 1.5/30NOVAST LABORATORIES LTD2013-08-23ANDA091453_001
53ANDA091454LARIN FE 1/20NOVAST LABORATORIES LTD2013-08-26ANDA091454_001
54ANDA091634ALYACEN 1/35GLENMARK GENERICS LTD2012-01-19ANDA091634_001
55ANDA091636ALYACEN 7/7/7GLENMARK GENERICS LTD2012-01-19ANDA091636_001
56ANDA200488NORETHINDRONE AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-10-21ANDA200488_001
57ANDA200489NORETHINDRONE AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-10-21ANDA200489_001
58ANDA200897NORETHINDRONE AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-05-11ANDA200897_001
59ANDA201510PIRMELLA 7/7/7LUPIN LTD2013-04-24ANDA201510_001
60ANDA201512PIRMELLA 1/35LUPIN LTD2013-04-24ANDA201512_001
61ANDA201886VYFEMLALUPIN LTD2013-09-26ANDA201886_001
62ANDA202741NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-02-20ANDA202741_001
63ANDA202742NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEJAI PHARMA LTD2014-10-30ANDA202742_001Ethinyl Estradiol Oral Tablet
64ANDA202770NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-02-19ANDA202770_001
65ANDA202771NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLJAI PHARMA LTD2013-11-06ANDA202771_001
66ANDA202772NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLJAI PHARMA LTD2013-11-14ANDA202772_001
67ANDA202994LARIN 24 FENOVAST LABORATORIES LTD2015-02-18ANDA202994_001Ethinyl Estradiol Oral Tablet
68ANDA202995LARIN 1/20NOVAST LABORATORIES LTD2013-12-04ANDA202995_001
69ANDA202996LARIN 1.5/30NOVAST LABORATORIES LTD2014-03-20ANDA202996_001
70ANDA203006NORETHINDRONE AND ETHINYL ESTRADIOLJAI PHARMA LTD2013-08-05ANDA203006_001
71ANDA203038NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGLENMARK GENERICS LTD2015-04-02ANDA203038_001, ANDA203038_002Ethinyl Estradiol Oral Tablet
72NDA016723NORLESTRIN 28 1/50TruePARKE DAVIS LABORATORIES DIV WARNER LAMBERT CONDA016723_001
73NDA016749NORLESTRIN 21 1/50TruePARKE DAVIS LABORATORIES DIV WARNER LAMBERT CONDA016749_001
74NDA016852NORLESTRIN 21 2.5/50TruePARKE DAVIS LABORATORIES DIV WARNER LAMBERT CONDA016852_001
75NDA017354LOESTRIN FE 1/20WARNER CHILCOTT INCNDA017354_001
76NDA017355LOESTRIN FE 1.5/30WARNER CHILCOTT CO LLCNDA017355_001
77NDA017488MODICON 21TrueORTHO MCNEIL PHARMACEUTICAL INCNDA017488_001
78NDA017489ORTHO-NOVUM 1/35-21TrueORTHO MCNEIL PHARMACEUTICAL INCNDA017489_002
79NDA017565NORINYL 1+35 21-DAYACTAVIS LABORATORIES UT INCNDA017565_001, NDA017565_002
80NDA017566BREVICON 21-DAYTrueACTAVIS LABORATORIES UT INCNDA017566_001
81NDA017576OVCON-50TrueWARNER CHILCOTT CO LLCNDA017576_001
82NDA017716OVCON-35TrueWARNER CHILCOTT CO LLCNDA017716_001
83NDA017735MODICON 28JANSSEN PHARMACEUTICALS INCNDA017735_001
84NDA017743BREVICON 28-DAYACTAVIS LABORATORIES UT INCNDA017743_001
85NDA017875LOESTRIN 21 1.5/30WARNER CHILCOTT CO LLCNDA017875_001
86NDA017876LOESTRIN 21 1/20WARNER CHILCOTT CO LLCNDA017876_001
87NDA017919ORTHO-NOVUM 1/35-28JANSSEN PHARMACEUTICALS INCNDA017919_002
88NDA018127OVCON-35TrueWARNER CHILCOTT INCNDA018127_001
89NDA018128OVCON-50TrueWARNER CHILCOTT INCNDA018128_001
90NDA018354ORTHO-NOVUM 10/11-21TrueORTHO MCNEIL JANSSEN PHARMACEUTICALS INC1982-01-11NDA018354_001, NDA018354_002
91NDA018977TRI-NORINYL 21-DAYACTAVIS LABORATORIES UT INC1984-04-13NDA018977_001, NDA018977_002
92NDA018985ORTHO-NOVUM 7/7/7-21JANSSEN PHARMACEUTICALS INC1984-04-04NDA018985_001, NDA018985_002
93NDA019004ORTHO-NOVUM 7/14-21TrueORTHO MCNEIL PHARMACEUTICAL INC1984-04-04NDA019004_001, NDA019004_002
94NDA020130ESTROSTEP 21WARNER CHILCOTT CO LLC1996-10-09NDA020130_001, NDA020130_002
95NDA021065FEMHRTWARNER CHILCOTT CO LLC1999-10-15NDA021065_001, NDA021065_002Ethinyl Estradiol Oral Tablet
96NDA021871LOESTRIN 24 FETrueWARNER CHILCOTT INC2006-02-17p5552394, PREVENTION OF PREGNANCYNDA021871_001Ethinyl Estradiol Oral Tablet
97NDA022501LO LOESTRIN FEWARNER CHILCOTT CO LLC2010-10-21p5552394, LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOF OF CONTRACEPTION
p7704984, LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOF OF CONTRACEPTION
NDA022501_001Ethinyl Estradiol Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070684_001discontinuedNORETHINDRONE (0.5MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalse1987-01-29NORETHINDRONE AND ETHINYL ESTRADIOL
2ANDA070685_001discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalse1987-01-29NORETHINDRONE AND ETHINYL ESTRADIOL
3ANDA070686_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (0.5MG)TABLETFalseAB1987-01-29NORETHINDRONE AND ETHINYL ESTRADIOL
4ANDA070687_001RXNORETHINDRONE (1MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB1987-01-29NORETHINDRONE AND ETHINYL ESTRADIOL
5ANDA071041_001discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG)TABLETFalse1991-09-24NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
6ANDA071042_001discontinuedNORETHINDRONE (0.5MG,1MG), ETHINYL ESTRADIOL (0.035MG,0.035MG)TABLETFalse1991-09-24NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
7ANDA071043_001discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG)TABLETFalse1988-04-01NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
8ANDA071044_001RXNORETHINDRONE (0.5MG,1MG), ETHINYL ESTRADIOL (0.035MG,0.035MG)TABLETFalse1988-04-01NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
9ANDA071480_001discontinuedNORETHINDRONE (1MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalse1988-04-12NORETHIN 1/35E-21
10ANDA071481_001discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalse1988-04-12NORETHIN 1/35E-28
11ANDA071541_001discontinuedNORETHINDRONE (1MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalse1987-12-14N.E.E. 1/35 21
12ANDA071542_001discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalse1987-12-14N.E.E. 1/35 28
13ANDA071545_001discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalse1989-02-09NORCEPT-E 1/35 21
14ANDA071546_001discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalse1989-02-09NORCEPT-E 1/35 28
15ANDA072692_001discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (0.5MG)TABLETFalse1992-02-28NORTREL 0.5/35-21
16ANDA072693_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalseAB1992-02-28NORTREL 1/35-21
17ANDA072694_001discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG)TABLETFalse1992-02-28GENCEPT 10/11-21
18ANDA072695_001RXNORETHINDRONE (0.5MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB1992-02-28NORTREL 0.5/35-28
19ANDA072696_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalseAB1992-02-28NORTREL 1/35-28
20ANDA072697_001discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG)TABLETFalse1992-02-28GENCEPT 10/11-28
21ANDA075478_001RXNORETHINDRONE (0.5MG,0.75MG,1MG), ETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG)TABLETFalse2002-08-30NORTREL 7/7/7
22ANDA075478_002RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORETHINDRONE (0.5MG,0.75MG,1MG)TABLETFalseAB2002-08-30NORTREL 7/7/7
23ANDA075548_001RXNORETHINDRONE ACETATE (1.5MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2001-02-05MICROGESTIN 1.5/30
24ANDA075548_002RXETHINYL ESTRADIOL (0.03MG), NORETHINDRONE ACETATE (1.5MG)TABLETFalseAB2003-07-30MICROGESTIN 1.5/30
25ANDA075647_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)TABLETFalseAB2001-02-05MICROGESTIN 1/20
26ANDA075647_002RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)TABLETFalseAB2003-07-30MICROGESTIN 1/20
27ANDA076064_001RXETHINYL ESTRADIOL (0.03MG), NORETHINDRONE ACETATE (1.5MG)TABLETFalseAB2003-09-18JUNEL FE 1.5/30
28ANDA076081_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)TABLETFalseAB2003-09-18JUNEL FE 1/20
29ANDA076105_001RXETHINYL ESTRADIOL (0.02MG,0.03MG,0.035MG), NORETHINDRONE ACETATE (1MG,1MG,1MG)TABLETFalseAB2007-10-26TRI-LEGEST FE
30ANDA076198_001discontinuedNORETHINDRONE (0.4MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalse2004-04-22BALZIVA-21
31ANDA076221_001RXETHINYL ESTRADIOL (0.005MG), NORETHINDRONE ACETATE (1MG)ORALTABLETTrueAB2009-11-06NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
32ANDA076238_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (0.4MG)TABLETFalseAB2004-04-22BALZIVA-28
33ANDA076337_001RXNORETHINDRONE (1MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2010-11-12CYCLAFEM 1/35
34ANDA076338_001RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORETHINDRONE (0.5MG,0.75MG,1MG)TABLETFalseAB2010-11-16CYCLAFEM 7/7/7
35ANDA076380_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB2003-05-30JUNEL 1/20
36ANDA076381_001RXETHINYL ESTRADIOL (0.03MG), NORETHINDRONE ACETATE (1.5MG)TABLETFalseAB2003-05-30JUNEL 1.5/30
37ANDA076393_001discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORETHINDRONE (0.5MG,0.75MG,1MG)TABLETFalse2010-02-04NORETHINDRONE AND ETHINYL ESTRADIOL
38ANDA076405_001RXETHINYL ESTRADIOL (0.02MG,0.03MG,0.035MG), NORETHINDRONE ACETATE (1MG,1MG,1MG)TABLETFalse2007-10-26TRI-LEGEST 21
39ANDA076629_001RXETHINYL ESTRADIOL (0.02MG,0.03MG,0.035MG), NORETHINDRONE ACETATE (1MG,1MG,1MG)TABLETFalseAB2010-03-18NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
40ANDA076783_001RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG,0.5MG)TABLETFalseAB2004-09-29ARANELLE
41ANDA077075_001RXNORETHINDRONE ACETATE (1.5MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2005-04-28GILDESS 1.5/30
42ANDA077075_002RXNORETHINDRONE ACETATE (1.5MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2012-07-24GILDESS 1.5/30
43ANDA077077_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)TABLETFalseAB2005-05-20GILDESS 1/20
44ANDA077077_002RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)TABLETFalseAB2012-07-24GILDESS 1/20
45ANDA078267_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)ORALTABLETTrueAB2009-09-01NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
46ANDA078323_001RXNORETHINDRONE (0.4MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2010-02-04NORETHINDRONE AND ETHINYL ESTRADIOL
47ANDA078376_001RXNORETHINDRONE (0.4MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2012-11-06GILDAGIA
48ANDA078379_001discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (0.4MG)TABLETFalse2010-02-23NORETHINDRONE AND ETHINYL ESTRADIOL
49ANDA090293_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)ORALTABLETFalseAB2014-12-01GILDESS 24 FE
50ANDA090538_001RXNORETHINDRONE (0.4MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2011-03-22BRIELLYN
51ANDA090938_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)ORALTABLETFalseAB2014-12-01NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
52ANDA090946_001RXNORETHINDRONE (0.5MG,0.75MG,1MG), ETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG)TABLETFalseAB2011-12-22DASETTA 7/7/7
53ANDA090947_001RXNORETHINDRONE (0.4MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2011-12-22PHILITH
54ANDA090948_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalseAB2011-12-22DASETTA 1/35
55ANDA091204_001RXNORETHINDRONE (0.5MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2012-03-27WERA
56ANDA091398_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)ORALTABLETFalseAB2015-10-28BLISOVI 24 FE
57ANDA091453_001RXETHINYL ESTRADIOL (0.03MG), NORETHINDRONE ACETATE (1.5MG)TABLETFalseAB2013-08-23LARIN FE 1.5/30
58ANDA091454_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB2013-08-26LARIN FE 1/20
59ANDA091634_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalseAB2012-01-19ALYACEN 1/35
60ANDA091636_001RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORETHINDRONE (0.5MG,0.75MG,1MG)TABLETFalseAB2012-01-19ALYACEN 7/7/7
61ANDA200488_001RXNORETHINDRONE (0.5MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2015-10-21NORETHINDRONE AND ETHINYL ESTRADIOL
62ANDA200489_001RXNORETHINDRONE (1MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2015-10-21NORETHINDRONE AND ETHINYL ESTRADIOL
63ANDA200897_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (0.4MG)TABLETTrueAB2015-05-11NORETHINDRONE AND ETHINYL ESTRADIOL
64ANDA201510_001RXNORETHINDRONE (0.5MG,0.75MG,1MG), ETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG)TABLETFalseAB2013-04-24PIRMELLA 7/7/7
65ANDA201512_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalseAB2013-04-24PIRMELLA 1/35
66ANDA201886_001RXNORETHINDRONE (0.4MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2013-09-26VYFEMLA
67ANDA202741_001RXETHINYL ESTRADIOL (0.03MG), NORETHINDRONE ACETATE (1.5MG)TABLETFalseAB2015-02-20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
68ANDA202742_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)ORALTABLETFalseAB2014-10-30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
69ANDA202770_001RXETHINYL ESTRADIOL (0.03MG), NORETHINDRONE ACETATE (1.5MG)TABLETFalseAB2015-02-19NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
70ANDA202771_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB2013-11-06NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
71ANDA202772_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB2013-11-14NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
72ANDA202994_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)ORALTABLETFalseAB2015-02-18LARIN 24 FE
73ANDA202995_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)TABLETFalseAB2013-12-04LARIN 1/20
74ANDA202996_001RXNORETHINDRONE ACETATE (1.5MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2014-03-20LARIN 1.5/30
75ANDA203006_001RXNORETHINDRONE (1MG), ETHINYL ESTRADIOL (0.05MG)TABLETTrue2013-08-05NORETHINDRONE AND ETHINYL ESTRADIOL
76ANDA203038_001RXETHINYL ESTRADIOL (0.0025MG), NORETHINDRONE ACETATE (0.5MG)ORALTABLETFalseAB2015-04-02NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
77ANDA203038_002RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.005MG)ORALTABLETFalseAB2015-04-02NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
78NDA016723_001discontinuedETHINYL ESTRADIOL (0.05MG), NORETHINDRONE ACETATE (1MG)TABLETFalseNORLESTRIN 28 1/50
79NDA016749_001discontinuedNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.05MG)TABLETFalseNORLESTRIN 21 1/50
80NDA016852_001discontinuedNORETHINDRONE ACETATE (2.5MG), ETHINYL ESTRADIOL (0.05MG)TABLETFalseNORLESTRIN 21 2.5/50
81NDA017354_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseABLOESTRIN FE 1/20
82NDA017355_001RXETHINYL ESTRADIOL (0.03MG), NORETHINDRONE ACETATE (1.5MG)TABLETTrueABLOESTRIN FE 1.5/30
83NDA017488_001discontinuedNORETHINDRONE (0.5MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseMODICON 21
84NDA017489_002discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalseORTHO-NOVUM 1/35-21
85NDA017565_001RXNORETHINDRONE (1MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseABNORINYL 1+35 21-DAY
86NDA017565_002RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETFalseABNORINYL 1+35 21-DAY
87NDA017566_001discontinuedNORETHINDRONE (0.5MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseBREVICON 21-DAY
88NDA017576_001discontinuedETHINYL ESTRADIOL (0.05MG), NORETHINDRONE (1MG)TABLETFalseOVCON-50
89NDA017716_001discontinuedNORETHINDRONE (0.4MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseOVCON-35
90NDA017735_001RXNORETHINDRONE (0.5MG), ETHINYL ESTRADIOL (0.035MG)TABLETTrueABMODICON 28
91NDA017743_001RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (0.5MG)TABLETFalseABBREVICON 28-DAY
92NDA017875_001RXETHINYL ESTRADIOL (0.03MG), NORETHINDRONE ACETATE (1.5MG)TABLETFalseABLOESTRIN 21 1.5/30
93NDA017876_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseABLOESTRIN 21 1/20
94NDA017919_002RXETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (1MG)TABLETTrueABORTHO-NOVUM 1/35-28
95NDA018127_001discontinuedETHINYL ESTRADIOL (0.035MG), NORETHINDRONE (0.4MG)TABLETFalseOVCON-35
96NDA018128_001discontinuedNORETHINDRONE (1MG), ETHINYL ESTRADIOL (0.05MG)TABLETFalseOVCON-50
97NDA018354_001discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG)TABLETFalse1982-01-11ORTHO-NOVUM 10/11-21
98NDA018354_002discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG)TABLETFalse1982-01-11ORTHO-NOVUM 10/11-21
99NDA018977_001discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG,0.5MG)TABLETFalse1984-04-13TRI-NORINYL 21-DAY
100NDA018977_002RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG,0.5MG)TABLETTrueAB1984-04-13TRI-NORINYL 21-DAY
101NDA018985_001discontinuedNORETHINDRONE (0.5MG,0.75MG,1MG), ETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG)TABLETFalse1984-04-04ORTHO-NOVUM 7/7/7-21
102NDA018985_002RXNORETHINDRONE (0.5MG,0.75MG,1MG), ETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG)TABLETTrueAB1984-04-04ORTHO-NOVUM 7/7/7-21
103NDA019004_001discontinuedNORETHINDRONE (0.5MG,1MG), ETHINYL ESTRADIOL (0.035MG,0.035MG)TABLETFalse1984-04-04ORTHO-NOVUM 7/14-21
104NDA019004_002discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG), NORETHINDRONE (0.5MG,1MG)TABLETFalse1984-04-04ORTHO-NOVUM 7/14-21
105NDA020130_001discontinuedNORETHINDRONE ACETATE (1MG,1MG,1MG), ETHINYL ESTRADIOL (0.02MG,0.03MG,0.035MG)TABLETFalse1996-10-09ESTROSTEP 21
106NDA020130_002RXNORETHINDRONE ACETATE (1MG,1MG,1MG), ETHINYL ESTRADIOL (0.02MG,0.03MG,0.035MG)TABLETTrueAB1996-10-09ESTROSTEP 21
107NDA021065_001RXETHINYL ESTRADIOL (0.0025MG), NORETHINDRONE ACETATE (0.5MG)ORALTABLETFalseAB2005-01-14FEMHRT
108NDA021065_002discontinuedNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.005MG)ORALTABLETFalse1999-10-15FEMHRT
109NDA021871_001discontinuedETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)ORALTABLETFalse2006-02-17LOESTRIN 24 FE
110NDA022501_001RXNORETHINDRONE ACETATE (1MG,N/A), ETHINYL ESTRADIOL (0.01MG,0.01MG)ORALTABLETTrue2010-10-21LO LOESTRIN FE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5552394 (view patent)2014-07-22NDA021871, NDA022501, NDA022573, NDA203667, NDA204426, NDA204654Ethinyl Estradiol Oral Tablet
Ethinyl Estradiol / Norethindrone Chewable Tablet
2p7704984 (view patent)2029-02-02NDA022501, NDA204654Ethinyl Estradiol Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10fece0aa-2b9c-40a3-975e-1ef2c2ef72f2 (view SPL)These highlights do not include all the information needed to use FEMHRT safely and effectively. See full prescribing information for FEMHRT . femhrt (norethindrone acetate/ethinyl estradiol tablets) Initial U.S. Approval: 1968prescriptionHuman PrescriptionWarner Chilcott (Us), Llc2014-02-018004300544, 004300145
22524b253-069e-4028-819c-361b888df110 (view SPL)ORTHO-NOVUM Tablets (norethindrone/ethinyl estradiol) and MODICON Tablets (norethindrone/ethinyl estradiol)prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-11-197504580171, 504580176, 504580178
3553fcd4d-f144-445f-8b41-0c33f4350a4a (view SPL)Microgestin 24 FeprescriptionHuman PrescriptionActavis Pharma, Inc.2015-11-232525440167
45ac5f3af-8cd8-4a96-88e6-3a8f820c17f2 (view SPL)Gildess 24 Fe (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets USP)prescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, MANUFACTURE, PACK2014-12-0210006037610
56b08d806-eb1f-4b25-9995-ae8321a6ff78 (view SPL)These highlights do not include all the information needed to use JEVANTIQUE LO safely and effectively. See full prescribing information for JEVANTIQUE LO . Jevantique Lo (norethindrone acetate/ethinyl estradiol tablet s) Initial U.S. Approval: 1968prescriptionHuman PrescriptionActavis Pharma, Inc.2015-11-201525440236
66fffc464-16c9-4a80-9b2b-1165395ca9d8 (view SPL)Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg **Ferrous fumarate tablets are not USP for dissolution and assay.prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.Analysis, Label, Manufacture, Pack2014-10-303003787301
7bb21b098-284a-4cad-bf8f-a062e88a3d56 (view SPL)Pirmella 1/35(norethindrone and ethinyl estradiol tablets USP)1 mg/0.035 mgRx OnlyprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2013-12-095681800893
8c6cfea6d-8a9d-4d4a-8e8c-d496c618efd0 (view SPL)GILDESS FE 1.5/30(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS FUMARATE TABLETS, USP)prescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, MANUFACTURE, PACK2014-01-0610006037608
9cf549b5a-2707-4020-9f94-dab1260e1664 (view SPL)These highlights do not include all the information needed to use norethindrone acetate and ethinyl estradiol safely and effectively. See full prescribing information fornorethindrone acetate and ethinyl estradiol. NORETHINDRONE acetate and ETHINYL ESTRADIOL tablets USP, for oral use Initial U.S. Approval: 1968prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-04-031684620656, 684620657
10cffba5ad-771c-4b14-9f8a-9155ca383ccb (view SPL)GILDESS FE 1/20(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS FUMARATE TABLETS, USP)prescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, PACK2014-01-0610006037609
11d5fcf844-2915-4c0c-b41a-9510dc0df5e5 (view SPL)GILDAGIATM(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 0.4 mg/0.035 mg) 28 DAY REGIMENprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2013-12-2717006033590
12d667ca75-1a17-43fc-9077-f25ce0908f8d (view SPL)These highlights do not include all the information needed to use Jinteli safely and effectively. See full prescribing information for Jinteli. Jinteli (norethindrone acetate and ethinyl estradiol tablets USP)Initial U.S. Approval: 1968prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-03-095000933122
13e6634d24-08af-44bc-8e76-e759619857fa (view SPL)JinteliTM (northindrone acetate and ethinyl estradiol tablets, USP)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-02-151548686251
14e94c80c9-fec0-42ba-8fce-dc993cb18e6a (view SPL)Vyfemla(norethindrone and ethinyl estradiol tablets USP)0.4 mg/0.035 mgprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2015-09-015681800875
15ffbf48de-0f61-49f9-9cd5-6eb8e08040db (view SPL)Junel Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets*)prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-291000935328

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII