FDA.reportPublic FDA data

Application 018533

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIZORALKETOCONAZOLETABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81301SUPPL 2025-02-20
11231SUPPL2014-03-05
15025SUPPL2014-02-27
44023ORIG2014-02-07
939SUPPL2013-07-29
43609ORIG2013-07-25
33503SUPPL2013-07-25