FDA.reportPublic FDA data

Application 084610

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4182DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4182DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4182DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4182DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-4182DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8181DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8181DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8181DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8181DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
61919-827DEXAMETHASONEDEXAMETHASONEDirect RxANDACurrent
61919-827DEXAMETHASONEDEXAMETHASONEDirect RxANDACurrent
63629-4127DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
63629-4127DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent