FDA.reportPublic FDA data

Application 209463

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMPOWDER;IV (INFUSION)EQ 40MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9284Pantoprazole SodiumPantoprazole SodiumHikma Pharmaceuticals USA Inc.NDACurrent
0143-9284Pantoprazole SodiumPantoprazole SodiumHikma Pharmaceuticals USA Inc.NDACurrent
0143-9284Pantoprazole SodiumPantoprazole SodiumHikma Pharmaceuticals USA Inc.NDACurrent
0143-9284Pantoprazole SodiumPantoprazole SodiumWest-Ward Pharmaceuticals CorpNDACurrent
0143-9300Pantoprazole SodiumPantoprazole SodiumHikma Pharmaceuticals USA Inc.NDACurrent
0143-9300Pantoprazole SodiumPantoprazole SodiumHikma Pharmaceuticals USA Inc.NDACurrent
0143-9300Pantoprazole SodiumPantoprazole SodiumWest-Ward Pharmaceuticals CorpNDACurrent
55154-7477Pantoprazole SodiumPantoprazole SodiumCardinal HealthNDACurrent
55154-7477Pantoprazole SodiumPantoprazole SodiumCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74827SUPPL 2023-07-20
74784SUPPL 2023-07-19
70455SUPPL2022-03-10
70433SUPPL2022-03-07
69813SUPPL2022-01-05
65436SUPPL2020-12-01
65364SUPPL2020-11-30
63691SUPPL2020-06-24
63680SUPPL2020-06-24
55940SUPPL2018-10-15
55939SUPPL2018-10-15
55895SUPPL2018-10-11
52678ORIG2018-02-21
48906ORIG2017-07-05
48894ORIG2017-07-03