FDA.reportPublic FDA data

Application 087916

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4183DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4183DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4183DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-4183DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4183DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8176DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8176DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8176DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8176DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
21695-745DexamethasoneDexamethasoneRebel Distributors CorpANDACurrent
43063-266DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-266DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-266DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-266DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-266DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-266DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55154-4914DexamethasoneDexamethasoneCardinal HealthANDACurrent
55154-4914DexamethasoneDexamethasoneCardinal Health 107, LLCANDACurrent
55154-4914DexamethasoneDexamethasoneCardinal HealthANDACurrent
63187-383DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-383DexamethasoneDexamethasoneProficient Rx LPANDACurrent
69306-112DexamethasoneDexamethasoneDoc RxANDACurrent
69306-112DexamethasoneDexamethasoneDoc RxANDACurrent
69306-112DexamethasoneDexamethasoneDoc RxANDACurrent
69306-112DexamethasoneDexamethasoneDoc RxANDACurrent
70518-3050DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent