Ethinyl Estradiol / Levonorgestrel Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lupin Pharmaceuticals, Inc. (2015-09-02)
Oldest Current Product
2012-10-24
License(s)
ANDA
RxNORM
ORAL TABLET\ETHINYL ESTRADIOL:LEVONORGESTREL
FDAOB
ORAL-21\TABLET\ETHINYL ESTRADIOL: LEVONORGESTREL\rdfq
ORAL-28\TABLET\ETHINYL ESTRADIOL: LEVONORGESTREL\rdfq
ORAL\TABLET\ETHINYL ESTRADIOL: LEVONORGESTREL
SPL Active
ORAL\TABLET, FILM COATED\ETHINYL ESTRADIOL: LEVONORGESTREL
ORAL\TABLET\ETHINYL ESTRADIOL: LEVONORGESTREL
SPL Moiety
ORAL\TABLET, FILM COATED\ETHINYL ESTRADIOL: LEVONORGESTREL
ORAL\TABLET\ETHINYL ESTRADIOL: LEVONORGESTREL

product(s) by strength(s)

ethinyl estradiol 0.02 mg / levonorgestrel 0.1 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787287ANDAMylan Pharmaceuticals Inc.2014-06-26ETHINYL ESTRADIOL, LEVONORGESTRELORALTABLETANDA200245c3c00dc0-8834-45fb-9f5b-810a98cef59d
2516600572ANDAOhm Laboratories Inc.2014-05-26ETHINYL ESTRADIOL, LEVONORGESTRELORALTABLET, FILM COATEDANDA20110847864f8c-0b43-47ff-a1df-d8ff57d3e4e5
3681800854ANDALupin Pharmaceuticals, Inc.2013-03-20ETHINYL ESTRADIOL, LEVONORGESTRELORALTABLETANDA091425b216c844-91db-49c5-843e-e384ccf4bf2f

ethinyl estradiol 0.03 mg / levonorgestrel 0.15 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787281ANDAMylan Pharmaceuticals Inc.2015-04-27ETHINYL ESTRADIOL, LEVONORGESTRELORALTABLETANDA200490af93fc89-c813-4a8c-9909-44729ab25a64
2681800843ANDALupin Pharmaceuticals, Inc.2012-10-24ETHINYL ESTRADIOL, LEVONORGESTRELORALTABLETANDA09144058e85e02-93e7-42ba-b8f5-a36290c68423
3684620672ANDAGlenmark Generics Inc., Usa2015-06-12ETHINYL ESTRADIOL, LEVONORGESTRELORALTABLET, FILM COATEDANDA2031643d87d9a4-860a-4ea7-a993-0f4adf1789da

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA073594LEVORA 0.15/30-28WATSON LABORATORIES INC1993-12-13ANDA073594_001Estrogens, Conjugated (USP) Oral Tablet
2ANDA074538TRIVORA-21WATSON LABORATORIES INC1997-12-18ANDA074538_001, ANDA074538_002Estrogens, Conjugated (USP) Oral Tablet
3ANDA075796AVIANE-21DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC2001-04-30ANDA075796_001, ANDA075796_002Estrogens, Conjugated (USP) Oral Tablet
4ANDA075803LESSINA-21BARR LABORATORIES INC2002-03-20ANDA075803_001, ANDA075803_002Estrogens, Conjugated (USP) Oral Tablet
5ANDA075809ENPRESSE-21DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC2001-07-16ANDA075809_001, ANDA075809_002Estrogens, Conjugated (USP) Oral Tablet
6ANDA075862LEVONORGESTREL AND ETHINYL ESTRADIOLTrueBARR LABORATORIES INC2003-04-29ANDA075862_001, ANDA075862_002Estrogens, Conjugated (USP) Oral Tablet
7ANDA075866PORTIA-21BARR LABORATORIES INC2002-05-23ANDA075866_001, ANDA075866_002Estrogens, Conjugated (USP) Oral Tablet
8ANDA076625LEVONORGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES2004-11-18ANDA076625_001Estrogens, Conjugated (USP) Oral Tablet
9ANDA077099ORSYTHIAVINTAGE PHARMACEUTICALS LLC2011-05-11ANDA077099_001Estrogens, Conjugated (USP) Oral Tablet
10ANDA077101QUASENSEWATSON LABORATORIES INC2006-09-06ANDA077101_001Ethinyl Estradiol Oral Tablet
11ANDA077502MYZILRAVINTAGE PHARMACEUTICALS LLC2011-11-23ANDA077502_001Estrogens, Conjugated (USP) Oral Tablet
12ANDA077681LEVONORGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2006-05-31ANDA077681_001Estrogens, Conjugated (USP) Oral Tablet
13ANDA078834LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2011-05-31ANDA078834_001Ethinyl Estradiol Oral Tablet
14ANDA079064INTROVALESANDOZ INC2010-09-27ANDA079064_001Ethinyl Estradiol Oral Tablet
15ANDA079102ALTAVERASANDOZ INC2010-08-03ANDA079102_001Estrogens, Conjugated (USP) Oral Tablet
16ANDA079218LEVONORGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2011-06-06ANDA079218_001Ethinyl Estradiol Oral Tablet
17ANDA090716SETLAKINNOVAST LABORATORIES LTD2014-09-15ANDA090716_001Ethinyl Estradiol Oral Tablet
18ANDA090719LEVONESTNOVAST LABORATORIES LTD2010-12-29ANDA090719_001Estrogens, Conjugated (USP) Oral Tablet
19ANDA090721FALMINANOVAST LABORATORIES LTD2012-03-28ANDA090721_001Estrogens, Conjugated (USP) Oral Tablet
20ANDA091408KURVELOLUPIN LTD2012-10-17ANDA091408_001Estrogens, Conjugated (USP) Oral Tablet
21ANDA091425LEVONORGESTREL AND ETHINYL ESTRADIOLLUPIN LTD2013-01-18ANDA091425_001Estrogens, Conjugated (USP) Oral Tablet
22ANDA091440LEVONORGESTREL AND ETHINYL ESTRADIOLLUPIN LTD2012-10-23ANDA091440_001Ethinyl Estradiol Oral Tablet
23ANDA091452MARLISSAGLENMARK GENERICS LTD2012-02-29ANDA091452_001Estrogens, Conjugated (USP) Oral Tablet
24ANDA091467DAYSEELUPIN LTD2013-04-10ANDA091467_001Ethinyl Estradiol Oral Tablet
25ANDA091663LEVONORGESTREL AND ETHINYL ESTRADIOLJAI PHARMA LTD2012-12-21ANDA091663_001Estrogens, Conjugated (USP) Oral Tablet
26ANDA091674LEVONORGESTREL AND ETHINYL ESTRADIOLLUPIN LIMITED2011-10-26ANDA091674_001Ethinyl Estradiol Oral Tablet
27ANDA200245LEVONORGESTREL AND ETHINYL ESTRADIOLJAI PHARMA LTD2013-10-09ANDA200245_001Estrogens, Conjugated (USP) Oral Tablet
28ANDA200407LEVONORGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2011-10-25ANDA200407_001Ethinyl Estradiol Oral Tablet
29ANDA200490LEVONORGESTREL AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-04-21ANDA200490_001Ethinyl Estradiol Oral Tablet
30ANDA200492LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-05-27ANDA200492_001Ethinyl Estradiol Oral Tablet
31ANDA200493LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-06-17ANDA200493_001Ethinyl Estradiol Oral Tablet
32ANDA201088VIENVASANDOZ INC2015-05-21ANDA201088_001Estrogens, Conjugated (USP) Oral Tablet
33ANDA201095LEVONORGESTREL AND ETHINYL ESTRADIOLHAUPT PHARMA INC2014-12-08ANDA201095_001Estrogens, Conjugated (USP) Oral Tablet
34ANDA201108LEVONORGESTREL AND ETHINYL ESTRADIOLHAUPT PHARMA INC2014-02-05ANDA201108_001Estrogens, Conjugated (USP) Oral Tablet
35ANDA202247LEVONORGESTREL AND ETHINYL ESTRADIOLJAI PHARMA LTD2014-12-08ANDA202247_001Estrogens, Conjugated (USP) Oral Tablet
36ANDA202791LEVONORGESTREL AND ETHINYL ESTRADIOLGLENMARK GENERICS LTD2015-04-09ANDA202791_001Ethinyl Estradiol Oral Tablet
37ANDA203163ASHLYNAGLENMARK GENERICS LTD2015-02-23ANDA203163_001Ethinyl Estradiol Oral Tablet
38ANDA203164LEVONORGESTREL AND ETHINYL ESTRADIOLGLENMARK PHARMACEUTICALS LTD2015-06-12ANDA203164_001Ethinyl Estradiol Oral Tablet
39NDA018782NORDETTE-28TrueTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC1982-07-21NDA018782_001Estrogens, Conjugated (USP) Oral Tablet
40NDA019190TRIPHASIL-28TrueWYETH PHARMACEUTICALS INC1984-11-01NDA019190_001Estrogens, Conjugated (USP) Oral Tablet
41NDA020683ALESSETrueWYETH PHARMACEUTICALS INC SUB PFIZER INC1997-03-27NDA020683_001, NDA020683_002Estrogens, Conjugated (USP) Oral Tablet
42NDA020860LEVLITETrueBAYER HEALTHCARE PHARMACEUTICALS INC1998-07-13NDA020860_001, NDA020860_002Estrogens, Conjugated (USP) Oral Tablet
43NDA020946PREVEN 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 Oral Tablet
44NDA021544SEASONALETEVA 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 Oral Tablet
45NDA021840SEASONIQUETEVA 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 Oral Tablet
46NDA021864LYBRELTrueWYETH PHARMACEUTICALS INC2007-05-22p6500814, PREVENTION OF PREGNANCYNDA021864_001Ethinyl Estradiol Oral Tablet
47NDA022262LOSEASONIQUETEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC2008-10-24p7615545, PREVENTION OF PREGNANCY
p7858605, SUBSTANCE
p7855190, PREVENTION OF PREGNANCY
NDA022262_001Ethinyl Estradiol Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073594_001RXLEVONORGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETTrueAB1993-12-13LEVORA 0.15/30-28
2ANDA074538_001discontinuedETHINYL ESTRADIOL (0.03MG,0.04MG,0.03MG), LEVONORGESTREL (0.05MG,0.075MG,0.125MG)TABLETFalse1997-12-18TRIVORA-21
3ANDA074538_002RXETHINYL ESTRADIOL (0.03MG,0.04MG,0.03MG), LEVONORGESTREL (0.05MG,0.075MG,0.125MG)TABLETTrueAB1997-12-18TRIVORA-21
4ANDA075796_001RXLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB12001-04-30AVIANE-21
5ANDA075796_002discontinuedLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalse2001-04-30AVIANE-21
6ANDA075803_001discontinuedLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalse2002-03-20LESSINA-21
7ANDA075803_002RXETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.1MG)TABLETFalseAB22002-03-20LESSINA-21
8ANDA075809_001discontinuedLEVONORGESTREL (0.05MG,0.075MG,0.125MG), ETHINYL ESTRADIOL (0.03MG,0.04MG,0.03MG)TABLETFalse2001-07-16ENPRESSE-21
9ANDA075809_002RXETHINYL ESTRADIOL (0.03MG,0.04MG,0.03MG), LEVONORGESTREL (0.05MG,0.075MG,0.125MG)TABLETFalseAB2001-07-16ENPRESSE-21
10ANDA075862_001discontinuedLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalse2003-04-29LEVONORGESTREL AND ETHINYL ESTRADIOL
11ANDA075862_002discontinuedETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.1MG)TABLETFalse2003-04-29LEVONORGESTREL AND ETHINYL ESTRADIOL
12ANDA075866_001discontinuedETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)TABLETFalse2002-05-23PORTIA-21
13ANDA075866_002RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)TABLETFalseAB2002-05-23PORTIA-21
14ANDA076625_001RXETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.1MG)TABLETTrueAB12004-11-18LEVONORGESTREL AND ETHINYL ESTRADIOL
15ANDA077099_001RXLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB12011-05-11ORSYTHIA
16ANDA077101_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETFalseAB2006-09-06QUASENSE
17ANDA077502_001RXLEVONORGESTREL (0.05MG,0.075MG,0.125MG), ETHINYL ESTRADIOL (0.03MG,0.04MG,0.03MG)TABLETFalseAB2011-11-23MYZILRA
18ANDA077681_001RXLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETTrueAB22006-05-31LEVONORGESTREL AND ETHINYL ESTRADIOL
19ANDA078834_001RXLEVONORGESTREL (0.15MG,N/A), ETHINYL ESTRADIOL (0.03MG,0.01MG)ORALTABLETFalseAB2011-05-31LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
20ANDA079064_001RXLEVONORGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)ORALTABLETFalseAB2010-09-27INTROVALE
21ANDA079102_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)TABLETFalseAB2010-08-03ALTAVERA
22ANDA079218_001RXETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.09MG)ORALTABLETTrueAB2011-06-06LEVONORGESTREL AND ETHINYL ESTRADIOL
23ANDA090716_001RXLEVONORGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)ORALTABLETFalseAB2014-09-15SETLAKIN
24ANDA090719_001RXETHINYL ESTRADIOL (0.03MG,0.04MG,0.03MG), LEVONORGESTREL (0.05MG,0.075MG,0.125MG)TABLETFalseAB2010-12-29LEVONEST
25ANDA090721_001RXLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB12012-03-28FALMINA
26ANDA091408_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)TABLETFalseAB2012-10-17KURVELO
27ANDA091425_001RXLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB12013-01-18LEVONORGESTREL AND ETHINYL ESTRADIOL
28ANDA091440_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETFalseAB2012-10-23LEVONORGESTREL AND ETHINYL ESTRADIOL
29ANDA091452_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)TABLETFalseAB2012-02-29MARLISSA
30ANDA091467_001RXETHINYL ESTRADIOL (0.03MG,0.01MG), LEVONORGESTREL (0.15MG,N/A)ORALTABLETFalseAB2013-04-10DAYSEE
31ANDA091663_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)TABLETFalseAB2012-12-21LEVONORGESTREL AND ETHINYL ESTRADIOL
32ANDA091674_001RXLEVONORGESTREL (0.1MG,N/A), ETHINYL ESTRADIOL (0.02MG,0.01MG)ORALTABLETFalseAB2011-10-26LEVONORGESTREL AND ETHINYL ESTRADIOL
33ANDA200245_001RXETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.1MG)TABLETFalseAB12013-10-09LEVONORGESTREL AND ETHINYL ESTRADIOL
34ANDA200407_001RXETHINYL ESTRADIOL (0.02MG,0.01MG), LEVONORGESTREL (0.1MG,N/A)ORALTABLETFalseAB2011-10-25LEVONORGESTREL AND ETHINYL ESTRADIOL
35ANDA200490_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETFalseAB2015-04-21LEVONORGESTREL AND ETHINYL ESTRADIOL
36ANDA200492_001RXETHINYL ESTRADIOL (0.03MG,0.01MG), LEVONORGESTREL (0.15MG,N/A)ORALTABLETFalseAB2015-05-27LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
37ANDA200493_001RXLEVONORGESTREL (0.1MG,N/A), ETHINYL ESTRADIOL (0.02MG,0.01MG)ORALTABLETFalseAB2015-06-17LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
38ANDA201088_001RXLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB12015-05-21VIENVA
39ANDA201095_001RXLEVONORGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2014-12-08LEVONORGESTREL AND ETHINYL ESTRADIOL
40ANDA201108_001RXLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalseAB12014-02-05LEVONORGESTREL AND ETHINYL ESTRADIOL
41ANDA202247_001RXETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.1MG)TABLETFalseAB22014-12-08LEVONORGESTREL AND ETHINYL ESTRADIOL
42ANDA202791_001RXLEVONORGESTREL (0.09MG), ETHINYL ESTRADIOL (0.02MG)ORALTABLETFalseAB2015-04-09LEVONORGESTREL AND ETHINYL ESTRADIOL
43ANDA203163_001RXETHINYL ESTRADIOL (0.03MG,0.01MG), LEVONORGESTREL (0.15MG,N/A)ORALTABLETFalseAB2015-02-23ASHLYNA
44ANDA203164_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETFalseAB2015-06-12LEVONORGESTREL AND ETHINYL ESTRADIOL
45NDA018782_001discontinuedLEVONORGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalse1982-07-21NORDETTE-28
46NDA019190_001discontinuedLEVONORGESTREL (0.05MG,0.075MG,0.125MG), ETHINYL ESTRADIOL (0.03MG,0.04MG,0.03MG)TABLETFalse1984-11-01TRIPHASIL-28
47NDA020683_001discontinuedLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalse1997-03-27ALESSE
48NDA020683_002discontinuedLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalse1997-03-27ALESSE
49NDA020860_001discontinuedETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.1MG)TABLETFalse1998-07-13LEVLITE
50NDA020860_002discontinuedLEVONORGESTREL (0.1MG), ETHINYL ESTRADIOL (0.02MG)TABLETFalse1998-07-13LEVLITE
51NDA020946_001discontinuedLEVONORGESTREL (0.25MG), ETHINYL ESTRADIOL (0.05MG)ORALTABLETFalse1998-09-01PREVEN EMERGENCY CONTRACEPTIVE KIT
52NDA021544_001RXETHINYL ESTRADIOL (0.03MG), LEVONORGESTREL (0.15MG)ORALTABLETTrueAB2003-09-05SEASONALE
53NDA021840_001RXLEVONORGESTREL (0.15MG,N/A), ETHINYL ESTRADIOL (0.03MG,0.01MG)ORALTABLETTrueAB2006-05-25SEASONIQUE
54NDA021864_001discontinuedETHINYL ESTRADIOL (0.02MG), LEVONORGESTREL (0.09MG)ORALTABLETFalse2007-05-22LYBREL
55NDA022262_001RXETHINYL ESTRADIOL (0.02MG,0.01MG), LEVONORGESTREL (0.1MG,N/A)ORALTABLETFalseAB2008-10-24LOSEASONIQUE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5898032 (view patent)2017-06-23NDA021544Ethinyl Estradiol Oral Tablet
2p6156742 (view patent)2020-12-05NDA020946Ethinyl Estradiol Oral Tablet
3p6500814 (view patent)2018-09-03NDA021864Ethinyl Estradiol Oral Tablet
4p7320969 (view patent)2024-01-30NDA021840Ethinyl Estradiol Oral Tablet
5p7615545 (view patent)2023-06-15NDA021840, NDA022262Ethinyl Estradiol Oral Tablet
6p7855190 (view patent)2028-12-05NDA021840, NDA022262Ethinyl Estradiol Oral Tablet
7p7858605 (view patent)2023-06-23NDA021840, NDA022262Ethinyl Estradiol Oral Tablet
8pRE39861 (view patent)2017-06-23NDA021544Ethinyl Estradiol Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13d87d9a4-860a-4ea7-a993-0f4adf1789da (view SPL)Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-06-121684620672
247864f8c-0b43-47ff-a1df-d8ff57d3e4e5 (view SPL)DELYLA(Levonorgestrel and Ethinyl Estradiol Tablets, USP)Rx onlyprescriptionHuman PrescriptionOhm Laboratories Inc.api manufacture, manufacture2014-03-251516600572
358e85e02-93e7-42ba-b8f5-a36290c68423 (view SPL)Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg /0.03 mgprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2015-09-026681800843
4af93fc89-c813-4a8c-9909-44729ab25a64 (view SPL)Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg / 0.03 mgprescriptionHuman PrescriptionMylan Pharmaceuticals Inc.analysis, label, manufacture, pack2015-04-304003787281
5b216c844-91db-49c5-843e-e384ccf4bf2f (view SPL)Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mgprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture, pack2015-08-016681800854
6c3c00dc0-8834-45fb-9f5b-810a98cef59d (view SPL)Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mgprescriptionHuman PrescriptionMylan Pharmaceuticals Inc.Analysis, Label, Manufacture, Pack2014-06-262003787287

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