FDA.report

Application 080352

Type
ANDA
Sponsor
HIKMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL5MGNoYes
002PREDNISONEPREDNISONETABLET;ORAL1MGYesYes
003PREDNISONEPREDNISONETABLET;ORAL2.5MGYesYes
004PREDNISONEPREDNISONETABLET;ORAL10MGYesYes
005PREDNISONEPREDNISONETABLET;ORAL20MGYesYes
006PREDNISONEPREDNISONETABLET;ORAL50MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4728PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4728PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4728PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4728PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4728PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4728PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4728PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4728PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-4728PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8724PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8724PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8724PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8724PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8724PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8724PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8724PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-8724PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8724PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9828PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9828PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9828PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9828PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-9828PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0463-6155PredniSONEPredniSONEC.O. Truxton, Inc.ANDACurrent
0615-0536PredniSONEPredniSONENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-0536PredniSONEPrednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-0536PredniSONEPredniSONENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-0536PredniSONEPrednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-0536PredniSONEPrednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-0536PredniSONEPredniSONENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8395PrednisonePrednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8395PrednisonePrednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
42708-047PrednisonePrednisoneQPharma IncANDACurrent
42708-047PrednisonePrednisoneQPharma IncANDACurrent
43063-968PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-968PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-968PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-968PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-968PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-968PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-968PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-968PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-657PredniSONEPredniSONEAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-657PredniSONEPredniSONEAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
50436-4324PredniSONEPredniSONEUnit Dose ServicesANDACurrent
51407-357PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-357PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-357PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51407-357PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51655-355PredniSONEPredniSONENorthwind PharmaceuticalsANDACurrent
51655-355PredniSONEPredniSONENorthwind PharmaceuticalsANDACurrent
55154-4938PredniSONEPredniSONECardinal HealthANDACurrent
55154-4938PredniSONEPredniSONECardinal HealthANDACurrent
55154-4938PredniSONEPredniSONECardinal HealthANDACurrent
55154-4938PredniSONEPredniSONECardinal HealthANDACurrent
55154-4938PredniSONEPredniSONECardinal HealthANDACurrent
55154-4938PredniSONEPredniSONECardinal Health 107, LLCANDACurrent
63629-8119PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
63629-8119PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
67296-1704PredniSONEPredniSONERedPharm Drug, Inc.ANDACurrent
67296-1704PredniSONEPredniSONERedPharm Drug, Inc.ANDACurrent
68071-2509PredniSONEPredniSONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2578PredniSONEPredniSONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4862PredniSONEPredniSONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4862PredniSONEPredniSONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4903PredniSONEPredniSONENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4903PredniSONEPredniSONENuCare Pharmaceuticals,Inc.ANDACurrent
70518-1116PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-1116PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-2516PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-2516PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70934-290PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-290PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-290PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1220PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
71335-1220PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
71610-641PredniSONEPredniSONEAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0068PrednisonePrednisoneAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0068PrednisonePrednisoneAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent