FDA.reportPublic FDA data

Application 213385

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL1MGNoNo
002PREDNISONEPREDNISONETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8439prednisoneprednisoneNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
51655-988prednisoneprednisoneNorthwind PharmaceuticalsANDACurrent
60219-1705prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1705prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1706prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-1706prednisoneprednisoneAmneal Pharmaceuticals NY LLCANDACurrent
68788-8267prednisoneprednisonePreferred Pharmaceuticals Inc.ANDACurrent