FDA.reportPublic FDA data

Application 040361

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0952Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0952Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0952Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0952Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0952Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0952Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0953Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0953Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0953Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0953Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0953Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0953Dextroamphetamine SulfateDextroamphetamine SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38888SUPPL2014-08-06
7637SUPPL2014-04-03
29939ORIG2004-06-02
17776ORIG2004-06-02
22134ORIG2003-07-31