FDA.reportPublic FDA data

Application 210226

Type
ANDA
Sponsor
LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIMETHYL FUMARATEDIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORAL120MGNoNo
002DIMETHYL FUMARATEDIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORAL240MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-776DIMETHYL FUMARATEDIMETHYL FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
68180-776DIMETHYL FUMARATEDIMETHYL FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
68180-777DIMETHYL FUMARATEDIMETHYL FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
68180-777DIMETHYL FUMARATEDIMETHYL FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
68180-778DIMETHYL FUMARATEDIMETHYL FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
68180-778DIMETHYL FUMARATEDIMETHYL FUMARATELupin Pharmaceuticals, Inc.ANDACurrent