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 | TABLET;ORAL | Prescription | AB | Yes | No |
| CHANTIX | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/24/2025 | SUPPL-51 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021928Orig1s051lbl.pdf | |
| 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 |