NDA 21928, held by Pf Prism Cv. Varenicline Tartrate.
As of Nov 14, 2026, NDA 21928 (Chantix), held by Pf Prism Cv, was first approved by FDA on May 10, 2006, with 34 approved supplements and 0 published complete response letters.
CHANTIX is indicated for use as an aid to smoking cessation treatment.
| Feb 22, 2019 | Supplement 48Efficacy (new indication or use) · Priority review | Approved | |
| Jun 1, 2018 | Supplement 46Efficacy (new indication or use) · Standard review | Approved | |
| Jun 1, 2018 | Supplement 45Efficacy (new indication or use) · Standard review | Approved | |
| Dec 16, 2016 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Aug 12, 2016 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Oct 15, 2014 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Oct 15, 2014 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2014 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2014 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Feb 19, 2013 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Dec 11, 2012 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Jul 22, 2011 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jul 22, 2011 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jul 22, 2011 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2006 | Original applicationNew molecular entity · Priority review | Approved |
| ChantixEQ 0.5MG BASE · tablet;oral | Varenicline Tartrate | RxReference drug |
| ChantixEQ 1MG BASE · tablet;oral | Varenicline Tartrate | RxReference drug |
| Jun 24, 2025 | Supplement 51Manufacturing · Standard review | Approved | |
| Feb 22, 2019 | Supplement 48Efficacy (new indication or use) · Priority review | Approved | |
| Jun 1, 2018 | Supplement 46Efficacy (new indication or use) · Standard review | Approved | |
| Jun 1, 2018 | Supplement 45Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2017 | Supplement 42Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Aug 12, 2016 | Supplement 41Labeling · Standard review | Approved | |
| Aug 12, 2016 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Oct 15, 2014 | Supplement 37Labeling · Standard review | Approved | |
| Oct 15, 2014 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Oct 15, 2014 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2014 | Supplement 38Labeling | Approved | |
| Sep 19, 2014 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2014 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2014 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Feb 19, 2013 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Dec 11, 2012 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Jan 20, 2012 | Supplement 28Labeling · Standard review | Approved | |
| Nov 9, 2011 | Supplement 25Labeling | Approved | |
| Jul 22, 2011 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jul 22, 2011 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jul 22, 2011 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 2011 | Supplement 24Labeling | Approved | |
| Feb 17, 2011 | Supplement 18Labeling | Approved | |
| Dec 17, 2010 | Supplement 23Labeling · Standard review | Approved | |
| Apr 22, 2010 | Supplement 17Labeling | Approved | |
| Apr 22, 2010 | Supplement 14Labeling · Standard review | Approved | |
| Feb 4, 2010 | Supplement 15Labeling | Approved | |
| Oct 19, 2009 | Supplement 11Labeling · Standard review | Approved | |
| Jul 1, 2009 | Supplement 13Labeling · Standard review | Approved | |
| Jul 1, 2009 | Supplement 12Labeling · Standard review | Approved | |
| May 16, 2008 | Supplement 8Labeling · Standard review | Approved | |
| Jan 31, 2008 | Supplement 7Labeling · Standard review | Approved | |
| Nov 20, 2007 | Supplement 3Labeling · Standard review | Approved | |
| May 10, 2006 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
