FDA.reportPublic FDA data

Application 210059

Type
ANDA
Sponsor
NUVO PHARM

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
11534-188DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-188DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-188DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-188DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-188DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-188DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-189DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-189DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-189DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-189DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-189DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
11534-189DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSUNRISE PHARMACEUTICAL, INC.ANDACurrent
63629-2374DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-2374DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-2375DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-2375DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateBryant Ranch PrepackANDACurrent