FDA.reportPublic FDA data

Application 084122

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0017PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0017PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0017PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0017PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0017PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0017PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0017PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0017PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0017PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9817PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9817PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9817PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9817PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9817PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0615-3593PrednisonePrednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-3593PrednisonePrednisoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-3593PrednisonePrednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-3593PrednisonePrednisoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8391PredniSONEPredniSONENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8391PredniSONEPredniSONENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8391PredniSONEPredniSONENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-093PredniSONEPredniSONEBlenheim Pharmacal, Inc.ANDACurrent
42708-045PredniSONEPredniSONEQPharma IncANDACurrent
42708-045PredniSONEPredniSONEQPharma IncANDACurrent
42708-045PredniSONEPredniSONEQPharma IncANDACurrent
51407-358PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-358PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-358PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51407-358PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51655-726PredniSONEPredniSONENorthwind Pharmaceuticals, LLCANDACurrent
55154-4949PredniSONEPredniSONECardinal Health 107, LLCANDACurrent
55154-4949PredniSONEPredniSONECardinal HealthANDACurrent
55154-4949PredniSONEPredniSONECardinal HealthANDACurrent
55154-4949PredniSONEPredniSONECardinal HealthANDACurrent
55154-4949PredniSONEPredniSONECardinal HealthANDACurrent
55154-4949PredniSONEPredniSONECardinal HealthANDACurrent
63629-6621PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
63629-7388PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
63629-7388PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
66336-058PredniSONEPredniSONEDispensing Solutions, Inc.ANDACurrent
66336-058PredniSONEPredniSONEDispensing Solutions, Inc.ANDACurrent
70934-291PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-291PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-291PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-831PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-831PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-831PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent