FDA.reportPublic FDA data

Application 213386

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL10MGNoNo
002PREDNISONEPREDNISONETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8440prednisoneprednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8441prednisoneprednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
50090-6122prednisoneprednisoneA-S Medication SolutionsANDACurrent
50090-6123prednisoneprednisoneA-S Medication SolutionsANDACurrent
50090-6259prednisoneprednisoneA-S Medication SolutionsANDACurrent
60219-1707prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1707prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1707prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1707prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1708prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1708prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1708prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1708prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
68788-8212prednisoneprednisonePreferred Pharmaceuticals Inc.ANDACurrent
70518-3540prednisoneprednisoneREMEDYREPACK INC.ANDACurrent