Ethinyl Estradiol / norgestimate Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2015-06-16)
Oldest Current Product
2003-01-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ETHINYL ESTRADIOL:NORGESTIMATE
FDAOB
ORAL-21\TABLET\ETHINYL ESTRADIOL: NORGESTIMATE\rdfq
ORAL-28\TABLET\ETHINYL ESTRADIOL: NORGESTIMATE\rdfq
SPL Active
ORAL\TABLET, COATED\ETHINYL ESTRADIOL: NORGESTIMATE
ORAL\TABLET\ETHINYL ESTRADIOL: NORGESTIMATE
SPL Moiety
ORAL\TABLET, COATED\ETHINYL ESTRADIOL: NORGESTIMATE
ORAL\TABLET\ETHINYL ESTRADIOL: NORGESTIMATE

product(s) by strength(s)

ethinyl estradiol 0.035 mg / norgestimate 0.25 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440247NDAActavis Pharma, Inc.2003-01-01ETHINYL ESTRADIOL, NORGESTIMATEORALTABLET, COATEDNDA019653704ba4ae-edd0-4298-a399-03a49f8411c7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1684620309ANDAGlenmark Generics Inc., Usa2012-04-06ETHINYL ESTRADIOL, NORGESTIMATEORALTABLETANDA2005388b247e46-203e-4f5b-b5a7-cbd57341c735, beabee48-1912-47bf-a9b5-d5c426c4fcc2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1631870054NDAProficient Rx Lp2003-01-01ETHINYL ESTRADIOL, NORGESTIMATEORALTABLET, COATED525440247NDA0196537e6ff7b1-bd5c-475c-a6af-eac7f10fd2ea

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA075804SPRINTECBARR LABORATORIES INC2002-09-25ANDA075804_001
2ANDA075808TRI-SPRINTECBARR LABORATORIES INC2003-12-29ANDA075808_001
3ANDA076334PREVIFEMVINTAGE PHARMACEUTICALS LLC2004-01-09ANDA076334_001
4ANDA076335TRI-PREVIFEMVINTAGE PHARMACEUTICALS LLC2004-03-26ANDA076335_001
5ANDA076626NORGESTIMATE AND ETHINYL ESTRADIOLTrueWATSON LABORATORIES INC2006-08-17ANDA076626_001
6ANDA076627NORGESTIMATE AND ETHINYL ESTRADIOLTrueWATSON LABORATORIES INC2006-08-17ANDA076627_001
7ANDA076784TRI LO SPRINTECTrueBARR LABORATORIES INC2009-06-29ANDA076784_001
8ANDA090479NORGESTIMATE AND ETHINYL ESTRADIOLTrueWATSON LABORATORIES INC2011-03-09ANDA090479_001
9ANDA090523MONO-LINYAHNOVAST LABORATORIES LTD2012-05-23ANDA090523_001
10ANDA090524TRI-LINYAHNOVAST LABORATORIES LTD2012-05-30ANDA090524_001
11ANDA090793TRI-ESTARYLLASANDOZ INC2013-01-30ANDA090793_001
12ANDA090794ESTARYLLASANDOZ INC2013-01-30ANDA090794_001
13ANDA091232TRI-LO-ESTARYLLASANDOZ INC2015-06-29ANDA091232_001
14ANDA200384NORGESTIMATE AND ETHINYL ESTRADIOLOC PHARMA LLC2015-04-07ANDA200384_001
15ANDA200538NORGESTIMATE AND ETHINYL ESTRADIOLGLENMARK GENERICS LTD2012-04-05ANDA200538_001
16ANDA200541NORGESTIMATE AND ETHINYL ESTRADIOLLUPIN PHARMACEUTICALS INC2012-06-25ANDA200541_001
17ANDA202132NORGESTIMATE AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-09-09ANDA202132_001
18ANDA203865NORGESTIMATE AND ETHINYL ESTRADIOLHAUPT PHARMA INC2015-10-27ANDA203865_001
19ANDA203870NORGESTIMATE AND ETHINYL ESTRADIOLHAUPT PHARMA INC2015-11-12ANDA203870_001
20NDA019653ORTHO CYCLEN-21JANSSEN PHARMACEUTICALS INC1989-12-29NDA019653_001, NDA019653_002
21NDA019697ORTHO TRI-CYCLENJANSSEN PHARMACEUTICALS INC1992-07-03NDA019697_001, NDA019697_002
22NDA021241ORTHO TRI-CYCLEN LOJANSSEN PHARMACEUTICALS INC2002-08-22p6214815, CONTRACEPTIONNDA021241_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075804_001RXETHINYL ESTRADIOL (0.035MG), NORGESTIMATE (0.25MG)TABLETFalseAB2002-09-25SPRINTEC
2ANDA075808_001RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalseAB2003-12-29TRI-SPRINTEC
3ANDA076334_001RXNORGESTIMATE (0.25MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2004-01-09PREVIFEM
4ANDA076335_001RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalseAB2004-03-26TRI-PREVIFEM
5ANDA076626_001discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalse2006-08-17NORGESTIMATE AND ETHINYL ESTRADIOL
6ANDA076627_001discontinuedETHINYL ESTRADIOL (0.035MG), NORGESTIMATE (0.25MG)TABLETFalse2006-08-17NORGESTIMATE AND ETHINYL ESTRADIOL
7ANDA076784_001discontinuedNORGESTIMATE (0.18MG,0.215MG,0.25MG), ETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG)TABLETFalse2009-06-29TRI LO SPRINTEC
8ANDA090479_001discontinuedETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalse2011-03-09NORGESTIMATE AND ETHINYL ESTRADIOL
9ANDA090523_001RXNORGESTIMATE (0.25MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2012-05-23MONO-LINYAH
10ANDA090524_001RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalseAB2012-05-30TRI-LINYAH
11ANDA090793_001RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalseAB2013-01-30TRI-ESTARYLLA
12ANDA090794_001RXNORGESTIMATE (0.25MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2013-01-30ESTARYLLA
13ANDA091232_001RXETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalseAB2015-06-29TRI-LO-ESTARYLLA
14ANDA200384_001RXETHINYL ESTRADIOL (0.035MG), NORGESTIMATE (0.25MG)TABLETFalseAB2015-04-07NORGESTIMATE AND ETHINYL ESTRADIOL
15ANDA200538_001RXETHINYL ESTRADIOL (0.035MG), NORGESTIMATE (0.25MG)TABLETFalseAB2012-04-05NORGESTIMATE AND ETHINYL ESTRADIOL
16ANDA200541_001RXETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalseAB2012-06-25NORGESTIMATE AND ETHINYL ESTRADIOL
17ANDA202132_001RXETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalseAB2015-09-09NORGESTIMATE AND ETHINYL ESTRADIOL
18ANDA203865_001RXNORGESTIMATE (0.25MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalseAB2015-10-27NORGESTIMATE AND ETHINYL ESTRADIOL
19ANDA203870_001RXETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalseAB2015-11-12NORGESTIMATE AND ETHINYL ESTRADIOL
20NDA019653_001discontinuedNORGESTIMATE (0.25MG), ETHINYL ESTRADIOL (0.035MG)TABLETFalse1989-12-29ORTHO CYCLEN-21
21NDA019653_002RXETHINYL ESTRADIOL (0.035MG), NORGESTIMATE (0.25MG)TABLETTrueAB1989-12-29ORTHO CYCLEN-21
22NDA019697_001RXNORGESTIMATE (0.18MG,0.215MG,0.25MG), ETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG)TABLETTrueAB1992-07-03ORTHO TRI-CYCLEN
23NDA019697_002discontinuedETHINYL ESTRADIOL (0.035MG,0.035MG,0.035MG), NORGESTIMATE (0.18MG,0.215MG,0.25MG)TABLETFalse1992-07-03ORTHO TRI-CYCLEN
24NDA021241_001RXNORGESTIMATE (0.18MG,0.215MG,0.25MG), ETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG)TABLETTrueAB2002-08-22ORTHO TRI-CYCLEN LO

patent(s)

#idexpiration dateapplication(s)
1p6214815 (view patent)2019-06-09NDA021241

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1704ba4ae-edd0-4298-a399-03a49f8411c7 (view SPL)These highlights do not include all the information needed to use MonoNessa or TriNessa safely and effectively. See full prescribing information for MonoNessa and TriNessa. MonoNessa and TriNessa (norgestimate/ethinyl estradiol) tablets, for oral useInitial U.S. Approval: 1989prescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-165525440247, 525440248
27e6ff7b1-bd5c-475c-a6af-eac7f10fd2ea (view SPL)MonoNessa Tablets (norgestimate and ethinyl estradiol)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-06-061631870054
38b247e46-203e-4f5b-b5a7-cbd57341c735 (view SPL)These highlights do not include all the information needed to use norgestimate and ethinyl estradiol tablets safely and effectively. See full prescribing information for norgestimate and ethinyl estradiol tablets. NORGESTIMATE and ETHINYL ESTRADIOL tablets USP, 0.25 mg/0.035 mg, for oral useNORGESTIMATE and ETHINYL ESTRADIOL tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-06-268684620309, 684620565
4beabee48-1912-47bf-a9b5-d5c426c4fcc2 (view SPL)Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2012-04-135684620309

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