FDA.reportPublic FDA data

Application 088306

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4181DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4181DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4181DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-4181DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4181DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8174DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8174DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8174DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8174DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0121-0907DexamethasoneDexamethasonePharmaceutical Associates, Inc.ANDACurrent
0121-1814DexamethasoneDexamethasonePharmaceutical Associates, Inc.ANDACurrent
0121-1814DexamethasoneDexamethasonePharmaceutical Associates, Inc.ANDACurrent
21695-728DexamethasoneDexamethasoneRebel Distributors CorpANDACurrent
63629-7850DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
63629-7850DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
63629-7850DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
69306-111DexamethasoneDexamethasoneDoc RxANDACurrent
69306-111DexamethasoneDexamethasoneDoc RxANDACurrent
69306-111DexamethasoneDexamethasoneDoc RxANDACurrent
69306-111DexamethasoneDexamethasoneDoc RxANDACurrent