FDA.reportPublic FDA data

Application 018737

Type
NDA
Sponsor
JOURNEY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10631-101Exeldermsulconazole nitrateSun Pharmaceutical Industries, Inc.NDACurrent
69489-711ExeldermSulconazole NitrateJourney Medical CorporationNDACurrent
69489-711ExeldermSulconazole NitrateJourney Medical CorporationNDACurrent
72143-311Sulconazole NitrateSulconazole NitrateJG PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11311SUPPL2003-06-08
1058SUPPL2003-06-08