FDA.reportPublic FDA data

Application 020931

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIKOSYNDOFETILIDECAPSULE;ORAL0.125MGYesNo
002TIKOSYNDOFETILIDECAPSULE;ORAL0.25MGYesNo
003TIKOSYNDOFETILIDECAPSULE;ORAL0.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-5800TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5800TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5800TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5800TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5800TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5810TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5810TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5810TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5810TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5810TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5820TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5820TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5820TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5820TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
0069-5820TikosyndofetilidePfizer Laboratories Div Pfizer IncNDACurrent
59762-0037DofetilidedofetilideGreenstone LLCNDACurrent
59762-0037DofetilidedofetilideGreenstone LLCNDACurrent
59762-0037DofetilidedofetilideGreenstone LLCNDACurrent
59762-0037DofetilidedofetilideGreenstone LLCNDACurrent
59762-0037DofetilidedofetilideGreenstone LLCNDACurrent
59762-0038DofetilidedofetilideGreenstone LLCNDACurrent
59762-0038DofetilidedofetilideGreenstone LLCNDACurrent
59762-0038DofetilidedofetilideGreenstone LLCNDACurrent
59762-0038DofetilidedofetilideGreenstone LLCNDACurrent
59762-0038DofetilidedofetilideGreenstone LLCNDACurrent
59762-0039DofetilidedofetilideGreenstone LLCNDACurrent
59762-0039DofetilidedofetilideGreenstone LLCNDACurrent
59762-0039DofetilidedofetilideGreenstone LLCNDACurrent
59762-0039DofetilidedofetilideGreenstone LLCNDACurrent
59762-0039DofetilidedofetilideGreenstone LLCNDACurrent
69189-5800TikosyndofetilideAvera McKennan HospitalNDACurrent
69189-5810TikosyndofetilideAvera McKennan HospitalNDACurrent
69189-5820TikosyndofetilideAvera McKennan HospitalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68756SUPPL2021-09-24
59654SUPPL2019-08-12
59653SUPPL2019-08-09
59652SUPPL2019-08-09
54288ORIG2018-05-22
50606SUPPL2017-12-06
35658SUPPL2016-03-14
13755SUPPL2016-03-14
26218SUPPL2016-03-10
3772SUPPL2016-03-10
26217SUPPL2015-11-27
3771SUPPL2015-07-15
13754SUPPL2013-12-12
3770SUPPL2013-12-09
23204ORIG2011-08-02
3769SUPPL2011-07-13
67520SUPPL2004-10-22
41818ORIG2002-04-04
35657ORIG1999-10-04
3768ORIG1999-10-04