FDA.reportPublic FDA data

Application 206095

Type
ANDA
Sponsor
TRIS PHARMA 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
27808-089Dextroamphetamine SulfateDextroamphetamine SulfateTris Pharma IncANDACurrent
27808-090Dextroamphetamine SulfateDextroamphetamine SulfateTris Pharma IncANDACurrent