FDA.reportPublic FDA data

Application 088810

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONE INTENSOLPREDNISONESOLUTION;ORAL5MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3721PredniSONE IntensolPredniSONE IntensolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3721PredniSONE IntensolPredniSONE IntensolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3721PredniSONE IntensolPredniSONE IntensolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3721PredniSONE IntensolPredniSONE IntensolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3721PredniSONE IntensolPredniSONE IntensolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3721PredniSONE IntensolPredniSONE IntensolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3721PredniSONE IntensolPredniSONE IntensolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3721PredniSONE IntensolPredniSONE IntensolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3721PredniSONE IntensolPredniSONE IntensolHikma Pharmaceuticals USA Inc.ANDACurrent