FDA.reportPublic FDA data

Application 019927

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIZORALKETOCONAZOLESHAMPOO;TOPICAL2%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10147-0750KETOCONAZOLEketoconazolePatriot Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
10147-0750KETOCONAZOLEketoconazolePatriot Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
50458-680NizoralketoconazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-680NizoralketoconazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-680NizoralketoconazoleJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23562ORIG2014-02-07
11852SUPPL2013-10-31
19846SUPPL2013-10-30
19845SUPPL2012-12-05
11851SUPPL2012-12-05
34102SUPPL2009-09-17