Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021928
Company: PF PRISM CV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHANTIX VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription None Yes No
CHANTIX VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/10/2006 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021928lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021928s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021928_s000_ChantixTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2019 SUPPL-48 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021928Orig1s048ltr.pdf
06/01/2018 SUPPL-46 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021928s045_046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021928Orig1s045s046ltr.pdf
06/01/2018 SUPPL-45 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021928s045_046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021928Orig1s045s046ltr.pdf
10/16/2017 SUPPL-42 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021928Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021928Orig1s042ltr.pdf
08/12/2016 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s039,s041ltr.pdf
12/16/2016 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s040ltr.pdf
08/12/2016 SUPPL-39 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s039,s041ltr.pdf
09/19/2014 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf
10/15/2014 SUPPL-37 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf
09/19/2014 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf
07/28/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/15/2014 SUPPL-34 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf
10/15/2014 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf
09/19/2014 SUPPL-32 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf
12/11/2012 SUPPL-31 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021928s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021928Orig1s031ltr.pdf
02/19/2013 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021928s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021928Orig1s030ltr_repl.pdf
01/20/2012 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021928s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021928s028ltr.pdf
11/09/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s025ltr.pdf
06/29/2011 SUPPL-24 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s024ltr.pdf
12/17/2010 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s023ltr.pdf
07/22/2011 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf
07/22/2011 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf
07/22/2011 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf
02/17/2011 SUPPL-18 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s018ltr.pdf
04/22/2010 SUPPL-17 Labeling-Medication Guide, REMS-Assessment, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s014,021928s017ltr.pdf
02/04/2010 SUPPL-15 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s015ltr.pdf
04/22/2010 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s014,021928s017ltr.pdf
07/01/2009 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s012,s013ltr.pdf
07/01/2009 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s012,s013ltr.pdf
10/19/2009 SUPPL-11 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s011ltr.pdf
05/16/2008 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021928s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021928s008ltr.pdf
01/31/2008 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021928s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021928s007ltr.pdf
11/20/2007 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021928s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021928s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/22/2019 SUPPL-48 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf
06/01/2018 SUPPL-46 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021928s045_046lbl.pdf
06/01/2018 SUPPL-45 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021928s045_046lbl.pdf
10/16/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021928Orig1s042lbl.pdf
10/16/2017 SUPPL-42 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021928Orig1s042lbl.pdf
12/16/2016 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s040lbl.pdf
08/12/2016 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf
08/12/2016 SUPPL-39 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf
10/15/2014 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf
10/15/2014 SUPPL-34 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf
10/15/2014 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf
09/19/2014 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf
09/19/2014 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf
09/19/2014 SUPPL-32 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf
02/19/2013 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021928s030lbl.pdf
12/11/2012 SUPPL-31 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021928s031lbl.pdf
01/20/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021928s028lbl.pdf
11/09/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s025lbl.pdf
07/22/2011 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf
07/22/2011 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf
07/22/2011 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf
12/17/2010 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s023lbl.pdf
04/22/2010 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf
04/22/2010 SUPPL-17 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf
04/22/2010 SUPPL-17 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf
04/22/2010 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf
10/19/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s011lbl.pdf
10/19/2009 SUPPL-11 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s011lbl.pdf
07/01/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf
07/01/2009 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf
05/16/2008 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021928s008lbl.pdf
01/31/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021928s007lbl.pdf
11/20/2007 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021928s003lbl.pdf
05/10/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021928lbl.pdf

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