FDA.reportPublic FDA data

Application 203445

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ITRACONAZOLEITRACONAZOLECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59746-282itraconazoleItraconazole CapsulesJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-282itraconazoleItraconazole CapsulesJubilant Cadista Pharmaceuticals Inc.ANDACurrent