FDA.reportPublic FDA data

Application 211861

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPHETAMINE SULFATEAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
002AMPHETAMINE SULFATEAMPHETAMINE SULFATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-457AMPHETAMINE SULFATEamphetamine sulfateSolco Healthcare US, LLCANDACurrent
43547-457AMPHETAMINE SULFATEamphetamine sulfateSolco Healthcare US, LLCANDACurrent
43547-458AMPHETAMINE SULFATEamphetamine sulfateSolco Healthcare US, LLCANDACurrent
43547-458AMPHETAMINE SULFATEamphetamine sulfateSolco Healthcare US, LLCANDACurrent
63629-1114AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-1114AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-1115AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-1115AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent