FDA.reportPublic FDA data

Application 087801

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL2.5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4742PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4742PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4742PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4742PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4742PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4742PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4742PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4742PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4742PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8740PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8740PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8740PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8740PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8740PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8740PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8740PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8740PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8740PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0615-2513PredniSONEPredniSONENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50090-1455PredniSONEPredniSONEA-S Medication SolutionsANDACurrent
51407-356PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-356PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-356PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51407-356PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
66336-219PredniSONEPredniSONEDispensing Solutions, Inc.ANDACurrent
70934-365PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-365PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-365PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent