FDA.reportPublic FDA data

Application 204330

Type
ANDA
Sponsor
NOVEL LABS INC

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
40032-870Dextroamphetamine Sulfatedextroamphetamine sulfateNovel Laboratories, Inc.ANDACurrent
40032-871Dextroamphetamine Sulfatedextroamphetamine sulfateNovel Laboratories, Inc.ANDACurrent
43386-870Dextroamphetamine Sulfatedextroamphetamine sulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-870Dextroamphetamine Sulfatedextroamphetamine sulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-871Dextroamphetamine Sulfatedextroamphetamine sulfateLupin Pharmaceuticals,Inc.ANDACurrent
43386-871Dextroamphetamine Sulfatedextroamphetamine sulfateLupin Pharmaceuticals,Inc.ANDACurrent