FDA.reportPublic FDA data

Application 020273

Type
NDA
Sponsor
LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOVONEXCALCIPOTRIENEOINTMENT;TOPICAL0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66993-878calcipotrienecalcipotrienePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-878calcipotrienecalcipotrienePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-878calcipotrienecalcipotrienePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-878calcipotrienecalcipotrienePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-878calcipotrienecalcipotrienePrasco LaboratoriesNDA AUTHORIZED Current

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83681SUPPL 2025-10-07
83671SUPPL 2025-10-06
12410SUPPL2015-03-17
2285SUPPL2015-03-13
41263SUPPL2009-01-12
12409SUPPL2007-10-04
2284SUPPL2007-10-04
34461SUPPL2005-05-02
24715SUPPL2005-05-02
20582SUPPL1999-07-07
2283SUPPL1999-07-07