FDA.reportPublic FDA data

Application 021956

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUTOPROLHYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORAL12.5MG;EQ 25MG TARTRATEYesNo
002DUTOPROLHYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORAL12.5MG;EQ 50MG TARTRATEYesNo
003DUTOPROLHYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORAL12.5MG;EQ 100MG TARTRATEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59212-087Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-087Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-087Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-087Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-087Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-087Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-087Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-095Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-095Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-095Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-095Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-095Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-095Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-095Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-097Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-097Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-097Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-097Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-097Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-097Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
59212-097Dutoprolmetoprolol succinate and hydrochlorothiazideConcordia Pharmaceuticals Inc.NDACurrent
69499-321metoprolol succinate and hydrochlorothiazidemetoprolol succinate and hydrochlorothiazideSolubiomixNDACurrent
69499-321metoprolol succinate and hydrochlorothiazidemetoprolol succinate and hydrochlorothiazideSolubiomixNDACurrent
69499-323metoprolol succinate and hydrochlorothiazidemetoprolol succinate and hydrochlorothiazideSolubiomixNDACurrent
69499-323metoprolol succinate and hydrochlorothiazidemetoprolol succinate and hydrochlorothiazideSolubiomixNDACurrent
69499-324metoprolol succinate and hydrochlorothiazidemetoprolol succinate and hydrochlorothiazideSolubiomixNDACurrent
69499-324metoprolol succinate and hydrochlorothiazidemetoprolol succinate and hydrochlorothiazideSolubiomixNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69922SUPPL2022-01-19
69896SUPPL2022-01-18
64428SUPPL2020-08-27
64358SUPPL2020-08-21
49491SUPPL2017-08-21
49439SUPPL2017-08-17
6539SUPPL2014-10-22
37947SUPPL2014-10-21
6538SUPPL2011-12-22
37946SUPPL2011-12-19
37945SUPPL2011-03-07
28913SUPPL2011-03-07
16636SUPPL2011-03-07
6537SUPPL2011-03-07
21884ORIG2008-05-07
6536ORIG2006-09-18
37944ORIG2006-08-29