FDA.reportPublic FDA data

Application 084283

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0019PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0019PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0019PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0019PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0019PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0019PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0019PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0019PredniSONEPredniSONEWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0019PredniSONEPredniSONEHikma Pharmaceuticals USA Inc.ANDACurrent
50090-0102PredniSONEPredniSONEA-S Medication SolutionsANDACurrent
50090-0102PredniSONEPredniSONEA-S Medication SolutionsANDACurrent
50090-0102PredniSONEPredniSONEA-S Medication SolutionsANDACurrent
50090-0102PredniSONEPredniSONEA-S Medication SolutionsANDACurrent
51407-360PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51407-360PredniSONEPredniSONEGolden State Medical Supply, Inc.ANDACurrent
51407-360PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
51407-360PredniSONEPredniSONEGolden State Medical SupplyANDACurrent
55154-4950PredniSONEPredniSONECardinal HealthANDACurrent
55154-4950PredniSONEPredniSONECardinal HealthANDACurrent
55154-4950PredniSONEPredniSONECardinal HealthANDACurrent
55154-4950PredniSONEPredniSONECardinal HealthANDACurrent
55154-4950PredniSONEPredniSONECardinal HealthANDACurrent
55154-4950PredniSONEPredniSONECardinal Health 107, LLCANDACurrent
55289-330PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-330PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-330PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-330PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-330PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-330PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-330PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-330PredniSONEPredniSONEPD-Rx Pharmaceuticals, Inc.ANDACurrent
61919-226PREDNISONEPREDNISONEDIRECT RXANDACurrent
61919-226PREDNISONEPREDNISONEDIRECT RXANDACurrent
61919-995PREDNISONEPREDNISONEDirectRXANDACurrent
63187-243PredniSONEPredniSONEProficient Rx LPANDACurrent
63187-243PredniSONEPredniSONEProficient Rx LPANDACurrent
63187-243PredniSONEPredniSONEProficient Rx LPANDACurrent
63187-243PredniSONEPredniSONEProficient Rx LPANDACurrent
63629-4562PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
63629-4562PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
63629-6660PredniSONEPredniSONEBryant Ranch PrepackANDACurrent
67296-1194PredniSONEPredniSONERedPharm Drug, Inc.ANDACurrent
67296-1194PredniSONEPredniSONERedPharm Drug, Inc.ANDACurrent
67296-1194PredniSONEPredniSONERedPharm Drug, Inc.ANDACurrent
70518-0306PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-0306PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-0306PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-0306PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-0306PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70518-0306PredniSONEPredniSONEREMEDYREPACK INC.ANDACurrent
70934-137PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-137PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-137PredniSONEPredniSONEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent