Ethinyl Estradiol / Etonogestrel Vaginal Ring

Brand(s)
NuvaRing
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Organon Usa Inc. (2014-11-07)
Oldest Current Product
2001-10-03
License(s)
NDA
RxNORM
VAGINAL RING\ETHINYL ESTRADIOL:ETONOGESTREL
FDAOB
VAGINAL\RING\ETHINYL ESTRADIOL: ETONOGESTREL
SPL Active
VAGINAL\INSERT, EXTENDED RELEASE\ETHINYL ESTRADIOL: ETONOGESTREL
SPL Moiety
VAGINAL\INSERT, EXTENDED RELEASE\ETHINYL ESTRADIOL: ETONOGESTREL

product(s) by strength(s)

21 day ethinyl estradiol 0.000625 mg/hr / etonogestrel 0.005 mg/hr vaginal ring

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000520273NuvaRingNDAOrganon Usa Inc.2001-10-03ETHINYL ESTRADIOL, ETONOGESTRELVAGINALINSERT, EXTENDED RELEASENDA021187017343fb-86c4-45ab-9c47-52cc5b9f3a02

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684832NuvaRingNDAPhysicians Total Care, Inc.2011-11-04ETHINYL ESTRADIOL, ETONOGESTRELVAGINALINSERT, EXTENDED RELEASE000520273NDA0211877e6f14df-1ce5-43fa-ad21-90bc4d74bc6c

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021187NUVARINGORGANON USA INC2001-10-03p5989581NDA021187_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021187_001RXETONOGESTREL (0.12MG/24HR), ETHINYL ESTRADIOL (0.015MG/24HR)VAGINALRINGTrue2001-10-03NUVARING

patent(s)

#idexpiration dateapplication(s)
1p5989581 (view patent)2018-04-08NDA021187

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1017343fb-86c4-45ab-9c47-52cc5b9f3a02 (view SPL)These highlights do not include all the information needed to use NuvaRing safely and effectively. See full prescribing information for NuvaRing. NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)Initial U.S. Approval: 2001prescriptionHuman PrescriptionOrganon Usa Inc.API MANUFACTURE, MANUFACTURE, PACK2014-11-0713000520273
27e6f14df-1ce5-43fa-ad21-90bc4d74bc6c (view SPL)NUVARING (etonogestrel/ethinyl estradiol vaginal ring)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-02-092548684832

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