FDA.reportPublic FDA data

Application 022107

Type
NDA
Sponsor
NODEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEKTURNA HCTALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDETABLET;ORALEQ 150MG BASE;12.5MGYesNo
002TEKTURNA HCTALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDETABLET;ORALEQ 150MG BASE;25MGYesNo
003TEKTURNA HCTALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDETABLET;ORALEQ 300MG BASE;12.5MGYesYes
004TEKTURNA HCTALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDETABLET;ORALEQ 300MG BASE;25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70839-112Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-112Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-112Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-112Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-112Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-125Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-125Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-125Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-125Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-125Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-312Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-312Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-312Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-312Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-312Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-325Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-325Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-325Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-325Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent
70839-325Tekturna HCTaliskiren hemifumarate and hydrochlorothiazideNoden Pharma USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64776SUPPL2020-10-01
64768SUPPL2020-10-01
45853SUPPL2016-11-08
45831SUPPL2016-11-08
38259SUPPL2015-12-28
29258SUPPL2015-12-23
16951SUPPL2015-04-02
29257SUPPL2015-04-01
16950SUPPL2014-03-19
6903SUPPL2013-11-07
38258SUPPL2013-11-04
6902SUPPL2012-10-02
16949SUPPL2012-10-01
6901SUPPL2012-04-18
38257SUPPL2012-04-16
38255SUPPL2012-02-17
6898SUPPL2012-02-17
6900SUPPL2012-02-14
38256SUPPL2012-01-31
6899SUPPL2012-01-30
16948SUPPL2011-10-20
6897SUPPL2011-10-14
38254SUPPL2011-06-16
6896SUPPL2011-06-16
6895SUPPL2011-02-14
38253SUPPL2011-02-11
29256SUPPL2010-08-11
16947SUPPL2010-08-09
38252SUPPL2010-05-28
6894SUPPL2010-05-24
16946SUPPL2009-07-24
6893SUPPL2009-07-17
44680ORIG2008-10-27
42416ORIG2008-10-27
29255SUPPL2008-07-23
38251ORIG2008-01-23
6892ORIG2008-01-23