FDA.reportPublic FDA data

Application 202893

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

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
13107-035DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-035DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-035DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-036DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-036DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-036DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent