FDA.reportPublic FDA data

Application 213583

Type
ANDA
Sponsor
SPECGX LLC

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
0406-1219Amphetamine SulfateAmphetamine SulfateSpecGx LLCANDACurrent
0406-1219Amphetamine SulfateAmphetamine SulfateSpecGx LLCANDACurrent
0406-1220Amphetamine SulfateAmphetamine SulfateSpecGx LLCANDACurrent
0406-1220Amphetamine SulfateAmphetamine SulfateSpecGx LLCANDACurrent