FDA.reportPublic FDA data

Application 040189

Type
ANDA
Sponsor
JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONEMETHYLPREDNISOLONETABLET;ORAL4MGNoNo
002METHYLPREDNISOLONEMETHYLPREDNISOLONETABLET;ORAL8MGNoNo
003METHYLPREDNISOLONEMETHYLPREDNISOLONETABLET;ORAL16MGNoNo
004METHYLPREDNISOLONEMETHYLPREDNISOLONETABLET;ORAL32MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-080MethylprednisoloneMethylprednisoloneRebel Distributors Corp.ANDACurrent
33261-335MethylprednisoloneMethylprednisoloneAidarex Pharmaceuticals LLCANDACurrent
45865-417MethylprednisoloneMethylprednisoloneMedsource PharmaceuticalsANDACurrent
50090-3094MethylprednisoloneMethylprednisoloneA-S Medication SolutionsANDACurrent
50090-3094MethylprednisoloneMethylprednisoloneA-S Medication SolutionsANDACurrent
50436-0001MethylprednisoloneMethylprednisoloneUnit Dose ServicesANDACurrent
50436-4037MethylprednisoloneMethylprednisoloneUnit Dose ServicesANDACurrent
53002-3120MethylprednisoloneMethylprednisoloneRPK Pharmaceuticals, Inc.ANDACurrent
53002-3120MethylprednisoloneMethylprednisoloneRPK Pharmaceuticals, Inc.ANDACurrent
59746-001MethylprednisoloneMethylprednisoloneJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-002MethylprednisoloneMethylprednisoloneJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-003MethylprednisoloneMethylprednisoloneJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-015MethylprednisoloneMethylprednisoloneJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
61919-149MethylprednisoloneMethylprednisoloneDIRECT RXANDACurrent
61919-149MethylprednisoloneMethylprednisoloneDIRECT RXANDACurrent
63187-160MethylprednisoloneMethylprednisoloneProficient Rx LPANDACurrent
63187-160MethylprednisoloneMethylprednisoloneProficient Rx LPANDACurrent
63629-2433MethylprednisoloneMethylprednisoloneBryant Ranch PrepackANDACurrent
63629-2433MethylprednisoloneMethylprednisoloneBryant Ranch PrepackANDACurrent
63629-3910MethylprednisoloneMethylprednisoloneBryant Ranch PrepackANDACurrent
68001-005MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-005MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-005MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-005MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-557MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-557MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-558MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-558MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-559MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-559MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-560MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68001-560MethylprednisoloneMethylprednisoloneBluePoint LaboratoriesANDACurrent
68071-4028MethylprednisoloneMethylprednisoloneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4028MethylprednisoloneMethylprednisoloneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-4593MethylprednisoloneMethylprednisolonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-4593MethylprednisoloneMethylprednisolonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-4593MethylprednisoloneMethylprednisolonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-4593MethylprednisoloneMethylprednisolonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-4593MethylprednisoloneMethylprednisolonePreferred Pharmaceuticals, Inc.ANDACurrent
69306-004MethylprednisoloneMethylprednisoloneDoc RxANDACurrent
69306-004MethylprednisoloneMethylprednisoloneDoc RxANDACurrent
70518-2982MethylprednisoloneMethylprednisoloneREMEDYREPACK INC.ANDACurrent
70786-0001MethylprednisoloneMethylprednisoloneUnit Dose ServicesANDACurrent
76420-041MethylprednisoloneMethylprednisoloneAsclemed USA, Inc.ANDACurrent
76420-041MethylprednisoloneMethylprednisoloneAsclemed USA, Inc.ANDACurrent