FDA.reportPublic FDA data

Application 021985

Type
NDA
Sponsor
NODEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEKTURNAALISKIREN HEMIFUMARATETABLET;ORALEQ 150MG BASEYesNo
002TEKTURNAALISKIREN HEMIFUMARATETABLET;ORALEQ 300MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1250Tekturnaaliskiren hemifumarateA-S Medication SolutionsNDACurrent
50090-2985Tekturnaaliskiren hemifumarateA-S Medication SolutionsNDACurrent
50090-2985Tekturnaaliskiren hemifumarateA-S Medication SolutionsNDACurrent
66993-141Aliskirenaliskiren hemifumaratePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-141Aliskirenaliskiren hemifumaratePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-141Aliskirenaliskiren hemifumaratePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-142Aliskirenaliskiren hemifumaratePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-142Aliskirenaliskiren hemifumaratePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-142Aliskirenaliskiren hemifumaratePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70839-150Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-150Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-150Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-150Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-150Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-300Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-300Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-300Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-300Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent
70839-300Tekturnaaliskiren hemifumarateNoden Pharma USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63673SUPPL2020-06-23
63624SUPPL2020-06-19
50518SUPPL2017-11-29
50422SUPPL2017-11-15
45832SUPPL2016-11-18
45851SUPPL2016-11-08
53028SUPPL2016-08-09
53027SUPPL2016-08-09
53026SUPPL2016-08-09
52974SUPPL2016-08-09
16692SUPPL2015-12-28
6590SUPPL2015-12-23
37997SUPPL2015-04-02
6589SUPPL2015-04-01
37996SUPPL2014-03-19
6588SUPPL2013-11-07
37995SUPPL2013-11-04
44165ORIG2012-11-23
28979SUPPL2012-10-02
37994SUPPL2012-10-01
52973SUPPL2012-08-06
28978SUPPL2012-04-18
37993SUPPL2012-04-16
28977SUPPL2012-02-07
37992SUPPL2012-02-06
37991SUPPL2012-01-31
28976SUPPL2012-01-31
16691SUPPL2011-10-20
6587SUPPL2011-10-17
28975SUPPL2011-02-14
37990SUPPL2011-02-11
6586SUPPL2010-08-10
16690SUPPL2010-08-04
6585SUPPL2010-01-25
16689SUPPL2009-11-16
52971SUPPL2009-03-13
28974SUPPL2008-05-21
52975SUPPL2008-05-13
6584SUPPL2008-02-20
28973SUPPL2007-08-14
42368ORIG2007-04-30
28972ORIG2007-03-15
16688ORIG2007-03-07
63847ORIG1900-01-01