FDA.reportPublic FDA data

Application 020405

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANOXINDIGOXINTABLET;ORAL0.0625MGYesNo
002LANOXINDIGOXINTABLET;ORAL0.125MGYesNo
003LANOXINDIGOXINTABLET;ORAL0.1875MGYesNo
004LANOXINDIGOXINTABLET;ORAL0.25MGYesYes
005LANOXINDIGOXINTABLET;ORAL0.375MGNoNo
006LANOXINDIGOXINTABLET;ORAL0.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7935DIGOXINDIGOXINNCS HealthCare of KY, Inc dba Vangard LabsNDA AUTHORIZED GENERICCurrent
49884-494DIGOXINDIGOXINPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-514DIGOXINDIGOXINPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
53808-1006DIGOXINDIGOXINState of Florida DOH Central PharmacyNDA AUTHORIZED GENERICCurrent
55154-6726LANOXINdigoxinCardinal HealthNDACurrent
59212-240LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-240LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-240LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-240LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-240LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-240LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-242LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-242LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-242LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-242LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-242LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-242LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-245LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-249LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-249LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-249LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-249LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-249LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
59212-249LANOXINdigoxinConcordia Pharmaceuticals Inc.NDACurrent
65084-455LANOXINdigoxinMckesson Rxpak IncNDACurrent
66267-078DIGOXINDIGOXINNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
66267-078DIGOXINDIGOXINNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
66267-443DIGOXINDIGOXINNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
66267-443DIGOXINDIGOXINNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3011DIGOXINDIGOXINNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3011DIGOXINDIGOXINNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70518-0298DIGOXINDIGOXINREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0338DIGOXINDIGOXINREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0848DIGOXINDIGOXINREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0848DIGOXINDIGOXINREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0913DIGOXINDIGOXINREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0913DIGOXINDIGOXINREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71610-019LANOXINdigoxinAphena Pharma Solutions - Tennessee, LLCNDACurrent
71610-019LANOXINdigoxinAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78312SUPPL 2024-04-30
78304SUPPL 2024-04-30
57815SUPPL2019-02-27
57799SUPPL2019-02-25
55337SUPPL2018-08-28
55301SUPPL2018-08-24
46136SUPPL2016-12-13
46020SUPPL2016-12-05
12542SUPPL2015-07-30
24916SUPPL2015-07-29
24915SUPPL2013-10-21
12541SUPPL2013-10-18
2485SUPPL2012-08-16
34607SUPPL2012-08-15
2486SUPPL2011-11-16
34608SUPPL2011-11-14
20635ORIG2010-03-03
2484SUPPL2010-02-17
34606SUPPL2010-02-16