FDA.reportPublic FDA data

Application 021844

Type
NDA
Sponsor
LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESONATEDESONIDEGEL;TOPICAL0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10922-828DESONATEdesonideIntendis Inc.NDACurrent
50222-504DESONATEdesonideLEO Pharma Inc.NDACurrent
50222-504DESONATEdesonideLEO Pharma Inc.NDACurrent
50419-828DESONATEdesonideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-828DESONATEdesonideBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
16446SUPPL2014-07-24
6287SUPPL2014-07-24
16445SUPPL2010-01-12
6286SUPPL2010-01-05
42324ORIG2008-09-05
28697ORIG2006-10-23
16444ORIG2006-10-23