FDA.reportPublic FDA data

Application 088248

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONESOLUTION;ORAL0.5MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3177DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3177DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3177DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3177DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-3177DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
63629-2696DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent