FDA.reportPublic FDA data

Application 088703

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONESOLUTION;ORAL5MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3722PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3722PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3722PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3722PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3722PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3722PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3722PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3722PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3722PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
17856-3722PredniSONEPredniSONEAtlantic Biologicals CorpsANDACurrent
68151-0820PredniSONEPredniSONECarilion Materials ManagementANDACurrent