FDA.reportPublic FDA data

Application 206588

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-941DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-941DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-941DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-942DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-942DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-942DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent