pantoprazole Injectable Solution

Brand(s)
Protonix
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. (2015-01-23)
Oldest Current Product
2001-05-01
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\PANTOPRAZOLE
FDAOB
IV (INFUSION)\INJECTION\PANTOPRAZOLE SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PANTOPRAZOLE SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PANTOPRAZOLE

product(s) by strength(s)

pantoprazole 4 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000080923ProtonixNDAWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.2001-05-01PANTOPRAZOLE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA02098851e4144a-489e-436c-609a-39305f8f56ba
2000080941ProtonixNDAWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.2001-05-01PANTOPRAZOLE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA02098848f4d638-d2a1-47fa-9a81-3acda1b1b1e3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780069ANDAAkorn2012-11-08PANTOPRAZOLE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0791979f7f2a33-b3fc-44ee-960a-a9e4db7673ea

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544225ProtonixNDACardinal Health2001-05-01PANTOPRAZOLE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION000080923NDA0209883cde88e6-28f2-4cbe-8c3f-770b05cc0e1b
2551544234ProtonixNDACardinal Health2001-05-01PANTOPRAZOLE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION000080941NDA020988eee682f1-e79d-4029-9e82-5af7f4cee7b6
3551544236ProtonixNDACardinal Health2001-05-01PANTOPRAZOLE SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION000080923NDA02098850802e19-72d3-4130-8d14-eb94361b38e7

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA079197PANTOPRAZOLE SODIUMAKORN INC2012-11-08ANDA079197_001
2ANDA090296PANTOPRAZOLE SODIUMSANDOZ INC2015-07-14ANDA090296_001
3NDA020988PROTONIX IVWYETH PHARMACEUTICALS INC2001-03-22p7351723, SUBSTANCE
p8754108, SUBSTANCE
p6780881, SUBSTANCE
NDA020988_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA079197_001RXPANTOPRAZOLE SODIUM (EQ 40MG BASE/VIAL)INJECTIONFalseAP2012-11-08PANTOPRAZOLE SODIUM
2ANDA090296_001RXPANTOPRAZOLE SODIUM (EQ 40MG BASE/VIAL)INJECTIONFalseAP2015-07-14PANTOPRAZOLE SODIUM
3NDA020988_001RXPANTOPRAZOLE SODIUM (EQ 40MG BASE/VIAL)INJECTIONTrueAP2001-03-22PROTONIX IV

patent(s)

#idexpiration dateapplication(s)
1p6780881 (view patent)2021-11-17NDA020988
2p7351723 (view patent)2021-11-17NDA020988
3p8754108 (view patent)2021-11-17NDA020988

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13cde88e6-28f2-4cbe-8c3f-770b05cc0e1b (view SPL)These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V.PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous useInitial U.S. approval: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2015-09-148551544225
248f4d638-d2a1-47fa-9a81-3acda1b1b1e3 (view SPL)These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V.PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous useInitial U.S. approval: 2000prescriptionHuman PrescriptionWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-01-2331000080941
350802e19-72d3-4130-8d14-eb94361b38e7 (view SPL)These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V.PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous useInitial U.S. approval: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2015-08-143551544236
451e4144a-489e-436c-609a-39305f8f56ba (view SPL)These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V.PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous useInitial U.S. approval: 2000prescriptionHuman PrescriptionWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-01-2134000080923
55b5ddedd-d429-41a7-8573-10c3e9ad4e52 (view SPL)These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V. PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous use Initial U.S. approval: 2000prescriptionHuman PrescriptionWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-01-154000082001
69f7f2a33-b3fc-44ee-960a-a9e4db7673ea (view SPL)These highlights do not include all the information needed to use Pantoprazole Sodium for Injection safely and effectively. See full prescribing information for Pantoprazole Sodium for Injection.Pantoprazole Sodium for InjectionFor Intravenous UseInitial U.S. approval: 2000prescriptionHuman PrescriptionAkorn2013-06-073174780069
7eee682f1-e79d-4029-9e82-5af7f4cee7b6 (view SPL)These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V.PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous useInitial U.S. approval: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2015-08-194551544234
8f39b3e7d-39d2-4c8a-9974-4ab885241880 (view SPL)These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V. PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous use Initial U.S. approval: 2000prescriptionHuman PrescriptionWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-01-215000084001

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII