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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021938
Company: CPPI CV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUTENT SUNITINIB MALATE EQ 12.5MG BASE CAPSULE;ORAL Prescription AB Yes No
SUTENT SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL Prescription AB Yes No
SUTENT SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL Prescription AB Yes Yes
SUTENT SUNITINIB MALATE EQ 37.5MG BASE CAPSULE;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/30/2021 SUPPL-39 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021938s039lbledt.pdf
08/14/2020 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021938s037lbl.pdf
08/14/2020 SUPPL-37 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021938s037lbl.pdf
07/10/2020 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021938s038lbl.pdf
05/07/2019 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021938s036lbl.pdf
12/13/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021938s035lbl.pdf
11/16/2017 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021938s033lbl.pdf
11/16/2015 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s031lbl.pdf
04/24/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf
04/24/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf
12/19/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021938s027lbl.pdf
08/30/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf
08/30/2013 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf
11/16/2012 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf
11/16/2012 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf
11/16/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf
04/20/2012 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf
04/20/2012 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf
04/20/2012 SUPPL-19 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf
05/20/2011 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf
05/20/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf
05/20/2011 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf
07/01/2010 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf
07/01/2010 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf
07/01/2010 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf
07/01/2010 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf
03/31/2009 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021938s009lbl.pdf
03/31/2009 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021938s009lbl.pdf
11/07/2008 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf
11/07/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf
11/07/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf
02/02/2007 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf
02/02/2007 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf
02/02/2007 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf
02/02/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf
01/26/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf
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