FDA.reportPublic FDA data

Application 021928

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHANTIXVARENICLINE TARTRATETABLET;ORALEQ 0.5MG BASEYesNo
002CHANTIXVARENICLINE TARTRATETABLET;ORALEQ 1MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0468CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0468CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0468CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0468CHANTIXvarenicline tartratePfizer Labs, Division of Pfizer Inc.NDACurrent
0069-0468CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0468CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0469CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0469CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0469CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0469CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0469CHANTIXvarenicline tartratePfizer Labs, Division of Pfizer Inc.NDACurrent
0069-0469CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0471CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0471CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0471CHANTIXvarenicline tartratePfizer Labs, Division of Pfizer Inc.NDACurrent
0069-0471CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0471CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0471CHANTIXvarenicline tartratePfizer Laboratories Div Pfizer IncNDACurrent
21695-633Chantixvarenicline tartrateRebel Distributors CorpNDACurrent
21695-945CHANTIXvarenicline tartrateRebel Distributors CorpNDACurrent
21695-946Chantixvarenicline tartrateRebel Distributors CorpNDACurrent
43353-899CHANTIXvarenicline tartrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
50090-0995CHANTIXvarenicline tartrateA-S Medication SolutionsNDACurrent
50090-0995CHANTIXvarenicline tartrateA-S Medication SolutionsNDACurrent
50090-0998CHANTIXvarenicline tartrateA-S Medication SolutionsNDACurrent
50090-0998CHANTIXvarenicline tartrateA-S Medication SolutionsNDACurrent
50090-3528CHANTIXvarenicline tartrateA-S Medication SolutionsNDACurrent
50090-4481CHANTIXvarenicline tartrateA-S Medication SolutionsNDACurrent
50090-4481CHANTIXvarenicline tartrateA-S Medication SolutionsNDACurrent
50090-4482CHANTIXvarenicline tartrateA-S Medication SolutionsNDACurrent
63187-618CHANTIXvarenicline tartrateProficient Rx LPNDACurrent
63187-618CHANTIXvarenicline tartrateProficient Rx LPNDACurrent
63187-618CHANTIXvarenicline tartrateProficient Rx LPNDACurrent
63539-473CHANTIXvarenicline tartrateU.S. PharmaceuticalsNDACurrent
63539-473CHANTIXvarenicline tartrateU.S. PharmaceuticalsNDACurrent
63539-473CHANTIXvarenicline tartrateU.S. PharmaceuticalsNDACurrent
63539-473CHANTIXvarenicline tartrateU.S. PharmaceuticalsNDACurrent
63539-473CHANTIXvarenicline tartrateU.S. PharmaceuticalsNDACurrent
68151-4952CHANTIXvarenicline tartrateCarilion Materials ManagementNDACurrent
68151-4953CHANTIXvarenicline tartrateCarilion Materials ManagementNDACurrent
69189-0492CHANTIXvarenicline tartrateAvera McKennan HospitalNDACurrent
71205-381CHANTIXvarenicline tartrateProficient Rx LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82879SUPPL 2025-07-16
82878SUPPL 2025-07-15
82877SUPPL 2025-07-15
65822SUPPL2021-01-06
65819SUPPL2021-01-06
65818SUPPL2021-01-06
65817SUPPL2021-01-06
65816SUPPL2021-01-06
64839SUPPL2020-10-06
64838SUPPL2020-10-06
64837SUPPL2020-10-06
64836SUPPL2020-10-06
64835SUPPL2020-10-06
64834SUPPL2020-10-06
64832SUPPL2020-10-06
57789SUPPL2019-02-22
57753SUPPL2019-02-22
57752SUPPL2019-02-22
54428SUPPL2018-06-04
54427SUPPL2018-06-04
54416SUPPL2018-06-01
54415SUPPL2018-06-01
50094SUPPL2017-10-18
50091SUPPL2017-10-18
46450SUPPL2016-12-21
46266SUPPL2016-12-20
45079SUPPL2016-08-17
45078SUPPL2016-08-17
45127SUPPL2016-08-12
45126SUPPL2016-08-12
37902SUPPL2014-10-16
28872SUPPL2014-10-16
16597SUPPL2014-10-16
16596SUPPL2014-10-16
6483SUPPL2014-10-16
6481SUPPL2014-10-16
28871SUPPL2014-09-24
6484SUPPL2014-09-24
6482SUPPL2014-09-24
37903SUPPL2014-09-22
37901SUPPL2014-09-22
16595SUPPL2014-09-22
28869SUPPL2013-03-15
16593SUPPL2013-02-21
28870SUPPL2012-12-13
16594SUPPL2012-12-13
6480SUPPL2012-01-25
16592SUPPL2012-01-24
28868SUPPL2011-11-14
37900SUPPL2011-11-10
37899SUPPL2011-07-22
37898SUPPL2011-07-22
28866SUPPL2011-07-22
28865SUPPL2011-07-22
16590SUPPL2011-07-22
6478SUPPL2011-07-22
6479SUPPL2011-07-06
28864SUPPL2011-02-24
28867SUPPL2010-12-22
16591SUPPL2010-12-22
37897SUPPL2010-05-03
37896SUPPL2010-05-03
6477SUPPL2010-04-27
6475SUPPL2010-04-27
6476SUPPL2010-02-17
6474SUPPL2009-11-25
6472SUPPL2009-11-24
37894SUPPL2009-10-21
37895SUPPL2009-07-09
16589SUPPL2009-07-09
6473SUPPL2009-07-08
6471SUPPL2008-05-21
16588SUPPL2008-05-16
28863SUPPL2008-02-04
16587SUPPL2008-02-01
37893SUPPL2007-11-26
28862SUPPL2007-11-26
23685ORIG2006-09-01
21874ORIG2006-06-16
16586ORIG2006-05-16
6470ORIG2006-05-16
53437ORIG1900-01-01