FDA.reportPublic FDA data

Application 208398

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERMOXMEBENDAZOLETABLET, CHEWABLE;ORAL500MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-675VERMOXmebendazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-675VERMOXmebendazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-675VERMOXmebendazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-675VERMOXmebendazoleJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68691SUPPL2021-09-21
46615ORIG2016-12-30
46614ORIG2016-12-30
45686ORIG2016-10-27
45628ORIG2016-10-21