FDA.reportPublic FDA data

Application 021187

Type
NDA
Sponsor
ORGANON SUB MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUVARINGETHINYL ESTRADIOL; ETONOGESTRELRING;VAGINAL0.015MG/24HR;0.12MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0052-0273NuvaRingetonogestrel and ethinyl estradiolOrganon USA Inc.NDACurrent
0052-0273NuvaRingetonogestrel and ethinyl estradiolOrganon USA Inc.NDACurrent
0052-0273NuvaRingetonogestrel and ethinyl estradiolOrganon USA Inc.NDACurrent
50090-1008NUVARINGetonogestrel and ethinyl estradiolA-S Medication SolutionsNDACurrent
50090-1008NUVARINGetonogestrel and ethinyl estradiolA-S Medication SolutionsNDACurrent
50090-5611NUVARINGetonogestrel and ethinyl estradiolA-S Medication SolutionsNDACurrent
50090-5959Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
66993-605Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-605Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-605Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-605Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-605Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-605Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-605Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
76413-131NuvaRingetonogestrel and ethinyl estradiolCentral Texas Community Health CentersNDACurrent
78206-146NuvaRingetonogestrel and ethinyl estradiolOrganon LLCNDACurrent
78206-146NuvaRingetonogestrel and ethinyl estradiolOrganon LLCNDACurrent
78206-146NuvaRingetonogestrel and ethinyl estradiolOrganon LLCNDACurrent
78206-146NuvaRingetonogestrel and ethinyl estradiolOrganon LLCNDACurrent
78206-146NuvaRingetonogestrel and ethinyl estradiolOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78624SUPPL 2024-06-04
78611SUPPL 2024-06-03
70933SUPPL2022-05-03
70902SUPPL2022-05-02
58693SUPPL2019-05-14
58660SUPPL2019-05-13
56653SUPPL2018-12-07
56652SUPPL2018-12-07
56636SUPPL2018-12-06
56635SUPPL2018-12-06
52768SUPPL2018-02-28
52639SUPPL2018-02-14
52626SUPPL2018-02-14
49374SUPPL2017-08-15
49308SUPPL2017-08-10
48626SUPPL2017-06-02
48613SUPPL2017-06-01
45583SUPPL2016-10-06
45470SUPPL2016-10-04
21498SUPPL2015-04-06
42012SUPPL2015-03-10
44639SUPPL2015-01-09
24186SUPPL2015-01-09
14610SUPPL2014-11-07
27025SUPPL2014-11-03
14609SUPPL2014-06-23
4602SUPPL2014-06-19
4601SUPPL2013-10-21
4600SUPPL2013-10-21
36316SUPPL2013-10-08
14608SUPPL2013-10-08
4599SUPPL2008-05-05
27024SUPPL2007-10-04
14607SUPPL2007-10-04
36315SUPPL2005-08-03
27023SUPPL2005-08-03
4598SUPPL2004-03-10
4597SUPPL2004-03-02
42011ORIG2001-10-03
36314ORIG2001-10-03
4596ORIG2001-10-03