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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021977
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 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s033lbl.pdf
11/14/2014 SUPPL-33 Labeling-Medication Guide 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
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