FDA.reportPublic FDA data

Application 040401

Type
ANDA
Sponsor
HI TECH PHARMA CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISOLONEPREDNISOLONESYRUP;ORAL15MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-686PrednisolonePrednisoloneApotheca Inc.ANDACurrent
21695-365PrednisolonePrednisoloneRebel Distributors CorpANDACurrent
50090-0655PrednisolonePrednisoloneA-S Medication SolutionsANDACurrent
50090-0655PrednisolonePrednisoloneA-S Medication SolutionsANDACurrent
50090-0655PrednisolonePrednisoloneA-S Medication SolutionsANDACurrent
50090-0655PrednisolonePrednisoloneA-S Medication SolutionsANDACurrent
50383-042PrednisolonePrednisoloneHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-042PrednisolonePrednisoloneAkornANDACurrent
50383-042PrednisolonePrednisoloneAkornANDACurrent
50383-042PrednisolonePrednisoloneHi-Tech Pharmacal Co., Inc.ANDACurrent
53217-193PrednisolonePrednisoloneAidarex Pharmaceuticals LLCANDACurrent
61919-291PREDNISOLONEPREDNISOLONEDIRECT RXANDACurrent
61919-291PREDNISOLONEPREDNISOLONEDIRECT RXANDACurrent
63187-466PrednisolonePrednisoloneProficient Rx LPANDACurrent
63187-466PrednisolonePrednisoloneProficient Rx LPANDACurrent
63629-1862PrednisolonePrednisoloneBryant Ranch PrepackANDACurrent
67296-1656PrednisolonePrednisoloneRedPharm Drug, Inc.ANDACurrent
67296-1656PrednisolonePrednisoloneRedPharm Drug, Inc.ANDACurrent
68258-8987PrednisolonePrednisoloneDispensing Solutions, Inc.ANDACurrent
68788-9096PrednisolonePrednisolonePreferred Pharmaceuticals, IncANDACurrent
68788-9096PrednisolonePrednisolonePreferred Pharmaceuticals, IncANDACurrent
68788-9096PrednisolonePrednisolonePreferred Pharmaceuticals, IncANDACurrent
70518-2084PrednisolonePrednisoloneREMEDYREPACK INC.ANDACurrent