FDA.reportPublic FDA data

Application 210341

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

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
46708-332Carbidopa and LevodopaCarbidopa and LevodopaAlembic Pharmaceuticals LimitedANDACurrent
46708-333Carbidopa and LevodopaCarbidopa and LevodopaAlembic Pharmaceuticals LimitedANDACurrent
62332-332Carbidopa and LevodopaCarbidopa and LevodopaAlembic Pharmaceuticals Inc.ANDACurrent
62332-333Carbidopa and LevodopaCarbidopa and LevodopaAlembic Pharmaceuticals Inc.ANDACurrent