Amphetamine / Dextroamphetamine Oral Tablet

Brand(s)
Adderall
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Barr Laboratories Inc. (2015-08-04)
Oldest Current Product
1996-02-13
License(s)
ANDA
RxNORM
ORAL TABLET\AMPHETAMINE:DEXTROAMPHETAMINE
FDAOB
ORAL\TABLET\AMPHETAMINE ASPARTATE: AMPHETAMINE SULFATE: DEXTROAMPHETAMINE SACCHARATE: DEXTROAMPHETAMINE SULFATE
SPL Active
ORAL\TABLET\AMPHETAMINE ASPARTATE MONOHYDRATE: AMPHETAMINE SULFATE: DEXTROAMPHETAMINE SACCHARATE: DEXTROAMPHETAMINE SULFATE
ORAL\TABLET\AMPHETAMINE ASPARTATE: AMPHETAMINE SULFATE: DEXTROAMPHETAMINE SACCHARATE: DEXTROAMPHETAMINE SULFATE
SPL Moiety
ORAL\TABLET\AMPHETAMINE: DEXTROAMPHETAMINE

product(s) by strength(s)

amphetamine aspartate 1.25 mg / amphetamine sulfate 1.25 mg / dextroamphetamine saccharate 1.25 mg / dextroamphetamine sulfate 1.25 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850084ANDAEon Labs, Inc.2002-09-27AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040439afdedf03-f393-454d-9158-99e36071fa93
2003784541ANDAMylan Pharmaceuticals Inc.2015-11-10AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA20672149289133-6071-406e-8b18-73a6e4db8782
3004068891ANDAMallinckrodt, Inc.2010-02-18AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA04044072ddd1c9-ddbd-4c95-acd9-003189a353a3
4005550971ANDABarr Laboratories Inc.2002-02-11AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422cffbbb15-d776-41ae-a8a6-687f2c07bfa4
5131070068ANDAAurolife Pharma Llc2013-11-27AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA202424a582d57f-d191-4ca5-b105-585b2d8a0e3e
6459630743ANDAActavis Inc.2014-09-02AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040456ffd56d70-d884-43be-a994-6e70a10e823e
7576640641ANDACaraco Pharmaceutical Laboratories, Ltd.2003-09-09AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404809af67219-9b37-45d0-ac52-647cbfacd296
8578440105AdderallANDATeva Select Brands2014-11-13AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422f22635fe-821d-4cde-aa12-419f8b53db81
9647200130ANDACorepharma, Llc2007-05-09AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404444cc84b5d-9b56-4b80-a201-6e4075727d44

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684631ANDAPhysicians Total Care, Inc.2002-06-04AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET004068891ANDA040440d63a086a-32e2-49e2-949e-64e4c922775a
2680840874ANDAAmerican Health Packaging2014-12-04AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET001850084ANDA040439fdeb76f5-e6af-4f8b-b901-731d65a70b18

amphetamine aspartate 1.875 mg / amphetamine sulfate 1.875 mg / dextroamphetamine saccharate 1.875 mg / dextroamphetamine sulfate 1.875 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784542ANDAMylan Pharmaceuticals Inc.2015-11-10AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA20672149289133-6071-406e-8b18-73a6e4db8782
2004068884ANDAMallinckrodt, Inc.2010-02-18AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA04044072ddd1c9-ddbd-4c95-acd9-003189a353a3
3005550775ANDABarr Laboratories Inc.2003-03-19AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422cffbbb15-d776-41ae-a8a6-687f2c07bfa4
4131070069ANDAAurolife Pharma Llc2013-11-27AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA202424a582d57f-d191-4ca5-b105-585b2d8a0e3e
5576640642ANDACaraco Pharmaceutical Laboratories, Ltd.2003-09-09AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404809af67219-9b37-45d0-ac52-647cbfacd296
6578440117AdderallANDATeva Select Brands2015-03-03AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422f22635fe-821d-4cde-aa12-419f8b53db81
7647200131ANDACorepharma, Llc2014-11-07AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404444cc84b5d-9b56-4b80-a201-6e4075727d44

amphetamine aspartate 2.5 mg / amphetamine sulfate 2.5 mg / dextroamphetamine saccharate 2.5 mg / dextroamphetamine sulfate 2.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850111ANDAEon Labs, Inc.2002-06-14AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040439afdedf03-f393-454d-9158-99e36071fa93
2003784543ANDAMylan Pharmaceuticals Inc.2015-11-10AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA20672149289133-6071-406e-8b18-73a6e4db8782
3004068892ANDAMallinckrodt, Inc.2010-02-18AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA04044072ddd1c9-ddbd-4c95-acd9-003189a353a3
4005550972ANDABarr Laboratories Inc.2002-02-11AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422cffbbb15-d776-41ae-a8a6-687f2c07bfa4
5131070070ANDAAurolife Pharma Llc2013-11-27AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA202424a582d57f-d191-4ca5-b105-585b2d8a0e3e
6459630745ANDAActavis Inc.2014-03-31AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040456ffd56d70-d884-43be-a994-6e70a10e823e
7576640643ANDACaraco Pharmaceutical Laboratories, Ltd.2003-09-09AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404809af67219-9b37-45d0-ac52-647cbfacd296
8578440110AdderallANDATeva Select Brands2014-02-03AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422f22635fe-821d-4cde-aa12-419f8b53db81
9647200132ANDACorepharma, Llc2007-05-09AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404444cc84b5d-9b56-4b80-a201-6e4075727d44

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684728ANDAPhysicians Total Care, Inc.2003-01-17AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET004068892ANDA040440d63a086a-32e2-49e2-949e-64e4c922775a
2636293730ANDABryant Ranch Prepack2002-02-11AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET005550972ANDA0404226670decb-e6bb-462e-9cec-cd70fde20b58
3636293768AdderallANDABryant Ranch Prepack1996-02-13AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET005550764ANDA04042249b7d111-7045-4116-8988-ba93c7d63491
4680840936ANDAAmerican Health Packaging2015-03-15AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET001850111ANDA040439fdeb76f5-e6af-4f8b-b901-731d65a70b18

amphetamine aspartate 3.125 mg / amphetamine sulfate 3.125 mg / dextroamphetamine saccharate 3.125 mg / dextroamphetamine sulfate 3.125 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784544ANDAMylan Pharmaceuticals Inc.2015-11-10AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA20672149289133-6071-406e-8b18-73a6e4db8782
2004068886ANDAMallinckrodt, Inc.2010-02-18AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA04044072ddd1c9-ddbd-4c95-acd9-003189a353a3
3005550776ANDABarr Laboratories Inc.2003-03-19AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422cffbbb15-d776-41ae-a8a6-687f2c07bfa4
4131070071ANDAAurolife Pharma Llc2013-11-27AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA202424a582d57f-d191-4ca5-b105-585b2d8a0e3e
5576640644ANDACaraco Pharmaceutical Laboratories, Ltd.2003-09-09AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404809af67219-9b37-45d0-ac52-647cbfacd296
6578440112AdderallANDATeva Select Brands2014-06-18AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422f22635fe-821d-4cde-aa12-419f8b53db81
7647200133ANDACorepharma, Llc2014-11-07AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404444cc84b5d-9b56-4b80-a201-6e4075727d44

amphetamine aspartate 3.75 mg / amphetamine sulfate 3.75 mg / dextroamphetamine saccharate 3.75 mg / dextroamphetamine sulfate 3.75 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784545ANDAMylan Pharmaceuticals Inc.2015-11-10AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA20672149289133-6071-406e-8b18-73a6e4db8782
2004068885ANDAMallinckrodt, Inc.2010-02-18AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA04044072ddd1c9-ddbd-4c95-acd9-003189a353a3
3005550777ANDABarr Laboratories Inc.2003-03-19AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422cffbbb15-d776-41ae-a8a6-687f2c07bfa4
4131070072ANDAAurolife Pharma Llc2013-11-27AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA202424a582d57f-d191-4ca5-b105-585b2d8a0e3e
5576640645ANDACaraco Pharmaceutical Laboratories, Ltd.2003-09-09AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404809af67219-9b37-45d0-ac52-647cbfacd296
6578440115AdderallANDATeva Select Brands2014-06-30AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422f22635fe-821d-4cde-aa12-419f8b53db81
7647200134ANDACorepharma, Llc2014-11-07AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404444cc84b5d-9b56-4b80-a201-6e4075727d44

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685387ANDAPhysicians Total Care, Inc.2005-08-11AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET004068886ANDA040440d63a086a-32e2-49e2-949e-64e4c922775a
2606870133ANDAAmerican Health Packaging2015-03-31AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET005550777ANDA04042239ebdc79-5403-4c2e-b366-12f8491e8bca

amphetamine aspartate 5 mg / amphetamine sulfate 5 mg / dextroamphetamine saccharate 5 mg / dextroamphetamine sulfate 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850401ANDAEon Labs, Inc.2002-06-14AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040439afdedf03-f393-454d-9158-99e36071fa93
2003784546ANDAMylan Pharmaceuticals Inc.2015-11-10AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA20672149289133-6071-406e-8b18-73a6e4db8782
3004068893ANDAMallinckrodt, Inc.2010-02-18AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA04044072ddd1c9-ddbd-4c95-acd9-003189a353a3
4005550973ANDABarr Laboratories Inc.2002-02-11AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422cffbbb15-d776-41ae-a8a6-687f2c07bfa4
5131070073ANDAAurolife Pharma Llc2013-11-27AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA202424a582d57f-d191-4ca5-b105-585b2d8a0e3e
6459630748ANDAActavis Inc.2014-03-31AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040456ffd56d70-d884-43be-a994-6e70a10e823e
7576640646ANDACaraco Pharmaceutical Laboratories, Ltd.2003-09-09AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404809af67219-9b37-45d0-ac52-647cbfacd296
8578440120AdderallANDATeva Select Brands2014-02-11AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422f22635fe-821d-4cde-aa12-419f8b53db81
9647200135ANDACorepharma, Llc2007-05-09AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404444cc84b5d-9b56-4b80-a201-6e4075727d44

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685103ANDAPhysicians Total Care, Inc.2004-07-07AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET004068893ANDA040440d63a086a-32e2-49e2-949e-64e4c922775a
2636293731ANDABryant Ranch Prepack2009-12-18AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET005550973ANDA0404221714de28-482e-463f-e91f-eeaaaa83d17f
3636293769AdderallANDABryant Ranch Prepack1996-02-13AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET005550767ANDA040422b6c8d902-4d43-46b0-b96c-00d8bed1b3dd
4680840943ANDAAmerican Health Packaging2015-03-15AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET001850401ANDA040439fdeb76f5-e6af-4f8b-b901-731d65a70b18

amphetamine aspartate 7.5 mg / amphetamine sulfate 7.5 mg / dextroamphetamine saccharate 7.5 mg / dextroamphetamine sulfate 7.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850404ANDAEon Labs, Inc.2002-06-14AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040439afdedf03-f393-454d-9158-99e36071fa93
2003784547ANDAMylan Pharmaceuticals Inc.2015-11-10AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA20672149289133-6071-406e-8b18-73a6e4db8782
3004068894ANDAMallinckrodt, Inc.2010-02-18AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA04044072ddd1c9-ddbd-4c95-acd9-003189a353a3
4005550974ANDABarr Laboratories Inc.2002-02-11AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422cffbbb15-d776-41ae-a8a6-687f2c07bfa4
5131070074ANDAAurolife Pharma Llc2013-11-27AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA202424a582d57f-d191-4ca5-b105-585b2d8a0e3e
6459630749ANDAActavis Inc.2014-03-31AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040456ffd56d70-d884-43be-a994-6e70a10e823e
7576640647ANDACaraco Pharmaceutical Laboratories, Ltd.2003-09-09AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404809af67219-9b37-45d0-ac52-647cbfacd296
8578440130AdderallANDATeva Select Brands2014-02-06AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA040422f22635fe-821d-4cde-aa12-419f8b53db81
9647200136ANDACorepharma, Llc2007-05-09AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLETANDA0404444cc84b5d-9b56-4b80-a201-6e4075727d44

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900901ANDAStat Rx Usa Llc2009-12-18AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET005550974ANDA040422f55aba1f-9404-4a49-8e3b-7a66ce538c60
2548684863ANDAPhysicians Total Care, Inc.2003-07-25AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET004068894ANDA040440d63a086a-32e2-49e2-949e-64e4c922775a
3606870154ANDAAmerican Health Packaging2015-03-15AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATEORALTABLET001850404ANDA040439f0618c47-ca45-4652-9002-4465f6bc7fe4

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA040422DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEBARR LABORATORIES INC2002-02-11ANDA040422_001, ANDA040422_002, ANDA040422_003, ANDA040422_004, ANDA040422_005, ANDA040422_006, ANDA040422_007
2ANDA040439DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATESANDOZ INC2002-06-14ANDA040439_001, ANDA040439_002, ANDA040439_003, ANDA040439_004
3ANDA040440DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEMALLINCKRODT INC2003-10-07ANDA040440_001, ANDA040440_002, ANDA040440_003, ANDA040440_004, ANDA040440_005, ANDA040440_006, ANDA040440_007
4ANDA040444DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATECOREPHARMA LLC2002-06-19ANDA040444_001, ANDA040444_002, ANDA040444_003, ANDA040444_004, ANDA040444_005, ANDA040444_006, ANDA040444_007
5ANDA040456DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEACTAVIS ELIZABETH LLC2003-05-06ANDA040456_001, ANDA040456_002, ANDA040456_003, ANDA040456_004
6ANDA040472DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATETrueTEVA PHARMACEUTICALS USA2003-09-30ANDA040472_001, ANDA040472_002, ANDA040472_003, ANDA040472_004
7ANDA040480DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEMUTUAL PHARMACEUTICAL CO INC2003-09-09ANDA040480_001, ANDA040480_002, ANDA040480_003, ANDA040480_004, ANDA040480_005, ANDA040480_006, ANDA040480_007
8ANDA202424DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAUROLIFE PHARMA LLC2013-11-27ANDA202424_001, ANDA202424_002, ANDA202424_003, ANDA202424_004, ANDA202424_005, ANDA202424_006, ANDA202424_007
9ANDA206721DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEMYLAN PHARMACEUTICALS INC2015-11-10ANDA206721_001, ANDA206721_002, ANDA206721_003, ANDA206721_004, ANDA206721_005, ANDA206721_006, ANDA206721_007
10NDA011522ADDERALL 10TrueTEVA WOMENS HEALTH INC1996-02-13p6384020NDA011522_007, NDA011522_008, NDA011522_009, NDA011522_010, NDA011522_011, NDA011522_012, NDA011522_013

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040422_001RXAMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG)ORALTABLETFalseAB2002-02-11DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
2ANDA040422_002RXDEXTROAMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG)ORALTABLETFalseAB2002-02-11DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
3ANDA040422_003RXAMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAB2002-02-11DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
4ANDA040422_004RXAMPHETAMINE ASPARTATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG)ORALTABLETTrueAB2002-02-11DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
5ANDA040422_005RXAMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG)ORALTABLETFalseAB2003-03-19DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
6ANDA040422_006RXDEXTROAMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG)ORALTABLETFalseAB2003-03-19DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
7ANDA040422_007RXAMPHETAMINE ASPARTATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG)ORALTABLETFalseAB2003-03-19DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
8ANDA040439_001RXDEXTROAMPHETAMINE SACCHARATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG)ORALTABLETFalseAB2002-06-14DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
9ANDA040439_002RXAMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAB2002-06-14DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
10ANDA040439_003RXAMPHETAMINE ASPARTATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG)ORALTABLETFalseAB2002-06-14DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
11ANDA040439_004RXAMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG)ORALTABLETFalseAB2002-09-27DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
12ANDA040440_001RXAMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE SULFATE (1.25MG)ORALTABLETFalseAB2003-10-07DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
13ANDA040440_002RXAMPHETAMINE ASPARTATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG)ORALTABLETFalseAB2003-10-07DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
14ANDA040440_003RXDEXTROAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG)ORALTABLETFalseAB2003-10-07DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
15ANDA040440_004RXDEXTROAMPHETAMINE SACCHARATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG)ORALTABLETFalseAB2003-10-07DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
16ANDA040440_005RXAMPHETAMINE ASPARTATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG)ORALTABLETFalseAB2003-10-07DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
17ANDA040440_006RXAMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG)ORALTABLETFalseAB2003-10-07DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
18ANDA040440_007RXAMPHETAMINE ASPARTATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), AMPHETAMINE SULFATE (7.5MG)ORALTABLETFalseAB2003-10-07DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
19ANDA040444_001RXDEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG)ORALTABLETFalseAB2002-06-19DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
20ANDA040444_002RXDEXTROAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG)ORALTABLETFalseAB2002-06-19DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
21ANDA040444_003RXAMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAB2002-06-19DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
22ANDA040444_004RXAMPHETAMINE ASPARTATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG)ORALTABLETFalseAB2002-06-19DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
23ANDA040444_005RXDEXTROAMPHETAMINE SULFATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG)ORALTABLETFalseAB2014-11-03DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
24ANDA040444_006RXAMPHETAMINE ASPARTATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG)ORALTABLETFalseAB2014-11-03DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
25ANDA040444_007RXDEXTROAMPHETAMINE SACCHARATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), AMPHETAMINE ASPARTATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG)ORALTABLETFalseAB2014-11-03DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
26ANDA040456_001RXDEXTROAMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), AMPHETAMINE SULFATE (1.25MG)ORALTABLETFalseAB2003-05-06DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
27ANDA040456_002RXAMPHETAMINE ASPARTATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG)ORALTABLETFalseAB2003-05-06DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
28ANDA040456_003RXAMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG)ORALTABLETFalseAB2003-05-06DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
29ANDA040456_004RXDEXTROAMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG)ORALTABLETFalseAB2003-05-06DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
30ANDA040472_001discontinuedAMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG)ORALTABLETFalse2003-09-30DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
31ANDA040472_002discontinuedDEXTROAMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG)ORALTABLETFalse2003-09-30DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
32ANDA040472_003discontinuedDEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE ASPARTATE (5MG)ORALTABLETFalse2003-09-30DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
33ANDA040472_004discontinuedDEXTROAMPHETAMINE SACCHARATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG), AMPHETAMINE SULFATE (7.5MG)ORALTABLETFalse2003-09-30DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
34ANDA040480_001RXDEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE SULFATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG)ORALTABLETFalseAB2003-09-09DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
35ANDA040480_002RXDEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG)ORALTABLETFalseAB2003-09-09DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
36ANDA040480_003RXAMPHETAMINE ASPARTATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG)ORALTABLETFalseAB2003-09-09DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
37ANDA040480_004RXAMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG)ORALTABLETFalseAB2003-09-09DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
38ANDA040480_005RXDEXTROAMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), AMPHETAMINE ASPARTATE (3.75MG)ORALTABLETFalseAB2003-09-09DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
39ANDA040480_006RXAMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAB2003-09-09DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
40ANDA040480_007RXAMPHETAMINE ASPARTATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG)ORALTABLETFalseAB2003-09-09DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
41ANDA202424_001RXDEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE SULFATE (1.25MG)ORALTABLETFalseAB2013-11-27DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
42ANDA202424_002RXDEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG)ORALTABLETFalseAB2013-11-27DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
43ANDA202424_003RXAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG)ORALTABLETFalseAB2013-11-27DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
44ANDA202424_004RXDEXTROAMPHETAMINE SACCHARATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG)ORALTABLETFalseAB2013-11-27DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
45ANDA202424_005RXAMPHETAMINE SULFATE (3.75MG), AMPHETAMINE ASPARTATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG)ORALTABLETFalseAB2013-11-27DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
46ANDA202424_006RXDEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG)ORALTABLETFalseAB2013-11-27DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
47ANDA202424_007RXAMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG)ORALTABLETFalseAB2013-11-27DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
48ANDA206721_001RXAMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG)ORALTABLETFalseAB2015-11-10DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
49ANDA206721_002RXDEXTROAMPHETAMINE SULFATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG)ORALTABLETFalseAB2015-11-10DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
50ANDA206721_003RXDEXTROAMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG)ORALTABLETFalseAB2015-11-10DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
51ANDA206721_004RXDEXTROAMPHETAMINE SULFATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG)ORALTABLETFalseAB2015-11-10DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
52ANDA206721_005RXAMPHETAMINE ASPARTATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG)ORALTABLETFalseAB2015-11-10DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
53ANDA206721_006RXDEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAB2015-11-10DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
54ANDA206721_007RXDEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), AMPHETAMINE SULFATE (7.5MG)ORALTABLETFalseAB2015-11-10DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
55NDA011522_007discontinuedDEXTROAMPHETAMINE SACCHARATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), AMPHETAMINE SULFATE (2.5MG)ORALTABLETFalse1996-02-13ADDERALL 10
56NDA011522_008discontinuedDEXTROAMPHETAMINE SACCHARATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), AMPHETAMINE SULFATE (5MG)ORALTABLETFalse1996-02-13ADDERALL 10
57NDA011522_009discontinuedAMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG)ORALTABLETFalse1997-05-12ADDERALL 10
58NDA011522_010discontinuedDEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG)ORALTABLETFalse1997-05-12ADDERALL 10
59NDA011522_011discontinuedAMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG)ORALTABLETFalse2000-08-31ADDERALL 10
60NDA011522_012discontinuedAMPHETAMINE ASPARTATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG)ORALTABLETFalse2000-08-31ADDERALL 10
61NDA011522_013discontinuedDEXTROAMPHETAMINE SACCHARATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG), AMPHETAMINE ASPARTATE (3.75MG), AMPHETAMINE SULFATE (3.75MG)ORALTABLETFalse2000-08-31ADDERALL 10

patent(s)

#idexpiration dateapplication(s)
1p6384020 (view patent)2020-07-06NDA011522

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11714de28-482e-463f-e91f-eeaaaa83d17f (view SPL)DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATEprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-124636293731
239ebdc79-5403-4c2e-b366-12f8491e8bca (view SPL)DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-271606870133
349289133-6071-406e-8b18-73a6e4db8782 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-082003784541, 003784542, 003784543, 003784544, 003784545, 003784546, 003784547
449b7d111-7045-4116-8988-ba93c7d63491 (view SPL)Adderall CII (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets)prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231000636293768
54cc84b5d-9b56-4b80-a201-6e4075727d44 (view SPL)DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS (Mixed Salts of a Single-Entity Amphetamine Product)5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg CII Rx onlyprescriptionHuman PrescriptionCorepharma, Llc2015-06-1739647200130, 647200131, 647200132, 647200133, 647200134, 647200135, 647200136
66670decb-e6bb-462e-9cec-cd70fde20b58 (view SPL)DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CIIprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231000636293730
772ddd1c9-ddbd-4c95-acd9-003189a353a3 (view SPL)Dextroamphetamine SaccharateAmphetamine AspartateDextroamphetamine SulfateAmphetamine Sulfate Tablets(Mixed Salts of a Single Entity Amphetamine Product) (5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg) CII Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.2015-04-3014004068884, 004068885, 004068886, 004068891, 004068892, 004068893, 004068894
89af67219-9b37-45d0-ac52-647cbfacd296 (view SPL)Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.2015-05-064576640641, 576640642, 576640643, 576640644, 576640645, 576640646, 576640647
9a582d57f-d191-4ca5-b105-585b2d8a0e3e (view SPL)Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx OnlyprescriptionHuman PrescriptionAurolife Pharma LlcLABEL, MANUFACTURE, PACK, RELABEL, REPACK2015-02-204131070068, 131070069, 131070070, 131070071, 131070072, 131070073, 131070074
10afdedf03-f393-454d-9158-99e36071fa93 (view SPL)Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets CII (Mixed Salts of a Single Entity Amphetamine Product)prescriptionHuman PrescriptionEon Labs, Inc.2015-02-1714001850084, 001850111, 001850401, 001850404
11b6c8d902-4d43-46b0-b96c-00d8bed1b3dd (view SPL)Adderall CII (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets)prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231000636293769
12cffbbb15-d776-41ae-a8a6-687f2c07bfa4 (view SPL)DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS (MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT) CIIprescriptionHuman PrescriptionBarr Laboratories Inc.2015-08-0414005550775, 005550776, 005550777, 005550971, 005550972, 005550973, 005550974
13d63a086a-32e2-49e2-949e-64e4c922775a (view SPL)CII Rx OnlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-07-096548684631, 548684728, 548684863, 548685103, 548685387
14f0618c47-ca45-4652-9002-4465f6bc7fe4 (view SPL)Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-261606870154
15f22635fe-821d-4cde-aa12-419f8b53db81 (view SPL)Adderall CII (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product))prescriptionHuman PrescriptionTeva Select Brands2015-08-045578440105, 578440110, 578440112, 578440115, 578440117, 578440120, 578440130
16f55aba1f-9404-4a49-8e3b-7a66ce538c60 (view SPL)DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CIIprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-06-251165900901
17fdeb76f5-e6af-4f8b-b901-731d65a70b18 (view SPL)Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TabletsCIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-252680840874, 680840936, 680840943
18ffd56d70-d884-43be-a994-6e70a10e823e (view SPL)40-9239 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CII (Mixed Salts of a Single-Entity Amphetamine Product) Revised February 2015 Rx OnlyprescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-02-135459630743, 459630745, 459630748, 459630749

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII