Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 0.5MG BASE | 1 | CHANTIX | VARENICLINE TARTRATE |
| 002 | TABLET;ORAL | EQ 1MG BASE | 1 | CHANTIX | VARENICLINE TARTRATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2006-05-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2007-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2008-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2008-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2009-07-01 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2009-07-01 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2010-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2010-02-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2010-04-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2011-02-17 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2011-07-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2011-07-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2011-07-22 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2010-12-17 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2011-06-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 25 | AP | 2011-11-09 | UNKNOWN |
| LABELING; Labeling | SUPPL | 28 | AP | 2012-01-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2013-02-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 2012-12-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 32 | AP | 2014-09-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2014-10-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 34 | AP | 2014-10-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2014-07-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2014-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2014-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2014-09-19 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 39 | AP | 2016-08-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 40 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2016-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2017-10-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 45 | AP | 2018-06-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 46 | AP | 2018-06-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 48 | AP | 2019-02-22 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 15 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 48 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
PF PRISM CV
cder:Array
(
[0] => Array
(
[ApplNo] => 21928
[companyName] => PF PRISM CV
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021928s048lbl.pdf#page=22"]
[products] => [{"drugName":"CHANTIX","activeIngredients":"VARENICLINE TARTRATE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CHANTIX","activeIngredients":"VARENICLINE TARTRATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
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[originalApprovals] => [{"actionDate":"CHANTIX","submission":"VARENICLINE TARTRATE","actionType":"EQ 0.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CHANTIX","submission":"VARENICLINE TARTRATE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-02-22
)
)