Ethinyl Estradiol Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Warner Chilcott (Us), Llc (2012-06-28)
Oldest Current Product
2010-12-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ETHINYL ESTRADIOL
FDAOB
ORAL\TABLET\ETHINYL ESTRADIOL: LEVONORGESTREL
ORAL\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE ACETATE
SPL Active
ORAL\TABLET\ETHINYL ESTRADIOL: LEVONORGESTREL
ORAL\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE ACETATE
SPL Moiety
ORAL\TABLET\ETHINYL ESTRADIOL: LEVONORGESTREL
ORAL\TABLET\ETHINYL ESTRADIOL: NORETHINDRONE

product(s) by strength(s)

ethinyl estradiol 0.01 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004300420NDAWarner Chilcott (Us), Llc2010-12-01ETHINYL ESTRADIOL, NORETHINDRONE ACETATEORALTABLETNDA022501c33072cf-625d-4b4a-981e-ec049c5d78aa

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787285ANDAMylan Pharmaceuticals Inc.2015-05-28ETHINYL ESTRADIOL, LEVONORGESTRELORALTABLETANDA200492e5eb2533-cc31-43a8-8fca-d46d72a59530

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA076221NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLBARR LABORATORIES INC2009-11-06ANDA076221_001Ethinyl Estradiol / Norethindrone Oral Tablet
2ANDA077101QUASENSEWATSON LABORATORIES INC2006-09-06ANDA077101_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
3ANDA078267NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAMNEAL PHARMACEUTICALS OF NEW YORK LLC2009-09-01ANDA078267_001Ethinyl Estradiol / Norethindrone Oral Tablet
4ANDA078834LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2011-05-31ANDA078834_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
5ANDA079064INTROVALESANDOZ INC2010-09-27ANDA079064_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
6ANDA079218LEVONORGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2011-06-06ANDA079218_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
7ANDA090293GILDESS 24 FEVINTAGE PHARMACEUTICALS2014-12-01ANDA090293_001Ethinyl Estradiol / Norethindrone Oral Tablet
8ANDA090716SETLAKINNOVAST LABORATORIES LTD2014-09-15ANDA090716_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
9ANDA090938NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEBARR LABORATORIES INC2014-12-01ANDA090938_001Ethinyl Estradiol / Norethindrone Oral Tablet
10ANDA091398BLISOVI 24 FELUPIN LTD2015-10-28ANDA091398_001Ethinyl Estradiol / Norethindrone Oral Tablet
11ANDA091440LEVONORGESTREL AND ETHINYL ESTRADIOLLUPIN LTD2012-10-23ANDA091440_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
12ANDA091467DAYSEELUPIN LTD2013-04-10ANDA091467_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
13ANDA091674LEVONORGESTREL AND ETHINYL ESTRADIOLLUPIN LIMITED2011-10-26ANDA091674_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
14ANDA200407LEVONORGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2011-10-25ANDA200407_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
15ANDA200490LEVONORGESTREL AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-04-21ANDA200490_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
16ANDA200492LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-05-27ANDA200492_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
17ANDA200493LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-06-17ANDA200493_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
18ANDA202742NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEJAI PHARMA LTD2014-10-30ANDA202742_001Ethinyl Estradiol / Norethindrone Oral Tablet
19ANDA202791LEVONORGESTREL AND ETHINYL ESTRADIOLGLENMARK GENERICS LTD2015-04-09ANDA202791_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
20ANDA202994LARIN 24 FENOVAST LABORATORIES LTD2015-02-18ANDA202994_001Ethinyl Estradiol / Norethindrone Oral Tablet
21ANDA203038NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGLENMARK GENERICS LTD2015-04-02ANDA203038_001, ANDA203038_002Ethinyl Estradiol / Norethindrone Oral Tablet
22ANDA203163ASHLYNAGLENMARK GENERICS LTD2015-02-23ANDA203163_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
23ANDA203164LEVONORGESTREL AND ETHINYL ESTRADIOLGLENMARK PHARMACEUTICALS LTD2015-06-12ANDA203164_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
24NDA020946PREVEN EMERGENCY CONTRACEPTIVE KITTrueTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC1998-09-01p6156742, KIT ADAPTED AND DESIGNED TO PROVIDE BOTH DATA ON THE CURRENT REPRODUCTIVE STATUS OF A PATIENT AND CONTRACEPTION FOR THOSE WHO ARE NOT PREGNANTNDA020946_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
25NDA021065FEMHRTWARNER CHILCOTT CO LLC1999-10-15NDA021065_001, NDA021065_002Ethinyl Estradiol / Norethindrone Oral Tablet
26NDA021544SEASONALETEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC2003-09-05pRE39861, PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION
p5898032, PREVENTION OF PREGNANCY
NDA021544_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
27NDA021840SEASONIQUETEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC2006-05-25p7615545, PREVENTION OF PREGNANCY
p7858605, SUBSTANCE
p7320969, PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION
p7855190, PREVENTION OF PREGNANCY
NDA021840_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
28NDA021864LYBRELTrueWYETH PHARMACEUTICALS INC2007-05-22p6500814, PREVENTION OF PREGNANCYNDA021864_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
29NDA021871LOESTRIN 24 FETrueWARNER CHILCOTT INC2006-02-17p5552394, PREVENTION OF PREGNANCYNDA021871_001Ethinyl Estradiol / Norethindrone Oral Tablet
30NDA022262LOSEASONIQUETEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC2008-10-24p7615545, PREVENTION OF PREGNANCY
p7858605, SUBSTANCE
p7855190, PREVENTION OF PREGNANCY
NDA022262_001Ethinyl Estradiol / Levonorgestrel Oral Tablet
31NDA022501LO 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 / Norethindrone Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076221_001RXETHINYL ESTRADIOL (0.005MG), NORETHINDRONE ACETATE (1MG)ORALTABLETTrueAB2009-11-06NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
2ANDA077101_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETFalseAB2006-09-06QUASENSE
3ANDA078267_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)ORALTABLETTrueAB2009-09-01NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
4ANDA078834_001RXLEVONORGESTREL (0.15MG,N/A), ETHINYL ESTRADIOL (0.03MG,0.01MG)ORALTABLETFalseAB2011-05-31LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
5ANDA079064_001RXLEVONORGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)ORALTABLETFalseAB2010-09-27INTROVALE
6ANDA079218_001RXETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.09MG)ORALTABLETTrueAB2011-06-06LEVONORGESTREL AND ETHINYL ESTRADIOL
7ANDA090293_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)ORALTABLETFalseAB2014-12-01GILDESS 24 FE
8ANDA090716_001RXLEVONORGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)ORALTABLETFalseAB2014-09-15SETLAKIN
9ANDA090938_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)ORALTABLETFalseAB2014-12-01NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
10ANDA091398_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)ORALTABLETFalseAB2015-10-28BLISOVI 24 FE
11ANDA091440_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETFalseAB2012-10-23LEVONORGESTREL AND ETHINYL ESTRADIOL
12ANDA091467_001RXETHINYL ESTRADIOL (0.03MG,0.01MG), LEVONORGESTREL (0.15MG,N/A)ORALTABLETFalseAB2013-04-10DAYSEE
13ANDA091674_001RXLEVONORGESTREL (0.1MG,N/A), ETHINYL ESTRADIOL (0.02MG,0.01MG)ORALTABLETFalseAB2011-10-26LEVONORGESTREL AND ETHINYL ESTRADIOL
14ANDA200407_001RXETHINYL ESTRADIOL (0.02MG,0.01MG), LEVONORGESTREL (0.1MG,N/A)ORALTABLETFalseAB2011-10-25LEVONORGESTREL AND ETHINYL ESTRADIOL
15ANDA200490_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETFalseAB2015-04-21LEVONORGESTREL AND ETHINYL ESTRADIOL
16ANDA200492_001RXETHINYL ESTRADIOL (0.03MG,0.01MG), LEVONORGESTREL (0.15MG,N/A)ORALTABLETFalseAB2015-05-27LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
17ANDA200493_001RXLEVONORGESTREL (0.1MG,N/A), ETHINYL ESTRADIOL (0.02MG,0.01MG)ORALTABLETFalseAB2015-06-17LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
18ANDA202742_001RXETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)ORALTABLETFalseAB2014-10-30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
19ANDA202791_001RXLEVONORGESTREL (0.09MG), ETHINYL ESTRADIOL (0.02MG)ORALTABLETFalseAB2015-04-09LEVONORGESTREL AND ETHINYL ESTRADIOL
20ANDA202994_001RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.02MG)ORALTABLETFalseAB2015-02-18LARIN 24 FE
21ANDA203038_001RXETHINYL ESTRADIOL (0.0025MG), NORETHINDRONE ACETATE (0.5MG)ORALTABLETFalseAB2015-04-02NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
22ANDA203038_002RXNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.005MG)ORALTABLETFalseAB2015-04-02NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
23ANDA203163_001RXETHINYL ESTRADIOL (0.03MG,0.01MG), LEVONORGESTREL (0.15MG,N/A)ORALTABLETFalseAB2015-02-23ASHLYNA
24ANDA203164_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETFalseAB2015-06-12LEVONORGESTREL AND ETHINYL ESTRADIOL
25NDA020946_001discontinuedLEVONORGESTREL (0.25MG), ETHINYL ESTRADIOL (0.05MG)ORALTABLETFalse1998-09-01PREVEN EMERGENCY CONTRACEPTIVE KIT
26NDA021065_001RXETHINYL ESTRADIOL (0.0025MG), NORETHINDRONE ACETATE (0.5MG)ORALTABLETFalseAB2005-01-14FEMHRT
27NDA021065_002discontinuedNORETHINDRONE ACETATE (1MG), ETHINYL ESTRADIOL (0.005MG)ORALTABLETFalse1999-10-15FEMHRT
28NDA021544_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETTrueAB2003-09-05SEASONALE
29NDA021840_001RXLEVONORGESTREL (0.15MG,N/A), ETHINYL ESTRADIOL (0.03MG,0.01MG)ORALTABLETTrueAB2006-05-25SEASONIQUE
30NDA021864_001discontinuedETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.09MG)ORALTABLETFalse2007-05-22LYBREL
31NDA021871_001discontinuedETHINYL ESTRADIOL (0.02MG), NORETHINDRONE ACETATE (1MG)ORALTABLETFalse2006-02-17LOESTRIN 24 FE
32NDA022262_001RXETHINYL ESTRADIOL (0.02MG,0.01MG), LEVONORGESTREL (0.1MG,N/A)ORALTABLETFalseAB2008-10-24LOSEASONIQUE
33NDA022501_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 / Norethindrone Chewable Tablet
Ethinyl Estradiol / Norethindrone Oral Tablet
2p5898032 (view patent)2017-06-23NDA021544Ethinyl Estradiol / Levonorgestrel Oral Tablet
3p6156742 (view patent)2020-12-05NDA020946Ethinyl Estradiol / Levonorgestrel Oral Tablet
4p6500814 (view patent)2018-09-03NDA021864Ethinyl Estradiol / Levonorgestrel Oral Tablet
5p7320969 (view patent)2024-01-30NDA021840Ethinyl Estradiol / Levonorgestrel Oral Tablet
6p7615545 (view patent)2023-06-15NDA021840, NDA022262Ethinyl Estradiol / Levonorgestrel Oral Tablet
7p7704984 (view patent)2029-02-02NDA022501, NDA204654Ethinyl Estradiol / Norethindrone Oral Tablet
8p7855190 (view patent)2028-12-05NDA021840, NDA022262Ethinyl Estradiol / Levonorgestrel Oral Tablet
9p7858605 (view patent)2023-06-23NDA021840, NDA022262Ethinyl Estradiol / Levonorgestrel Oral Tablet
10pRE39861 (view patent)2017-06-23NDA021544Ethinyl Estradiol / Levonorgestrel Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1c33072cf-625d-4b4a-981e-ec049c5d78aa (view SPL)These highlights do not include all the information needed to use Lo Loestrin Fe safely and effectively. See Full Prescribing Information for Lo Loestrin Fe. Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) Initial U.S. Approval: 1968prescriptionHuman PrescriptionWarner Chilcott (Us), LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2012-06-283004300420
2e5eb2533-cc31-43a8-8fca-d46d72a59530 (view SPL)These highlights do not include all the information needed to use levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets safely and effectively. See full prescribing information for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets.Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for oral use Initial U.S. Approval: 1982prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-06-295003787285

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