Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021977
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/23/2007 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021977s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021977s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021977s050,208510s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021977Orig1s050; 208510Orig1s007; 021303Orig1s038; 022063Orig1s005ltr.pdf | |
| 02/25/2022 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021303Orig1s036; 021977Orig1s048; 022063Orig1s003; 208510Orig1s005ltr.pdf | |
| 11/02/2021 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s047,208510s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021977Orig1s047;208510Orig1s004ltr.pdf | |
| 07/29/2021 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s046,208510s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021977Orig1s046; 208510Orig1s003ltr.pdf | |
| 05/19/2017 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s045,208510s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Origs045,208510Orig1s001ltr.pdf | |
| 01/28/2017 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Orig1s044ltr.pdf | |
| 01/06/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021303Orig1s032,021977Orig1s043ltr.pdf | |
| 10/14/2016 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021977s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021977Orig1s041,s042ltr.pdf | |
| 10/14/2016 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021977s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021977Orig1s041,s042ltr.pdf | |
| 12/04/2015 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2015 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s039ltr.pdf | |
| 01/30/2015 | SUPPL-37 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s036s037lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s036,s037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021977Orig1s037.pdf | |
| 01/30/2015 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s036s037lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s036,s037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021977Orig1s036.pdf | |
| 10/30/2014 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2017 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s034,208510s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Orig1s034,208510Orig1s002ltr.pdf | |
| 11/14/2014 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s033ltr.pdf | |
| 07/18/2014 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s031,s032ltr.pdf | |
| 07/18/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s031,s032ltr.pdf | |
| 12/06/2013 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s030ltr.pdf | |
| 05/14/2014 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/2013 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s028ltr.pdf | |
| 04/26/2013 | SUPPL-27 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s027lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s027ltr.pdf | |
| 11/19/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf | |
| 11/19/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf | |
| 11/19/2012 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf | |
| 09/01/2011 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021977s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021977s023ltr.pdf | |
| 01/31/2012 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977s022ltr.pdf | |
| 11/10/2010 | SUPPL-21 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf | |
| 04/15/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/2010 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf | |
| 11/10/2010 | SUPPL-18 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf | |
| 11/10/2010 | SUPPL-16 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf | |
| 04/05/2010 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s010,s015ltr.pdf | |
| 12/02/2009 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s013ltr.pdf | |
| 03/16/2011 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021977s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021977s012ltr.pdf | |
| 04/05/2010 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s010,s015ltr.pdf | |
| 11/12/2008 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021303s019,021977s008ltr.pdf |
| 05/22/2009 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s006,s007ltr.pdf | |
| 05/22/2009 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s006,s007ltr.pdf | |
| 12/10/2007 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021977s002.pdf | |
| 04/23/2008 | SUPPL-1 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021977s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021977s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021977s050,208510s007lbl.pdf | |
| 02/25/2022 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf | |
| 11/02/2021 | SUPPL-47 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s047,208510s004lbl.pdf | |
| 11/02/2021 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s047,208510s004lbl.pdf | |
| 07/29/2021 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s046,208510s003lbl.pdf | |
| 07/31/2017 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s034,208510s002lbl.pdf | |
| 05/19/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s045,208510s001lbl.pdf | |
| 01/28/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s044lbl.pdf | |
| 01/06/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s043lbl.pdf | |
| 10/14/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021977s041s042lbl.pdf | |
| 10/14/2016 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021977s041s042lbl.pdf | |
| 04/17/2015 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s039lbl.pdf | |
| 01/30/2015 | SUPPL-37 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s036s037lbledt.pdf | |
| 01/30/2015 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s036s037lbledt.pdf | |
| 11/14/2014 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s033lbl.pdf | |
| 11/14/2014 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s033lbl.pdf | |
| 07/18/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s031s032lbl.pdf | |
| 07/18/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s031s032lbl.pdf | |
| 12/06/2013 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s030lbl.pdf | |
| 06/14/2013 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s028lbl.pdf | |
| 04/26/2013 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s027lbledt.pdf | |
| 11/19/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf | |
| 11/19/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf | |
| 11/19/2012 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf | |
| 11/19/2012 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf | |
| 01/31/2012 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s022lbl.pdf | |
| 09/01/2011 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021977s023lbl.pdf | |
| 03/16/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021977s012lbl.pdf | |
| 11/10/2010 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf | |
| 11/10/2010 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf | |
| 11/10/2010 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf | |
| 11/10/2010 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf | |
| 11/10/2010 | SUPPL-16 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf | |
| 04/05/2010 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl.pdf | |
| 04/05/2010 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl.pdf | |
| 12/02/2009 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s013lbl.pdf | |
| 05/22/2009 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s006s007lbl.pdf | |
| 05/22/2009 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s006s007lbl.pdf | |
| 04/23/2008 | SUPPL-1 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021977s001lbl.pdf | |
| 12/10/2007 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977s002lbl.pdf | |
| 02/23/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977lbl.pdf |
VYVANSE
CAPSULE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;ORAL; 70MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |