FDA.report

Application 084612

Type
ANDA
Sponsor
HIKMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL4MGNoNo
002DEXAMETHASONEDEXAMETHASONETABLET;ORAL0.5MGYesNo
003DEXAMETHASONEDEXAMETHASONETABLET;ORAL0.75MGYesNo
004DEXAMETHASONEDEXAMETHASONETABLET;ORAL1MGYesYes
005DEXAMETHASONEDEXAMETHASONETABLET;ORAL1.5MGYesNo
006DEXAMETHASONEDEXAMETHASONETABLET;ORAL2MGYesYes
007DEXAMETHASONEDEXAMETHASONETABLET;ORAL6MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4184DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4184DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4184DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-4184DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4184DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8175DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-8175DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8175DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8175DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
21695-382DexamethasoneDexamethasoneRebel Distributors CorpANDACurrent
45865-989DexamethasoneDexamethasonemedsource pharmaceuticalsANDACurrent
49999-059DexamethasoneDexamethasoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-059DexamethasoneDexamethasoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-059DexamethasoneDexamethasoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-059DexamethasoneDexamethasoneLake Erie Medical DBA QuaANDACurrent
50090-0088DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0088DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0088DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0088DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0089DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0089DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0089DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0089DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
51407-361DexamethasoneDexamethasoneGolden State Medical SupplyANDACurrent
51407-361DexamethasoneDexamethasoneGolden State Medical SupplyANDACurrent
51407-361DexamethasoneDexamethasoneGolden State Medical Supply, Inc.ANDACurrent
51655-012DexamethsoneDexamethasoneNorthwind Pharmaceuticals, LLCANDACurrent
53217-374DexamethasoneDexamethasoneAidarex Pharmaceuticals LLCANDACurrent
55154-4901DexamethasoneDexamethasoneCardinal HealthANDACurrent
55154-4901DexamethasoneDexamethasoneCardinal Health 107, LLCANDACurrent
55154-4901DexamethasoneDexamethasoneCardinal HealthANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, InANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63629-3742DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
63629-3742DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
66336-479DexamethasoneDexamethasoneDispensing Solutions, Inc.ANDACurrent
67296-0326DexamethasoneDexamethasoneRedPharm DrugANDACurrent
67296-0326DexamethasoneDexamethasoneRedPharm DrugANDACurrent
67296-0326DexamethasoneDexamethasoneRedPharm DrugANDACurrent
68071-2321DexamethasoneDexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2321DexamethasoneDexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
69306-114DexamethasoneDexamethasoneDoc RxANDACurrent
69306-114DexamethasoneDexamethasoneDoc RxANDACurrent
69306-114DexamethasoneDexamethasoneDoc RxANDACurrent
70518-1534DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent
70518-1534DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent
70518-1534DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent
70518-1534DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent
72189-254DEXAMETHASONEDEXAMETHASONEDirect RxANDACurrent