Desogestrel / Ethinyl Estradiol Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Organon Usa Inc. (2014-06-16)
Oldest Current Product
2010-06-10
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\DESOGESTREL:ETHINYL ESTRADIOL
FDAOB
ORAL-21\TABLET\DESOGESTREL: ETHINYL ESTRADIOL\rdfq
ORAL-28\TABLET\DESOGESTREL: ETHINYL ESTRADIOL\rdfq
SPL Active
ORAL\TABLET, FILM COATED\DESOGESTREL: ETHINYL ESTRADIOL
ORAL\TABLET\DESOGESTREL: ETHINYL ESTRADIOL
SPL Moiety
ORAL\TABLET, FILM COATED\DESOGESTREL: ETHINYL ESTRADIOL
ORAL\TABLET\DESOGESTREL: ETHINYL ESTRADIOL

product(s) by strength(s)

desogestrel 0.15 mg / ethinyl estradiol 0.02 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1167140367ANDANorthstar Rx Llc2014-05-30DESOGESTREL, ETHINYL ESTRADIOLORALTABLETANDA091234ac92c9d8-8fbb-494d-81fc-21c55148dbc4

desogestrel 0.15 mg / ethinyl estradiol 0.03 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000520261NDAOrganon Usa Inc.2010-06-10DESOGESTREL, ETHINYL ESTRADIOLORALTABLETNDA020071145f757f-c900-4aee-a862-b0ad60e64ed6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1501020154ANDAAfaxys Inc.2015-08-07DESOGESTREL, ETHINYL ESTRADIOLORALTABLETANDA2020853b46d7d9-6ed5-4bf0-86d1-9798df6a20a2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1617860382ANDARemedyrepack Inc.2015-07-28DESOGESTREL, ETHINYL ESTRADIOLORALTABLET, FILM COATED006037540ANDA076675fa4fcf86-c79b-4745-ade7-0df01e04eba0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075256DESOGESTREL AND ETHINYL ESTRADIOLDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1999-08-12ANDA075256_001, ANDA075256_002
2ANDA075863KARIVABARR LABORATORIES INC2002-04-05ANDA075863_001
3ANDA076455VELIVETDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC2004-02-24ANDA076455_001
4ANDA076675EMOQUETTEVINTAGE PHARMACEUTICALS LLC2011-02-25ANDA076675_001
5ANDA076681KIMIDESSVINTAGE PHARMACEUTICALS2015-04-30ANDA076681_001
6ANDA076915DESOGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2005-07-29ANDA076915_001
7ANDA076916DESOGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2008-12-29ANDA076916_001
8ANDA077182DESOGESTREL AND ETHINYL ESTRADIOLWATSON LABORATORIES INC2006-01-24ANDA077182_001
9ANDA091234DESOGESTREL AND ETHINYL ESTRADIOLNOVAST LABORATORIES LTD2013-07-12ANDA091234_001
10ANDA091247PIMTREANOVAST LABORATORIES LTD2013-08-01ANDA091247_001
11ANDA091346VIORELEGLENMARK GENERICS LTD2012-04-02ANDA091346_001
12ANDA201887ENSKYCELUPIN LTD2013-03-07ANDA201887_001
13ANDA202085DESOGESTREL AND ETHINYL ESTRADIOLJAI PHARMA LTD2015-05-20ANDA202085_001
14ANDA202226BEKYREELUPIN LTD2015-08-12ANDA202226_001
15ANDA202296DESOGESTREL AND ETHINYL ESTRADIOLJAI PHARMA LTD2013-08-30ANDA202296_001
16ANDA202789ISIBLOOMSANDOZ INC2015-08-12ANDA202789_001
17NDA020071DESOGENORGANON USA INC1992-12-10NDA020071_001, NDA020071_002
18NDA020301ORTHO-CEPTJANSSEN PHARMACEUTICALS INC1992-12-14NDA020301_001, NDA020301_002
19NDA020713MIRCETTETrueTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC1998-04-22NDA020713_001
20NDA021090CYCLESSAASPEN GLOBAL INC2000-12-20NDA021090_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075256_001discontinuedDESOGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalse1999-08-12DESOGESTREL AND ETHINYL ESTRADIOL
2ANDA075256_002RXETHINYL ESTRADIOL (0.03MG), DESOGESTREL (0.15MG)TABLETFalseAB1999-08-12DESOGESTREL AND ETHINYL ESTRADIOL
3ANDA075863_001RXETHINYL ESTRADIOL (0.02MG,0.01MG), DESOGESTREL (0.15MG,N/A)TABLETTrueAB2002-04-05KARIVA
4ANDA076455_001RXETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG), DESOGESTREL (0.1MG,0.125MG,0.15MG)TABLETFalseAB2004-02-24VELIVET
5ANDA076675_001RXDESOGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2011-02-25EMOQUETTE
6ANDA076681_001RXDESOGESTREL (0.15MG,N/A), ETHINYL ESTRADIOL (0.02MG,0.01MG)TABLETFalseAB2015-04-30KIMIDESS
7ANDA076915_001RXDESOGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2005-07-29DESOGESTREL AND ETHINYL ESTRADIOL
8ANDA076916_001RXDESOGESTREL (0.15MG,N/A), ETHINYL ESTRADIOL (0.02MG,0.01MG)TABLETFalseAB2008-12-29DESOGESTREL AND ETHINYL ESTRADIOL
9ANDA077182_001RXDESOGESTREL (0.1MG,0.125MG,0.15MG), ETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG)TABLETFalseAB2006-01-24DESOGESTREL AND ETHINYL ESTRADIOL
10ANDA091234_001RXDESOGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2013-07-12DESOGESTREL AND ETHINYL ESTRADIOL
11ANDA091247_001RXETHINYL ESTRADIOL (0.02MG,0.01MG), DESOGESTREL (0.15MG,N/A)TABLETFalseAB2013-08-01PIMTREA
12ANDA091346_001RXETHINYL ESTRADIOL (0.02MG,0.01MG), DESOGESTREL (0.15MG,N/A)TABLETFalseAB2012-04-02VIORELE
13ANDA201887_001RXDESOGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2013-03-07ENSKYCE
14ANDA202085_001RXDESOGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalseAB2015-05-20DESOGESTREL AND ETHINYL ESTRADIOL
15ANDA202226_001RXDESOGESTREL (0.15MG,N/A), ETHINYL ESTRADIOL (0.02MG,0.01MG)TABLETFalseAB2015-08-12BEKYREE
16ANDA202296_001RXETHINYL ESTRADIOL (0.02MG,0.01MG), DESOGESTREL (0.15MG,N/A)TABLETFalseAB2013-08-30DESOGESTREL AND ETHINYL ESTRADIOL
17ANDA202789_001RXETHINYL ESTRADIOL (0.03MG), DESOGESTREL (0.15MG)TABLETFalseAB2015-08-12ISIBLOOM
18NDA020071_001discontinuedETHINYL ESTRADIOL (0.03MG), DESOGESTREL (0.15MG)TABLETFalse1992-12-10DESOGEN
19NDA020071_002RXETHINYL ESTRADIOL (0.03MG), DESOGESTREL (0.15MG)TABLETFalseAB1992-12-10DESOGEN
20NDA020301_001discontinuedDESOGESTREL (0.15MG), ETHINYL ESTRADIOL (0.03MG)TABLETFalse1992-12-14ORTHO-CEPT
21NDA020301_002RXETHINYL ESTRADIOL (0.03MG), DESOGESTREL (0.15MG)TABLETTrueAB1992-12-14ORTHO-CEPT
22NDA020713_001discontinuedETHINYL ESTRADIOL (0.02MG,0.01MG), DESOGESTREL (0.15MG,N/A)TABLETFalse1998-04-22MIRCETTE
23NDA021090_001RXDESOGESTREL (0.1MG,0.125MG,0.15MG), ETHINYL ESTRADIOL (0.025MG,0.025MG,0.025MG)TABLETTrueAB2000-12-20CYCLESSA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1145f757f-c900-4aee-a862-b0ad60e64ed6 (view SPL)DESOGEN TabletsprescriptionHuman PrescriptionOrganon Usa Inc.API MANUFACTURE, MANUFACTURE, PACK2014-06-167000520261
23b46d7d9-6ed5-4bf0-86d1-9798df6a20a2 (view SPL)Cyred (Desogestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg)prescriptionHuman PrescriptionAfaxys Inc.analysis, label, manufacture, pack2015-08-282501020154
3a7140182-a0ac-485e-929c-6e05092c2ae5 (view SPL)ORTHO-CEPT TABLETS (DESOGESTREL AND ETHINYL ESTRADIOL)prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.API Manufacture, Analysis, Manufacture2013-10-223504580196
4ac92c9d8-8fbb-494d-81fc-21c55148dbc4 (view SPL)Desogestrel and Ethinyl Estradiol Tablets, USP, 0.15 mg /0.03 mgprescriptionHuman PrescriptionNorthstar Rx LlcMANUFACTURE2014-05-304167140367
5fa4fcf86-c79b-4745-ade7-0df01e04eba0 (view SPL)EMOQUETTE(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP) 0.15 mg and 0.03 mgRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-07-281617860382

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