Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022465
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOTRIENT PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET;ORAL Prescription None Yes Yes
VOTRIENT PAZOPANIB HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Discontinued None No 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
10/19/2009 ORIG-1 Approval Type 1 - New Molecular Entity UNKNOWN Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022465lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022465s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022465s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2017 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022465Orig1s024s025ltr.pdf
05/31/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022465Orig1s024s025ltr.pdf
08/05/2016 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s023ltr.pdf
05/20/2016 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022465Orig1s022ltr.pdf
09/22/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s021ltr.pdf
04/01/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022465Orig1s020ltr.pdf
11/18/2014 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s019ltr.pdf
06/03/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022465Orig1s018ltr.pdf
11/27/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s017ltr.pdf
08/14/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf
08/14/2013 SUPPL-15 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf
08/14/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022465Orig1s014,s015,s016ltr.pdf
11/15/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465Orig1s013ltr.pdf
04/26/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf
03/20/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s011ltr.pdf
04/26/2012 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s010,s012ltr.pdf
01/12/2012 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022465s007ltr.pdf
04/21/2011 SUPPL-6 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s006ltr.pdf
10/21/2011 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf
10/21/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022465s003,005ltr.pdf
04/27/2010 SUPPL-2 REMS-Modified, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022465s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/31/2017 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf
05/31/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf
08/05/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s023lbl.pdf
05/20/2016 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022465s022lbl.pdf
09/22/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s021lbl.pdf
04/01/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbl.pdf
04/01/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022465s020lbledt.pdf
11/18/2014 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s019lbl.pdf
06/03/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022465s018lbl.pdf
11/27/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s017lbl.pdf
08/14/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf
08/14/2013 SUPPL-15 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf
08/14/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022465s014s015s016lbl.pdf
11/15/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s013lbl.pdf
04/26/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf
04/26/2012 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s-010S-012lbl.pdf
03/20/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s011lbl.pdf
01/12/2012 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022465s007lbl.pdf
10/21/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf
10/21/2011 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf
10/21/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022465s003s005lbl.pdf
04/27/2010 SUPPL-2 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf
04/27/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf
10/19/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022465lbl.pdf

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