FDA.reportPublic FDA data

Application 203548

Type
ANDA
Sponsor
AVANTHI 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
10702-065Dextroamphetamine SulfateDextroamphetamine SulfateKVK-Tech, Inc.ANDACurrent
10702-065Dextroamphetamine SulfateDextroamphetamine SulfateKVK-Tech, Inc.ANDACurrent
10702-065Dextroamphetamine SulfateDextroamphetamine SulfateKVK-Tech, Inc.ANDACurrent
10702-066Dextroamphetamine SulfateDextroamphetamine SulfateKVK-Tech, Inc.ANDACurrent
10702-066Dextroamphetamine SulfateDextroamphetamine SulfateKVK-Tech, Inc.ANDACurrent
10702-066Dextroamphetamine SulfateDextroamphetamine SulfateKVK-Tech, Inc.ANDACurrent