FDA.reportPublic FDA data

Application 084613

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL0.75MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4180DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4180DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4180DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-4180DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4180DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8180DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8180DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8180DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8180DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
21695-290DexamethasoneDexamethasoneRebel Distributors CorpANDACurrent
53217-231DexamethasoneDexamethasoneAidarex Pharmaceuticals LLCANDACurrent
55289-903DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-903DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-903DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-903DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-903DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-903DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-903DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-4129DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
63629-4129DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
63629-4129DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
68788-7267DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7267DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7267DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7267DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7267DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
72189-383DexamethasoneDexamethasoneDirect_RxANDACurrent