FDA.reportPublic FDA data

Application 021303

Type
NDA
Sponsor
SHIRE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADDERALL XR 10AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL2.5MG;2.5MG;2.5MG;2.5MGYesNo
002ADDERALL XR 20AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL5MG;5MG;5MG;5MGYesNo
003ADDERALL XR 30AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL7.5MG;7.5MG;7.5MG;7.5MGYesYes
004ADDERALL XR 25AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL6.25MG;6.25MG;6.25MG;6.25MGYesNo
005ADDERALL XR 5AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL1.25MG;1.25MG;1.25MG;1.25MGYesNo
006ADDERALL XR 15AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL3.75MG;3.75MG;3.75MG;3.75MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1328Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateGlobal Pharmaceuticals, Division of Impax Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0115-1329Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateGlobal Pharmaceuticals, Division of Impax Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0115-1330Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateGlobal Pharmaceuticals, Division of Impax Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0115-1331Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateGlobal Pharmaceuticals, Division of Impax Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0115-1332Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateGlobal Pharmaceuticals, Division of Impax Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0115-1333Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateGlobal Pharmaceuticals, Division of Impax Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0787Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0787Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0788Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0788Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0789Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0789Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0790Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0790Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0791Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0791Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0792Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0555-0792Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateBarr Laboratories Inc.NDA AUTHORIZED GENERICCurrent
0781-2329Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2329Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2329Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHSandoz Inc.NDA AUTHORIZED Current
0781-2329Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2329Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2335Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2335Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2335Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHSandoz Inc.NDA AUTHORIZED Current
0781-2335Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2335Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2343Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2343Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2343Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHSandoz Inc.NDA AUTHORIZED Current
0781-2343Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2343Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2352Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2352Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2352Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHSandoz Inc.NDA AUTHORIZED Current
0781-2352Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2352Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2368Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2368Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2368Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHSandoz Inc.NDA AUTHORIZED Current
0781-2368Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2368Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2371Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2371Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2371Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHSandoz Inc.NDA AUTHORIZED Current
0781-2371Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
0781-2371Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz IncNDA AUTHORIZED GENERICCurrent
43975-331Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-331Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-332Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-332Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-333Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-333Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-334Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-334Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-335Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-335Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-336Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
43975-336Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfatedextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateAmerigen Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
54092-381AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-381AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateShire US Manufacturing Inc.NDACurrent
54092-381AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-381AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-381AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateShire US Manufacturing Inc.NDACurrent
54092-381AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-383AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-383AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateShire US Manufacturing Inc.NDACurrent
54092-383AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-383AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-383AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateShire US Manufacturing Inc.NDACurrent
54092-383AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-385AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-385AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateShire US Manufacturing Inc.NDACurrent
54092-385AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-385AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-385AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateShire US Manufacturing Inc.NDACurrent
54092-385AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-387AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-387AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateShire US Manufacturing Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85755SUPPL 2026-04-27
85802SUPPL 2026-04-24
85744SUPPL 2026-04-24
83507SUPPL 2025-09-25
83439SUPPL 2025-09-25
75775SUPPL 2023-10-16
75738SUPPL 2023-10-16
70345SUPPL2022-03-01
70344SUPPL2022-03-01
70299SUPPL2022-02-28
59269SUPPL2019-07-08
59268SUPPL2019-07-08
54931SUPPL2018-07-20
54907SUPPL2018-07-17
48426SUPPL2017-05-17
48425SUPPL2017-05-17
46846SUPPL2017-01-17
46769SUPPL2017-01-09
36620SUPPL2015-04-21
27429SUPPL2015-04-21
15147SUPPL2014-07-28
4974SUPPL2014-07-25
27428SUPPL2013-12-05
36619SUPPL2013-12-04
15146SUPPL2013-06-18
4973SUPPL2013-06-18
36618SUPPL2013-03-12
27427SUPPL2013-03-11
27426SUPPL2012-02-10
36617SUPPL2012-02-09
27425SUPPL2010-11-18
4972SUPPL2010-11-18
36616SUPPL2010-11-17
15145SUPPL2010-11-17
27424SUPPL2008-11-13
21583SUPPL2007-06-22
15144SUPPL2007-05-29
4971SUPPL2007-05-29
27423SUPPL2006-07-27
15143SUPPL2006-07-27
27422SUPPL2006-06-20
15142SUPPL2006-06-20
27421SUPPL2005-07-26
15141SUPPL2005-07-26
23643ORIG2005-04-15
15140SUPPL2005-02-07
27420SUPPL2004-08-12
21582ORIG2004-05-25
15139SUPPL2002-05-22
4970SUPPL2002-05-22
36615ORIG2001-10-11
4969ORIG2001-10-11
52049SUPPL1900-01-01
52048SUPPL1900-01-01
52047SUPPL1900-01-01
52046SUPPL1900-01-01
52045SUPPL1900-01-01
52044SUPPL1900-01-01