FDA.reportPublic FDA data

Application 020987

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROTONIXPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 40MG BASEYesYes
002PROTONIXPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-0841ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0841ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0841ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0841ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0843ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0843ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0843ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-0843ProtonixPANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
21695-108Protonixpantoprazoel sodiumRebel Distributors CorpNDACurrent
43353-338Pantoprazole Sodiumpantoprazole sodiumAphena Pharma Solutions - Tennessee, LLCNDACurrent
63187-005Pantoprazole Sodiumpantoprazole sodiumProficient RxNDACurrent
67046-535Pantoprazole Sodiumpantoprazole sodiumContract Pharmacy Services-PANDACurrent
67296-0029ProtonixPANTOPRAZOLE SODIUMRedPharm Drug, Inc.NDACurrent
69189-0841ProtonixPANTOPRAZOLE SODIUMAvera McKennan HospitalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74812SUPPL 2023-07-20
74811SUPPL 2023-07-20
74793SUPPL 2023-07-19
70448SUPPL2022-03-09
70445SUPPL2022-03-09
70421SUPPL2022-03-07
65417SUPPL2020-11-30
65416SUPPL2020-11-30
65377SUPPL2020-11-30
60233SUPPL2019-10-04
60227SUPPL2019-10-04
58448SUPPL2019-04-26
58445SUPPL2019-04-26
58436SUPPL2019-04-26
54571SUPPL2018-06-14
54504SUPPL2018-06-11
50876SUPPL2017-12-27
50838SUPPL2017-12-22
48957SUPPL2017-07-12
48949SUPPL2017-07-11
48940SUPPL2017-07-10
45718SUPPL2016-10-31
45658SUPPL2016-10-26
14103SUPPL2014-12-29
3968SUPPL2014-12-24
26396SUPPL2013-12-13
35812SUPPL2013-12-11
14102SUPPL2012-10-15
26395SUPPL2012-10-11
35811SUPPL2012-05-15
23614ORIG2011-12-20
14101SUPPL2011-11-01
3966SUPPL2011-10-31
35810SUPPL2011-05-25
3967SUPPL2011-05-25
14100SUPPL2010-09-10
3965SUPPL2010-09-08
26394SUPPL2009-11-25
3964SUPPL2009-11-25
35809SUPPL2009-11-16
14099SUPPL2009-11-16
3963SUPPL2008-01-09
26393SUPPL2006-07-27
26392SUPPL2004-12-02
35807SUPPL2004-05-07
3960SUPPL2004-05-07
35808SUPPL2004-04-05
14097SUPPL2004-04-05
26391SUPPL2004-03-16
26390SUPPL2004-03-10
14098SUPPL2004-01-15
3962SUPPL2004-01-14
3961SUPPL2004-01-14
35805SUPPL2003-04-25
35804SUPPL2003-04-09
3959SUPPL2002-10-28
35806SUPPL2002-04-19
21331SUPPL2002-04-19
3958SUPPL2002-04-19
26389SUPPL2001-06-12
3957SUPPL2001-06-12
41862ORIG2000-02-02
14096ORIG2000-02-02
3956ORIG2000-02-02