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 None Yes No
SUTENT SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL Prescription None Yes No
SUTENT SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL Prescription None Yes Yes
SUTENT SUNITINIB MALATE EQ 37.5MG BASE 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
01/26/2006 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021938s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021938s000_021968s000_Stutent.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2020 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021938s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021938Orig1s038ltr.pdf
05/07/2019 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021938s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021938Orig1s036ltr.pdf
12/13/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021938s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021938Orig1s035Ltr.pdf
11/16/2017 SUPPL-33 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021938s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021938Orig1s033ltr.pdf
11/16/2015 SUPPL-31 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s031ltr.pdf
10/08/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/24/2015 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s028,s029ltr.pdf
04/24/2015 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s028,s029ltr.pdf
12/19/2014 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021938s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021938Orig1s027ltr.pdf
06/11/2014 SUPPL-26 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021938Orig1s026ltr.pdf
08/30/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021938Orig1s024,s025ltr.pdf
08/30/2013 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021938Orig1s024,s025ltr.pdf
11/16/2012 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf
11/16/2012 SUPPL-22 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf
11/16/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf
04/20/2012 SUPPL-20 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938s019,s020ltr.pdf
04/20/2012 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938s019,s020ltr.pdf
05/20/2011 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf
05/20/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf
07/01/2010 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf
07/01/2010 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf
05/20/2011 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf
07/01/2010 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf
07/01/2010 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf
03/31/2009 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021938s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021938s009ltr.pdf
11/07/2008 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf
11/07/2008 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf
11/07/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf
02/02/2007 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s005_sutent.pdf
02/02/2007 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s004_sutent.pdf
02/02/2007 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s003_sutent.pdf
02/02/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s002_sutent.pdf
05/10/2006 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021938s009lbl.pdf
03/31/2009 SUPPL-9 Labeling-Container/Carton Labels 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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