FDA.reportPublic FDA data

Application 018738

Type
NDA
Sponsor
JOURNEY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXELDERMSULCONAZOLE NITRATESOLUTION;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10631-100Exeldermsulconazole nitrateSun Pharmaceutical Industries, Inc.NDACurrent
10631-100Exeldermsulconazole nitrateSun Pharmaceutical Industries, Inc.NDACurrent
69489-721ExeldermSulconazole NitrateJourney Medical CorporationNDACurrent
69489-721ExeldermSulconazole NitrateJourney Medical CorporationNDACurrent
69489-721ExeldermSulconazole NitrateJourney Medical CorporationNDACurrent
72143-321Sulconazole NitrateSulconazole NitrateJG Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57620ORIG2019-02-15
1059SUPPL2009-07-13
11313SUPPL2009-07-09
16021SUPPL2003-06-08
11312SUPPL2003-06-08