FDA.reportPublic FDA data

Application 209111

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL10MGNoNo
003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-943Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-943Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-943Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-944Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-944Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-944Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-945Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-945Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-945Dextroamphetamine SulfateDextroamphetamine SulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent