Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021928
Company: PF PRISM CV
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| CHANTIX | VARENICLINE TARTRATE | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CHANTIX | VARENICLINE TARTRATE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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-Container/Carton Labels, Labeling-Package Insert |
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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s039,s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021928Orig1s041.pdf | |
| 12/16/2016 | SUPPL-40 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021928orig1s040.pdf | |
| 08/12/2016 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s039,s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021928Orig1s039.pdf | |
| 09/19/2014 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021928Orig1s038.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) Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021928Orig1s036.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) Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021928Orig1s032.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021928Orig1s021.pdf | |
| 07/22/2011 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021928Orig1s020.pdf | |
| 07/22/2011 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021928Orig1s019.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s014,021928s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021928Orig1s017.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s014,021928s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021928Orig1s014.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021928Orig1s011.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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021928Orig1s042lbl.pdf | |
| 10/16/2017 | SUPPL-42 | Labeling-Package Insert | 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 |