FDA.reportPublic FDA data

Application 088252

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONE INTENSOLDEXAMETHASONECONCENTRATE;ORAL1MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3176Dexamethasone IntensolDexamethasone IntensolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3176Dexamethasone IntensolDexamethasone IntensolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3176Dexamethasone IntensolDexamethasone IntensolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3176Dexamethasone IntensolDexamethasone IntensolHikma Pharmaceuticals USA, Inc.ANDACurrent
68151-5026Dexamethasone IntensolDexamethasone IntensolCarilion Materials ManagementANDACurrent