FDA.reportPublic FDA data

Application 022511

Type
NDA
Sponsor
HORIZON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIMOVOESOMEPRAZOLE MAGNESIUM; NAPROXENTABLET, DELAYED RELEASE;ORALEQ 20MG BASE;500MGYesYes
002VIMOVOESOMEPRAZOLE MAGNESIUM; NAPROXENTABLET, DELAYED RELEASE;ORALEQ 20MG BASE;375MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70748-215NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUMLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70748-215NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUMLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70748-215NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUMLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70748-215NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUMLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70748-216NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUMLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70748-216NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUMLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70748-216NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUMLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70748-216NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNAPROXEN AND ESOMEPRAZOLE MAGNESIUMLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
75987-030VimovoNaproxen and Esomeprazole MagnesiumHorizon Therapeutics USA, Inc.NDACurrent
75987-030VimovoNaproxen and Esomeprazole MagnesiumHorizon Therapeutics USA, Inc.NDACurrent
75987-030VimovoNaproxen and Esomeprazole MagnesiumHorizon Pharma Inc.NDACurrent
75987-030VimovoNaproxen and Esomeprazole MagnesiumHorizon Medicines LLCNDACurrent
75987-030VimovoNaproxen and Esomeprazole MagnesiumHorizon Therapeutics USA, Inc.NDACurrent
75987-030VimovoNaproxen and Esomeprazole MagnesiumHorizon Therapeutics USA, Inc.NDACurrent
75987-031VimovoNaproxen and Esomeprazole MagnesiumHorizon Therapeutics USA, Inc.NDACurrent
75987-031VimovoNaproxen and Esomeprazole MagnesiumHorizon Therapeutics USA, Inc.NDACurrent
75987-031VimovoNaproxen and Esomeprazole MagnesiumHorizon Therapeutics USA, Inc.NDACurrent
75987-031VimovoNaproxen and Esomeprazole MagnesiumHorizon Medicines LLCNDACurrent
75987-031VimovoNaproxen and Esomeprazole MagnesiumHorizon Pharma Inc.NDACurrent
75987-031VimovoNaproxen and Esomeprazole MagnesiumHorizon Therapeutics USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80412SUPPL 2024-11-25
80411SUPPL 2024-11-25
80311SUPPL 2024-11-22
74823SUPPL 2023-07-20
74782SUPPL 2023-07-19
70449SUPPL2022-03-09
70444SUPPL2022-03-09
70429SUPPL2022-03-07
67368SUPPL2021-05-03
67367SUPPL2021-05-03
67277SUPPL2021-04-30
65396SUPPL2020-11-30
65395SUPPL2020-11-30
65388SUPPL2020-11-30
59446SUPPL2019-07-25
59408SUPPL2019-07-23
59407SUPPL2019-07-23
54582SUPPL2018-06-14
54528SUPPL2018-06-12
54527SUPPL2018-06-12
48937SUPPL2017-07-10
48928SUPPL2017-07-07
45727SUPPL2016-11-10
45651SUPPL2016-11-10
17663SUPPL2016-05-11
7477SUPPL2016-05-10
38784SUPPL2015-06-23
7476SUPPL2015-06-23
38783SUPPL2015-05-08
29803SUPPL2015-03-26
38785SUPPL2014-12-29
29804SUPPL2014-12-23
38782SUPPL2014-04-01
7475SUPPL2014-03-28
29802SUPPL2014-02-27
17662SUPPL2014-02-27
17661SUPPL2012-10-12
29801SUPPL2012-10-11
17660SUPPL2012-10-04
29800SUPPL2012-10-03
38781SUPPL2012-01-24
7474SUPPL2012-01-23
23711ORIG2011-12-20
38778SUPPL2011-11-29
29797SUPPL2011-11-22
38779SUPPL2011-06-29
29798SUPPL2011-06-29
17659SUPPL2011-06-29
7473SUPPL2011-06-29
38780SUPPL2011-05-26
29799SUPPL2011-05-25
44766ORIG2011-02-28
22041ORIG2011-02-28
38777ORIG2010-05-07
7472ORIG2010-05-07
51398ORIG1900-01-01
51397ORIG1900-01-01