FDA.reportPublic FDA data

Application 210043

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION40MG/MLNoNo
002METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION80MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5894Methylprednisolone acetateMethylprednisolone acetateA-S Medication SolutionsANDACurrent
50090-6024Methylprednisolone acetateMethylprednisolone acetateA-S Medication SolutionsANDACurrent
60219-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals NY LLCANDACurrent
60219-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals NY LLCANDACurrent
70121-1552Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1552Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Biosciences LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1573Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Pharmaceuticals LLCANDACurrent
70121-1574Methylprednisolone acetateMethylprednisolone acetateAmneal Biosciences LLCANDACurrent
70518-2915Methylprednisolone acetateMethylprednisolone acetateREMEDYREPACK INC.ANDACurrent
70518-3071Methylprednisolone acetateMethylprednisolone acetateREMEDYREPACK INC.ANDACurrent