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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001850084 | ANDA | Eon Labs, Inc. | 2002-09-27 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040439 | afdedf03-f393-454d-9158-99e36071fa93 | |
| 2 | 003784541 | ANDA | Mylan Pharmaceuticals Inc. | 2015-11-10 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA206721 | 49289133-6071-406e-8b18-73a6e4db8782 | |
| 3 | 004068891 | ANDA | Mallinckrodt, Inc. | 2010-02-18 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040440 | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | |
| 4 | 005550971 | ANDA | Barr Laboratories Inc. | 2002-02-11 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 | |
| 5 | 131070068 | ANDA | Aurolife Pharma Llc | 2013-11-27 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA202424 | a582d57f-d191-4ca5-b105-585b2d8a0e3e | |
| 6 | 459630743 | ANDA | Actavis Inc. | 2014-09-02 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040456 | ffd56d70-d884-43be-a994-6e70a10e823e | |
| 7 | 576640641 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2003-09-09 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040480 | 9af67219-9b37-45d0-ac52-647cbfacd296 | |
| 8 | 578440105 | Adderall | ANDA | Teva Select Brands | 2014-11-13 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | f22635fe-821d-4cde-aa12-419f8b53db81 |
| 9 | 647200130 | ANDA | Corepharma, Llc | 2007-05-09 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040444 | 4cc84b5d-9b56-4b80-a201-6e4075727d44 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548684631 | ANDA | Physicians Total Care, Inc. | 2002-06-04 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 004068891 | ANDA040440 | d63a086a-32e2-49e2-949e-64e4c922775a |
| 2 | 680840874 | ANDA | American Health Packaging | 2014-12-04 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 001850084 | ANDA040439 | fdeb76f5-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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003784542 | ANDA | Mylan Pharmaceuticals Inc. | 2015-11-10 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA206721 | 49289133-6071-406e-8b18-73a6e4db8782 | |
| 2 | 004068884 | ANDA | Mallinckrodt, Inc. | 2010-02-18 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040440 | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | |
| 3 | 005550775 | ANDA | Barr Laboratories Inc. | 2003-03-19 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 | |
| 4 | 131070069 | ANDA | Aurolife Pharma Llc | 2013-11-27 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA202424 | a582d57f-d191-4ca5-b105-585b2d8a0e3e | |
| 5 | 576640642 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2003-09-09 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040480 | 9af67219-9b37-45d0-ac52-647cbfacd296 | |
| 6 | 578440117 | Adderall | ANDA | Teva Select Brands | 2015-03-03 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | f22635fe-821d-4cde-aa12-419f8b53db81 |
| 7 | 647200131 | ANDA | Corepharma, Llc | 2014-11-07 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040444 | 4cc84b5d-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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001850111 | ANDA | Eon Labs, Inc. | 2002-06-14 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040439 | afdedf03-f393-454d-9158-99e36071fa93 | |
| 2 | 003784543 | ANDA | Mylan Pharmaceuticals Inc. | 2015-11-10 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA206721 | 49289133-6071-406e-8b18-73a6e4db8782 | |
| 3 | 004068892 | ANDA | Mallinckrodt, Inc. | 2010-02-18 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040440 | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | |
| 4 | 005550972 | ANDA | Barr Laboratories Inc. | 2002-02-11 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 | |
| 5 | 131070070 | ANDA | Aurolife Pharma Llc | 2013-11-27 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA202424 | a582d57f-d191-4ca5-b105-585b2d8a0e3e | |
| 6 | 459630745 | ANDA | Actavis Inc. | 2014-03-31 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040456 | ffd56d70-d884-43be-a994-6e70a10e823e | |
| 7 | 576640643 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2003-09-09 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040480 | 9af67219-9b37-45d0-ac52-647cbfacd296 | |
| 8 | 578440110 | Adderall | ANDA | Teva Select Brands | 2014-02-03 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | f22635fe-821d-4cde-aa12-419f8b53db81 |
| 9 | 647200132 | ANDA | Corepharma, Llc | 2007-05-09 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040444 | 4cc84b5d-9b56-4b80-a201-6e4075727d44 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548684728 | ANDA | Physicians Total Care, Inc. | 2003-01-17 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 004068892 | ANDA040440 | d63a086a-32e2-49e2-949e-64e4c922775a | |
| 2 | 636293730 | ANDA | Bryant Ranch Prepack | 2002-02-11 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 005550972 | ANDA040422 | 6670decb-e6bb-462e-9cec-cd70fde20b58 | |
| 3 | 636293768 | Adderall | ANDA | Bryant Ranch Prepack | 1996-02-13 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 005550764 | ANDA040422 | 49b7d111-7045-4116-8988-ba93c7d63491 |
| 4 | 680840936 | ANDA | American Health Packaging | 2015-03-15 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 001850111 | ANDA040439 | fdeb76f5-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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003784544 | ANDA | Mylan Pharmaceuticals Inc. | 2015-11-10 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA206721 | 49289133-6071-406e-8b18-73a6e4db8782 | |
| 2 | 004068886 | ANDA | Mallinckrodt, Inc. | 2010-02-18 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040440 | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | |
| 3 | 005550776 | ANDA | Barr Laboratories Inc. | 2003-03-19 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 | |
| 4 | 131070071 | ANDA | Aurolife Pharma Llc | 2013-11-27 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA202424 | a582d57f-d191-4ca5-b105-585b2d8a0e3e | |
| 5 | 576640644 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2003-09-09 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040480 | 9af67219-9b37-45d0-ac52-647cbfacd296 | |
| 6 | 578440112 | Adderall | ANDA | Teva Select Brands | 2014-06-18 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | f22635fe-821d-4cde-aa12-419f8b53db81 |
| 7 | 647200133 | ANDA | Corepharma, Llc | 2014-11-07 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040444 | 4cc84b5d-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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003784545 | ANDA | Mylan Pharmaceuticals Inc. | 2015-11-10 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA206721 | 49289133-6071-406e-8b18-73a6e4db8782 | |
| 2 | 004068885 | ANDA | Mallinckrodt, Inc. | 2010-02-18 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040440 | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | |
| 3 | 005550777 | ANDA | Barr Laboratories Inc. | 2003-03-19 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 | |
| 4 | 131070072 | ANDA | Aurolife Pharma Llc | 2013-11-27 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA202424 | a582d57f-d191-4ca5-b105-585b2d8a0e3e | |
| 5 | 576640645 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2003-09-09 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040480 | 9af67219-9b37-45d0-ac52-647cbfacd296 | |
| 6 | 578440115 | Adderall | ANDA | Teva Select Brands | 2014-06-30 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | f22635fe-821d-4cde-aa12-419f8b53db81 |
| 7 | 647200134 | ANDA | Corepharma, Llc | 2014-11-07 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040444 | 4cc84b5d-9b56-4b80-a201-6e4075727d44 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685387 | ANDA | Physicians Total Care, Inc. | 2005-08-11 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 004068886 | ANDA040440 | d63a086a-32e2-49e2-949e-64e4c922775a |
| 2 | 606870133 | ANDA | American Health Packaging | 2015-03-31 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 005550777 | ANDA040422 | 39ebdc79-5403-4c2e-b366-12f8491e8bca |
amphetamine aspartate 5 mg / amphetamine sulfate 5 mg / dextroamphetamine saccharate 5 mg / dextroamphetamine sulfate 5 mg oral tablet
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001850401 | ANDA | Eon Labs, Inc. | 2002-06-14 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040439 | afdedf03-f393-454d-9158-99e36071fa93 | |
| 2 | 003784546 | ANDA | Mylan Pharmaceuticals Inc. | 2015-11-10 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA206721 | 49289133-6071-406e-8b18-73a6e4db8782 | |
| 3 | 004068893 | ANDA | Mallinckrodt, Inc. | 2010-02-18 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040440 | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | |
| 4 | 005550973 | ANDA | Barr Laboratories Inc. | 2002-02-11 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 | |
| 5 | 131070073 | ANDA | Aurolife Pharma Llc | 2013-11-27 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA202424 | a582d57f-d191-4ca5-b105-585b2d8a0e3e | |
| 6 | 459630748 | ANDA | Actavis Inc. | 2014-03-31 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040456 | ffd56d70-d884-43be-a994-6e70a10e823e | |
| 7 | 576640646 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2003-09-09 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040480 | 9af67219-9b37-45d0-ac52-647cbfacd296 | |
| 8 | 578440120 | Adderall | ANDA | Teva Select Brands | 2014-02-11 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | f22635fe-821d-4cde-aa12-419f8b53db81 |
| 9 | 647200135 | ANDA | Corepharma, Llc | 2007-05-09 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040444 | 4cc84b5d-9b56-4b80-a201-6e4075727d44 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685103 | ANDA | Physicians Total Care, Inc. | 2004-07-07 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 004068893 | ANDA040440 | d63a086a-32e2-49e2-949e-64e4c922775a | |
| 2 | 636293731 | ANDA | Bryant Ranch Prepack | 2009-12-18 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 005550973 | ANDA040422 | 1714de28-482e-463f-e91f-eeaaaa83d17f | |
| 3 | 636293769 | Adderall | ANDA | Bryant Ranch Prepack | 1996-02-13 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 005550767 | ANDA040422 | b6c8d902-4d43-46b0-b96c-00d8bed1b3dd |
| 4 | 680840943 | ANDA | American Health Packaging | 2015-03-15 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 001850401 | ANDA040439 | fdeb76f5-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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001850404 | ANDA | Eon Labs, Inc. | 2002-06-14 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040439 | afdedf03-f393-454d-9158-99e36071fa93 | |
| 2 | 003784547 | ANDA | Mylan Pharmaceuticals Inc. | 2015-11-10 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA206721 | 49289133-6071-406e-8b18-73a6e4db8782 | |
| 3 | 004068894 | ANDA | Mallinckrodt, Inc. | 2010-02-18 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040440 | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | |
| 4 | 005550974 | ANDA | Barr Laboratories Inc. | 2002-02-11 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 | |
| 5 | 131070074 | ANDA | Aurolife Pharma Llc | 2013-11-27 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA202424 | a582d57f-d191-4ca5-b105-585b2d8a0e3e | |
| 6 | 459630749 | ANDA | Actavis Inc. | 2014-03-31 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040456 | ffd56d70-d884-43be-a994-6e70a10e823e | |
| 7 | 576640647 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2003-09-09 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040480 | 9af67219-9b37-45d0-ac52-647cbfacd296 | |
| 8 | 578440130 | Adderall | ANDA | Teva Select Brands | 2014-02-06 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040422 | f22635fe-821d-4cde-aa12-419f8b53db81 |
| 9 | 647200136 | ANDA | Corepharma, Llc | 2007-05-09 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | ANDA040444 | 4cc84b5d-9b56-4b80-a201-6e4075727d44 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 165900901 | ANDA | Stat Rx Usa Llc | 2009-12-18 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 005550974 | ANDA040422 | f55aba1f-9404-4a49-8e3b-7a66ce538c60 |
| 2 | 548684863 | ANDA | Physicians Total Care, Inc. | 2003-07-25 | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 004068894 | ANDA040440 | d63a086a-32e2-49e2-949e-64e4c922775a |
| 3 | 606870154 | ANDA | American Health Packaging | 2015-03-15 | AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE | ORAL | TABLET | 001850404 | ANDA040439 | f0618c47-ca45-4652-9002-4465f6bc7fe4 |
application(s)
| # | id | title | deprecated | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | ANDA040422 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | BARR LABORATORIES INC | 2002-02-11 | ANDA040422_001, ANDA040422_002, ANDA040422_003, ANDA040422_004, ANDA040422_005, ANDA040422_006, ANDA040422_007 | ||
| 2 | ANDA040439 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | SANDOZ INC | 2002-06-14 | ANDA040439_001, ANDA040439_002, ANDA040439_003, ANDA040439_004 | ||
| 3 | ANDA040440 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | MALLINCKRODT INC | 2003-10-07 | ANDA040440_001, ANDA040440_002, ANDA040440_003, ANDA040440_004, ANDA040440_005, ANDA040440_006, ANDA040440_007 | ||
| 4 | ANDA040444 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | COREPHARMA LLC | 2002-06-19 | ANDA040444_001, ANDA040444_002, ANDA040444_003, ANDA040444_004, ANDA040444_005, ANDA040444_006, ANDA040444_007 | ||
| 5 | ANDA040456 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | ACTAVIS ELIZABETH LLC | 2003-05-06 | ANDA040456_001, ANDA040456_002, ANDA040456_003, ANDA040456_004 | ||
| 6 | ANDA040472 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | True | TEVA PHARMACEUTICALS USA | 2003-09-30 | ANDA040472_001, ANDA040472_002, ANDA040472_003, ANDA040472_004 | |
| 7 | ANDA040480 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | MUTUAL PHARMACEUTICAL CO INC | 2003-09-09 | ANDA040480_001, ANDA040480_002, ANDA040480_003, ANDA040480_004, ANDA040480_005, ANDA040480_006, ANDA040480_007 | ||
| 8 | ANDA202424 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AUROLIFE PHARMA LLC | 2013-11-27 | ANDA202424_001, ANDA202424_002, ANDA202424_003, ANDA202424_004, ANDA202424_005, ANDA202424_006, ANDA202424_007 | ||
| 9 | ANDA206721 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | MYLAN PHARMACEUTICALS INC | 2015-11-10 | ANDA206721_001, ANDA206721_002, ANDA206721_003, ANDA206721_004, ANDA206721_005, ANDA206721_006, ANDA206721_007 | ||
| 10 | NDA011522 | ADDERALL 10 | True | TEVA WOMENS HEALTH INC | 1996-02-13 | p6384020 | NDA011522_007, NDA011522_008, NDA011522_009, NDA011522_010, NDA011522_011, NDA011522_012, NDA011522_013 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040422_001 | RX | AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG) | ORAL | TABLET | False | AB | 2002-02-11 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 2 | ANDA040422_002 | RX | DEXTROAMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG) | ORAL | TABLET | False | AB | 2002-02-11 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 3 | ANDA040422_003 | RX | AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG) | ORAL | TABLET | False | AB | 2002-02-11 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 4 | ANDA040422_004 | RX | AMPHETAMINE ASPARTATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG) | ORAL | TABLET | True | AB | 2002-02-11 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 5 | ANDA040422_005 | RX | AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG) | ORAL | TABLET | False | AB | 2003-03-19 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 6 | ANDA040422_006 | RX | DEXTROAMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG) | ORAL | TABLET | False | AB | 2003-03-19 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 7 | ANDA040422_007 | RX | AMPHETAMINE ASPARTATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG) | ORAL | TABLET | False | AB | 2003-03-19 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 8 | ANDA040439_001 | RX | DEXTROAMPHETAMINE SACCHARATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG) | ORAL | TABLET | False | AB | 2002-06-14 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 9 | ANDA040439_002 | RX | AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG) | ORAL | TABLET | False | AB | 2002-06-14 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 10 | ANDA040439_003 | RX | AMPHETAMINE ASPARTATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG) | ORAL | TABLET | False | AB | 2002-06-14 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 11 | ANDA040439_004 | RX | AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG) | ORAL | TABLET | False | AB | 2002-09-27 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 12 | ANDA040440_001 | RX | AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE SULFATE (1.25MG) | ORAL | TABLET | False | AB | 2003-10-07 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 13 | ANDA040440_002 | RX | AMPHETAMINE ASPARTATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG) | ORAL | TABLET | False | AB | 2003-10-07 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 14 | ANDA040440_003 | RX | DEXTROAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG) | ORAL | TABLET | False | AB | 2003-10-07 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 15 | ANDA040440_004 | RX | DEXTROAMPHETAMINE SACCHARATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG) | ORAL | TABLET | False | AB | 2003-10-07 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 16 | ANDA040440_005 | RX | AMPHETAMINE ASPARTATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG) | ORAL | TABLET | False | AB | 2003-10-07 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 17 | ANDA040440_006 | RX | AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG) | ORAL | TABLET | False | AB | 2003-10-07 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 18 | ANDA040440_007 | RX | AMPHETAMINE ASPARTATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), AMPHETAMINE SULFATE (7.5MG) | ORAL | TABLET | False | AB | 2003-10-07 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 19 | ANDA040444_001 | RX | DEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG) | ORAL | TABLET | False | AB | 2002-06-19 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 20 | ANDA040444_002 | RX | DEXTROAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG) | ORAL | TABLET | False | AB | 2002-06-19 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 21 | ANDA040444_003 | RX | AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG) | ORAL | TABLET | False | AB | 2002-06-19 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 22 | ANDA040444_004 | RX | AMPHETAMINE ASPARTATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG) | ORAL | TABLET | False | AB | 2002-06-19 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 23 | ANDA040444_005 | RX | DEXTROAMPHETAMINE SULFATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG) | ORAL | TABLET | False | AB | 2014-11-03 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 24 | ANDA040444_006 | RX | AMPHETAMINE ASPARTATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG) | ORAL | TABLET | False | AB | 2014-11-03 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 25 | ANDA040444_007 | RX | DEXTROAMPHETAMINE SACCHARATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), AMPHETAMINE ASPARTATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG) | ORAL | TABLET | False | AB | 2014-11-03 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 26 | ANDA040456_001 | RX | DEXTROAMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), AMPHETAMINE SULFATE (1.25MG) | ORAL | TABLET | False | AB | 2003-05-06 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 27 | ANDA040456_002 | RX | AMPHETAMINE ASPARTATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG) | ORAL | TABLET | False | AB | 2003-05-06 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 28 | ANDA040456_003 | RX | AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG) | ORAL | TABLET | False | AB | 2003-05-06 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 29 | ANDA040456_004 | RX | DEXTROAMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG) | ORAL | TABLET | False | AB | 2003-05-06 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 30 | ANDA040472_001 | discontinued | AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG) | ORAL | TABLET | False | 2003-09-30 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | |
| 31 | ANDA040472_002 | discontinued | DEXTROAMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG) | ORAL | TABLET | False | 2003-09-30 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | |
| 32 | ANDA040472_003 | discontinued | DEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE ASPARTATE (5MG) | ORAL | TABLET | False | 2003-09-30 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | |
| 33 | ANDA040472_004 | discontinued | DEXTROAMPHETAMINE SACCHARATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG), AMPHETAMINE SULFATE (7.5MG) | ORAL | TABLET | False | 2003-09-30 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | |
| 34 | ANDA040480_001 | RX | DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE SULFATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG) | ORAL | TABLET | False | AB | 2003-09-09 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 35 | ANDA040480_002 | RX | DEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG) | ORAL | TABLET | False | AB | 2003-09-09 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 36 | ANDA040480_003 | RX | AMPHETAMINE ASPARTATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG) | ORAL | TABLET | False | AB | 2003-09-09 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 37 | ANDA040480_004 | RX | AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG) | ORAL | TABLET | False | AB | 2003-09-09 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 38 | ANDA040480_005 | RX | DEXTROAMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), AMPHETAMINE ASPARTATE (3.75MG) | ORAL | TABLET | False | AB | 2003-09-09 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 39 | ANDA040480_006 | RX | AMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG) | ORAL | TABLET | False | AB | 2003-09-09 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 40 | ANDA040480_007 | RX | AMPHETAMINE ASPARTATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG) | ORAL | TABLET | False | AB | 2003-09-09 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 41 | ANDA202424_001 | RX | DEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), AMPHETAMINE SULFATE (1.25MG) | ORAL | TABLET | False | AB | 2013-11-27 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 42 | ANDA202424_002 | RX | DEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG) | ORAL | TABLET | False | AB | 2013-11-27 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 43 | ANDA202424_003 | RX | AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG) | ORAL | TABLET | False | AB | 2013-11-27 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 44 | ANDA202424_004 | RX | DEXTROAMPHETAMINE SACCHARATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG) | ORAL | TABLET | False | AB | 2013-11-27 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 45 | ANDA202424_005 | RX | AMPHETAMINE SULFATE (3.75MG), AMPHETAMINE ASPARTATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG) | ORAL | TABLET | False | AB | 2013-11-27 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 46 | ANDA202424_006 | RX | DEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), AMPHETAMINE SULFATE (5MG), DEXTROAMPHETAMINE SACCHARATE (5MG) | ORAL | TABLET | False | AB | 2013-11-27 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 47 | ANDA202424_007 | RX | AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), DEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG) | ORAL | TABLET | False | AB | 2013-11-27 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 48 | ANDA206721_001 | RX | AMPHETAMINE ASPARTATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG) | ORAL | TABLET | False | AB | 2015-11-10 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 49 | ANDA206721_002 | RX | DEXTROAMPHETAMINE SULFATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG) | ORAL | TABLET | False | AB | 2015-11-10 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 50 | ANDA206721_003 | RX | DEXTROAMPHETAMINE SULFATE (2.5MG), DEXTROAMPHETAMINE SACCHARATE (2.5MG), AMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG) | ORAL | TABLET | False | AB | 2015-11-10 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 51 | ANDA206721_004 | RX | DEXTROAMPHETAMINE SULFATE (3.125MG), AMPHETAMINE ASPARTATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG) | ORAL | TABLET | False | AB | 2015-11-10 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 52 | ANDA206721_005 | RX | AMPHETAMINE ASPARTATE (3.75MG), AMPHETAMINE SULFATE (3.75MG), DEXTROAMPHETAMINE SACCHARATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG) | ORAL | TABLET | False | AB | 2015-11-10 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 53 | ANDA206721_006 | RX | DEXTROAMPHETAMINE SACCHARATE (5MG), AMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG) | ORAL | TABLET | False | AB | 2015-11-10 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 54 | ANDA206721_007 | RX | DEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG), AMPHETAMINE SULFATE (7.5MG) | ORAL | TABLET | False | AB | 2015-11-10 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
| 55 | NDA011522_007 | discontinued | DEXTROAMPHETAMINE SACCHARATE (2.5MG), DEXTROAMPHETAMINE SULFATE (2.5MG), AMPHETAMINE ASPARTATE (2.5MG), AMPHETAMINE SULFATE (2.5MG) | ORAL | TABLET | False | 1996-02-13 | ADDERALL 10 | |
| 56 | NDA011522_008 | discontinued | DEXTROAMPHETAMINE SACCHARATE (5MG), DEXTROAMPHETAMINE SULFATE (5MG), AMPHETAMINE ASPARTATE (5MG), AMPHETAMINE SULFATE (5MG) | ORAL | TABLET | False | 1996-02-13 | ADDERALL 10 | |
| 57 | NDA011522_009 | discontinued | AMPHETAMINE SULFATE (1.25MG), DEXTROAMPHETAMINE SACCHARATE (1.25MG), DEXTROAMPHETAMINE SULFATE (1.25MG), AMPHETAMINE ASPARTATE (1.25MG) | ORAL | TABLET | False | 1997-05-12 | ADDERALL 10 | |
| 58 | NDA011522_010 | discontinued | DEXTROAMPHETAMINE SULFATE (7.5MG), AMPHETAMINE ASPARTATE (7.5MG), AMPHETAMINE SULFATE (7.5MG), DEXTROAMPHETAMINE SACCHARATE (7.5MG) | ORAL | TABLET | False | 1997-05-12 | ADDERALL 10 | |
| 59 | NDA011522_011 | discontinued | AMPHETAMINE SULFATE (1.875MG), DEXTROAMPHETAMINE SACCHARATE (1.875MG), AMPHETAMINE ASPARTATE (1.875MG), DEXTROAMPHETAMINE SULFATE (1.875MG) | ORAL | TABLET | False | 2000-08-31 | ADDERALL 10 | |
| 60 | NDA011522_012 | discontinued | AMPHETAMINE ASPARTATE (3.125MG), AMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SULFATE (3.125MG), DEXTROAMPHETAMINE SACCHARATE (3.125MG) | ORAL | TABLET | False | 2000-08-31 | ADDERALL 10 | |
| 61 | NDA011522_013 | discontinued | DEXTROAMPHETAMINE SACCHARATE (3.75MG), DEXTROAMPHETAMINE SULFATE (3.75MG), AMPHETAMINE ASPARTATE (3.75MG), AMPHETAMINE SULFATE (3.75MG) | ORAL | TABLET | False | 2000-08-31 | ADDERALL 10 |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p6384020 (view patent) | 2020-07-06 | NDA011522 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1714de28-482e-463f-e91f-eeaaaa83d17f (view SPL) | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE | prescription | Human Prescription | Bryant Ranch Prepack | RELABEL, REPACK | 2012-10-12 | 4 | 636293731 |
| 2 | 39ebdc79-5403-4c2e-b366-12f8491e8bca (view SPL) | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CII | prescription | Human Prescription | American Health Packaging | REPACK | 2015-03-27 | 1 | 606870133 |
| 3 | 49289133-6071-406e-8b18-73a6e4db8782 (view SPL) | prescription | Human Prescription | Mylan Pharmaceuticals Inc. | 2015-05-08 | 2 | 003784541, 003784542, 003784543, 003784544, 003784545, 003784546, 003784547 | ||
| 4 | 49b7d111-7045-4116-8988-ba93c7d63491 (view SPL) | Adderall CII (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) | prescription | Human Prescription | Bryant Ranch Prepack | RELABEL, REPACK | 2012-10-23 | 1000 | 636293768 |
| 5 | 4cc84b5d-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 only | prescription | Human Prescription | Corepharma, Llc | 2015-06-17 | 39 | 647200130, 647200131, 647200132, 647200133, 647200134, 647200135, 647200136 | |
| 6 | 6670decb-e6bb-462e-9cec-cd70fde20b58 (view SPL) | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CII | prescription | Human Prescription | Bryant Ranch Prepack | RELABEL, REPACK | 2012-10-23 | 1000 | 636293730 |
| 7 | 72ddd1c9-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 only | prescription | Human Prescription | Mallinckrodt, Inc. | 2015-04-30 | 14 | 004068884, 004068885, 004068886, 004068891, 004068892, 004068893, 004068894 | |
| 8 | 9af67219-9b37-45d0-ac52-647cbfacd296 (view SPL) | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) | prescription | Human Prescription | Caraco Pharmaceutical Laboratories, Ltd. | 2015-05-06 | 4 | 576640641, 576640642, 576640643, 576640644, 576640645, 576640646, 576640647 | |
| 9 | a582d57f-d191-4ca5-b105-585b2d8a0e3e (view SPL) | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx Only | prescription | Human Prescription | Aurolife Pharma Llc | LABEL, MANUFACTURE, PACK, RELABEL, REPACK | 2015-02-20 | 4 | 131070068, 131070069, 131070070, 131070071, 131070072, 131070073, 131070074 |
| 10 | afdedf03-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) | prescription | Human Prescription | Eon Labs, Inc. | 2015-02-17 | 14 | 001850084, 001850111, 001850401, 001850404 | |
| 11 | b6c8d902-4d43-46b0-b96c-00d8bed1b3dd (view SPL) | Adderall CII (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) | prescription | Human Prescription | Bryant Ranch Prepack | RELABEL, REPACK | 2012-10-23 | 1000 | 636293769 |
| 12 | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 (view SPL) | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS (MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT) CII | prescription | Human Prescription | Barr Laboratories Inc. | 2015-08-04 | 14 | 005550775, 005550776, 005550777, 005550971, 005550972, 005550973, 005550974 | |
| 13 | d63a086a-32e2-49e2-949e-64e4c922775a (view SPL) | CII Rx Only | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2013-07-09 | 6 | 548684631, 548684728, 548684863, 548685103, 548685387 |
| 14 | f0618c47-ca45-4652-9002-4465f6bc7fe4 (view SPL) | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII | prescription | Human Prescription | American Health Packaging | REPACK | 2015-02-26 | 1 | 606870154 |
| 15 | f22635fe-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)) | prescription | Human Prescription | Teva Select Brands | 2015-08-04 | 5 | 578440105, 578440110, 578440112, 578440115, 578440117, 578440120, 578440130 | |
| 16 | f55aba1f-9404-4a49-8e3b-7a66ce538c60 (view SPL) | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CII | prescription | Human Prescription | Stat Rx Usa Llc | relabel, repack | 2010-06-25 | 1 | 165900901 |
| 17 | fdeb76f5-e6af-4f8b-b901-731d65a70b18 (view SPL) | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TabletsCII | prescription | Human Prescription | American Health Packaging | REPACK | 2015-02-25 | 2 | 680840874, 680840936, 680840943 |
| 18 | ffd56d70-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 Only | prescription | Human Prescription | Actavis Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-02-13 | 5 | 459630743, 459630745, 459630748, 459630749 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII