FDA.report

Application 088316

Type
ANDA
Sponsor
HIKMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL6MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4186DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4186DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4186DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4186DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-4186DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8183DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8183DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8183DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8183DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
63629-7806DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
63629-7806DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
67296-1413DexamethasoneDexamethasoneRedPharm Drug, Inc.ANDACurrent
70518-2998DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent