FDA.reportPublic FDA data

Application 040436

Type
ANDA
Sponsor
SPECGX 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
0406-8958DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8958DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8958DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8958DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8958DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8959DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8959DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8959DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8959DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8959DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateSpecGx LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65841ORIG2021-01-07