FDA.reportPublic FDA data

Application 021852

Type
NDA
Sponsor
LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TACLONEXBETAMETHASONE DIPROPIONATE; CALCIPOTRIENEOINTMENT;TOPICAL0.064%;0.005%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-989Calcipotriene and Betamethasone Dipropionatecalcipotriene and betamethasone dipropionatePerrigo New York IncNDA AUTHORIZED Current
45802-989Calcipotriene and Betamethasone Dipropionatecalcipotriene and betamethasone dipropionatePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-989Calcipotriene and Betamethasone Dipropionatecalcipotriene and betamethasone dipropionatePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-989Calcipotriene and Betamethasone Dipropionatecalcipotriene and betamethasone dipropionatePerrigo New York IncNDA AUTHORIZED GENERICCurrent
50222-227Taclonexcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-227Taclonexcalcipotriene and betamethasone dipropionateLEO Pharma IncNDACurrent
50222-227Taclonexcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-227Taclonexcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-227Taclonexcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
66993-938Calcipotriene and Betamethasone DipropionateCalcipotriene and Betamethasone DipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-938Calcipotriene and Betamethasone DipropionateCalcipotriene and Betamethasone DipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-938Calcipotriene and Betamethasone DipropionateCalcipotriene and Betamethasone DipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57087SUPPL2018-12-31
57015SUPPL2018-12-26
16457SUPPL2015-01-08
6306SUPPL2014-12-30
16458SUPPL2014-07-29
6307SUPPL2014-07-29
28713SUPPL2012-12-04
37764SUPPL2012-12-03
37763SUPPL2010-04-04
6305SUPPL2010-04-02
42325ORIG2008-03-24
37762SUPPL2007-10-04
28712SUPPL2007-10-04
28711ORIG2006-01-20
37761ORIG2006-01-13
52078SUPPL1900-01-01
52077SUPPL1900-01-01