FDA.reportPublic FDA data

Application 020988

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROTONIX IVPANTOPRAZOLE SODIUMINJECTABLE;IV (INFUSION)EQ 40MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLCNDACurrent
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0923ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0941Protonixpantoprazole sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0941Protonixpantoprazole sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0941Protonixpantoprazole sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-2001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLCNDACurrent
0008-2001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-2001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-2001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-2001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-2001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-2001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLCNDACurrent
0008-4001ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
55154-4225Protonixpantoprazole sodiumCardinal HealthNDACurrent
55154-4225Protonixpantoprazole sodiumCardinal HealthNDACurrent
55154-4225Protonixpantoprazole sodiumCardinal Health 107, LLCNDACurrent
55154-4234Protonixpantoprazole sodiumCardinal HealthNDACurrent
55154-4236ProtonixPANTOPRAZOLE SODIUMCardinal HealthNDACurrent
55154-4236ProtonixPANTOPRAZOLE SODIUMCardinal HealthNDACurrent
55154-4236ProtonixPANTOPRAZOLE SODIUMCardinal Health 107, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79383SUPPL 2024-08-13
79381SUPPL 2024-08-13
74815SUPPL 2023-07-20
74778SUPPL 2023-07-19
70467SUPPL2022-03-10
70423SUPPL2022-03-07
65423SUPPL2020-12-01
65368SUPPL2020-11-30
60234SUPPL2019-10-04
60226SUPPL2019-10-04
58449SUPPL2019-04-26
58437SUPPL2019-04-26
54569SUPPL2018-06-14
54506SUPPL2018-06-11
50877SUPPL2017-12-27
50840SUPPL2017-12-22
48938SUPPL2017-07-10
48930SUPPL2017-07-07
45719SUPPL2016-10-31
45654SUPPL2016-10-26
35825SUPPL2014-12-29
26410SUPPL2014-12-23
35824SUPPL2013-12-17
3980SUPPL2013-12-16
26408SUPPL2012-10-02
35823SUPPL2012-10-01
14109SUPPL2012-05-16
26409SUPPL2012-05-14
23615ORIG2011-12-20
35821SUPPL2011-12-14
26406SUPPL2011-12-13
14108SUPPL2011-06-27
26405SUPPL2011-06-09
35822SUPPL2011-05-25
26407SUPPL2011-05-25
35820SUPPL2010-09-10
3979SUPPL2010-09-08
3978SUPPL2008-01-09
35819SUPPL2005-08-08
14107SUPPL2005-08-08
3977SUPPL2005-08-08
3976SUPPL2005-08-08
14106SUPPL2004-12-08
3974SUPPL2004-12-08
3975SUPPL2004-12-02
26404SUPPL2004-10-29
26401SUPPL2004-05-07
14104SUPPL2004-05-07
26403SUPPL2004-04-07
26402SUPPL2004-04-07
35818SUPPL2004-04-05
35815SUPPL2004-04-05
14105SUPPL2004-04-05
26399SUPPL2004-03-10
35817SUPPL2004-01-15
3973SUPPL2004-01-14
3972SUPPL2004-01-14
35816SUPPL2003-12-01
3971SUPPL2003-11-26
26400SUPPL2003-11-05
26398SUPPL2003-03-10
3970SUPPL2002-10-28
35814SUPPL2001-10-19
3969SUPPL2001-10-19
41863ORIG2001-03-22
35813ORIG2001-03-22
26397ORIG2001-03-22