FDA.reportPublic FDA data

Application 214091

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

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
50228-460Carbidopa and LevodopaCarbidopa and LevodopaScieGen Pharmaceuticals IncANDACurrent
50228-461Carbidopa and LevodopaCarbidopa and LevodopaScieGen Pharmaceuticals IncANDACurrent