FDA.reportPublic FDA data

Application 212901

Type
ANDA
Sponsor
HAVIX

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
0527-2524AMPHETAMINE SULFATEamphetamine sulfateLannett Company, Inc.ANDACurrent
0527-2524AMPHETAMINE SULFATEamphetamine sulfateLannett Company, Inc.ANDACurrent
0527-2524AMPHETAMINE SULFATEamphetamine sulfateLannett Company, Inc.ANDACurrent
0527-2524AMPHETAMINE SULFATEamphetamine sulfateLannett Company, Inc.ANDACurrent
0527-2525AMPHETAMINE SULFATEamphetamine sulfateLannett Company, Inc.ANDACurrent
0527-2525AMPHETAMINE SULFATEamphetamine sulfateLannett Company, Inc.ANDACurrent
0527-2525AMPHETAMINE SULFATEamphetamine sulfateLannett Company, Inc.ANDACurrent
0527-2525AMPHETAMINE SULFATEamphetamine sulfateLannett Company, Inc.ANDACurrent
63629-2078AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-2078AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-2078AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-2079AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-2079AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
63629-2079AMPHETAMINE SULFATEamphetamine sulfateBryant Ranch PrepackANDACurrent
71337-024AMPHETAMINE SULFATEAMPHETAMINE SULFATEHavix Group Inc d-b-a Aavis PharmaceuticalsANDACurrent
71337-024AMPHETAMINE SULFATEAMPHETAMINE SULFATEHavix Group Inc d-b-a Aavis PharmaceuticalsANDACurrent
71337-025AMPHETAMINE SULFATEAMPHETAMINE SULFATEHavix Group Inc d-b-a Aavis PharmaceuticalsANDACurrent
71337-025AMPHETAMINE SULFATEAMPHETAMINE SULFATEHavix Group Inc d-b-a Aavis PharmaceuticalsANDACurrent