Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021977
Company: SHIRE DEVELOPMENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VYVANSE LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE;ORAL Prescription None Yes No
VYVANSE LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE;ORAL Prescription None Yes No
VYVANSE LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE;ORAL Prescription None Yes Yes
VYVANSE LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE;ORAL Prescription None Yes No
VYVANSE LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE;ORAL Prescription None Yes No
VYVANSE LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE;ORAL Prescription None Yes No
VYVANSE LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE;ORAL Prescription None 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
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-Package Insert, Labeling-Medication Guide 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
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-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
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

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