FDA.reportPublic FDA data

Application 013174

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DYRENIUMTRIAMTERENECAPSULE;ORAL50MGYesNo
002DYRENIUMTRIAMTERENECAPSULE;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59212-002DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-002DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-002DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-002DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-002DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-003DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-003DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-003DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-003DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
59212-003DyreniumTriamtereneConcordia Pharmaceuticals Inc.NDACurrent
65197-002DyreniumTriamtereneWellSpring Pharmaceutical CorporationNDACurrent
65197-003DyreniumTriamtereneWellSpring Pharmaceutical CorporationNDACurrent
66993-831triamtereneTriamterenePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-831triamtereneTriamterenePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-831triamtereneTriamterenePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-831triamtereneTriamterenePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-832TriamtereneTriamterenePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-832TriamtereneTriamterenePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-832TriamtereneTriamterenePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-832TriamtereneTriamterenePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
68151-1494DyreniumTriamtereneCarilion Materials ManagementNDACurrent