CHANTIX از شرکت PF PRISM CV

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CHANTIX از شرکت PF PRISM CV

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-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 REMS-Modified, Labeling-Medication Guide, REMS-Assessment

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 REMS-Proposal, Labeling

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

REMS-Modified

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.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-14

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf
10/19/2009 SUPPL-11

REMS-Proposal

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s011lbl.pdf
10/19/2009 SUPPL-11

Labeling

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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