FDA.reportPublic FDA data

Application 216537

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET;ORAL10MG;100MGNoNo
002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET;ORAL25MG;100MGNoNo
003CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET;ORAL25MG;250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59651-456Carbidopa and LevodopaCarbidopa and LevodopaAurobindo Pharma LimitedANDACurrent
59651-456Carbidopa and LevodopaCarbidopa and LevodopaAurobindo Pharma LimitedANDACurrent
59651-457Carbidopa and LevodopaCarbidopa and LevodopaAurobindo Pharma LimitedANDACurrent
59651-457Carbidopa and LevodopaCarbidopa and LevodopaAurobindo Pharma LimitedANDACurrent
59651-458Carbidopa and LevodopaCarbidopa and LevodopaAurobindo Pharma LimitedANDACurrent
59651-458Carbidopa and LevodopaCarbidopa and LevodopaAurobindo Pharma LimitedANDACurrent