FDA.reportPublic FDA data

Application 087342

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL20MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0018PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0018PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0018PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0018PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0018PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0018PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0018PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0018PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0018PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9818PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9818PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9818PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9818PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9818PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0463-6141PredniSONEPredniSONEC.O. Truxton, Inc.ANDACurrent
0615-1542PredniSONEPredniSONENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8307PredniSONEPredniSONENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8307PredniSONEPredniSONENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8307PredniSONEPredniSONENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8307PredniSONEPredniSONENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-125PredniSONEPredniSONEBlenheim Pharmacal, Inc.ANDACurrent
35356-818PredniSONEPredniSONELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-818PredniSONEPredniSONELake Erie Medical DBA QuaANDACurrent
51407-359PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-359PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-359PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51407-359PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51655-701PredniSONEPredniSONENorthwind Pharmaceuticals, LLCANDACurrent
55154-4946PredniSONEPredniSONECardinal HealthANDACurrent
55154-4946PredniSONEPredniSONECardinal HealthANDACurrent
55154-4946PredniSONEPredniSONECardinal HealthANDACurrent
55154-4946PredniSONEPredniSONECardinal HealthANDACurrent
55154-4946PredniSONEPredniSONECardinal Health 107, LLCANDACurrent
55154-4946PredniSONEPredniSONECardinal HealthANDACurrent
55695-015PredniSONEPredniSONEDepartment of State Health Services, Pharmacy BranchANDACurrent
67296-0247PredniSONEPredniSONERedPharm Drug, Inc.ANDACurrent
67296-0247PredniSONEPredniSONERedPharm Drug, Inc.ANDACurrent
67296-0247PredniSONEPredniSONERedPharm Drug, Inc.ANDACurrent
68788-7453PredniSONEPredniSONEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7453PredniSONEPredniSONEPreferred Pharmaceuticals, Inc.ANDACurrent
69668-220DeltasonePredniSONESonoma Pharmaceuticals, Inc.ANDACurrent
70518-1105PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-1105PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-1553PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-1553PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-1553PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-2138PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-2138PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-2138PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-2138PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-2138PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70934-307PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-307PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-307PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent