FDA.reportPublic FDA data

Application 202323

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET, EXTENDED RELEASE;ORAL25MG;100MGNoNo
002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET, EXTENDED RELEASE;ORAL50MG;200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-078CARBIDOPA AND LEVODOPACarbidopa and LevodopaAccord Healthcare, Inc.ANDACurrent
16729-078CARBIDOPA AND LEVODOPACarbidopa and LevodopaAccord Healthcare, Inc.ANDACurrent
16729-078CARBIDOPA AND LEVODOPACarbidopa and LevodopaAccord Healthcare, Inc.ANDACurrent
16729-079CARBIDOPA AND LEVODOPACarbidopa and LevodopaAccord Healthcare, Inc.ANDACurrent
16729-079CARBIDOPA AND LEVODOPACarbidopa and LevodopaAccord Healthcare, Inc.ANDACurrent
16729-079CARBIDOPA AND LEVODOPACarbidopa and LevodopaAccord Healthcare, Inc.ANDACurrent
68001-171CARBIDOPA AND LEVODOPACarbidopa and LevodopaBluePoint LaboratoriesANDACurrent
68001-171CARBIDOPA AND LEVODOPACarbidopa and LevodopaBluePoint LaboratoriesANDACurrent
68001-171CARBIDOPA AND LEVODOPACarbidopa and LevodopaBluePoint LaboratoriesANDACurrent
68001-172CARBIDOPA AND LEVODOPACarbidopa and LevodopaBluePoint LaboratoriesANDACurrent
68001-172CARBIDOPA AND LEVODOPACarbidopa and LevodopaBluePoint LaboratoriesANDACurrent
68001-172CARBIDOPA AND LEVODOPACarbidopa and LevodopaBluePoint LaboratoriesANDACurrent