FDA.reportPublic FDA data

Application 020554

Type
NDA
Sponsor
LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOVONEXCALCIPOTRIENECREAM;TOPICAL0.005%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50222-260DovonexCalcipotrieneLEO Pharma Inc.NDACurrent
50222-260DovonexCalcipotrieneLEO Pharma Inc.NDACurrent
50222-260DovonexCalcipotrieneLEO Pharma Inc.NDACurrent
50222-260DovonexCalcipotrieneLEO Pharma Inc.NDACurrent
50222-260DovonexCalcipotrieneLEO Pharma Inc.NDACurrent
66993-877CalcipotrieneCalcipotrienePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-877CalcipotrieneCalcipotrienePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-877CalcipotrieneCalcipotrienePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-877CalcipotrieneCalcipotrienePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70859-048NuDermRxPAK 60Dimethicone, CalcipotrieneNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
70859-049NuDermRxPAK 120Dimethicone, CalcipotrieneNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
70859-055NuDermRxPAK 60Calcipotriene, DimethiconeNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
70859-055NuDermRxPAK 60Calcipotriene, DimethiconeNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
70859-056NuDermRxPAK 120Calcipotriene, DimethiconeNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
70859-056NuDermRxPAK 120Calcipotriene, DimethiconeNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83682SUPPL 2025-10-07
83672SUPPL 2025-10-06
34818SUPPL2015-03-17
2715SUPPL2015-03-13
34817SUPPL2007-10-04
2714SUPPL2007-10-04
34816SUPPL2005-05-02
25161SUPPL2005-05-02