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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209463-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2017-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N209463-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N209463-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2017-06-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209463-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2017-06-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209463-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2017-06-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209463-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2017-06-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N209463-001AP1c2088c7a36db…
2026-09-14 22:38:342026-08N209463-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N209463-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209463-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209463-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N209463-001AP16a471c1ec25d…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209463-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209463-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209463-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209463-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209463-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209463-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209463-001AP179d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209463-001AP1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC362229c5-7b28-4563-aa62-d97d060054802025-10-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 209463
application number: NDA209463
ndc (product): 55154-7477
Pantoprazole SodiumPANTOPRAZOLE SODIUMCivica, Inc.c857dc41-7b47-4f26-a9f5-d76eb82b44ee2024-10-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 209463
application number: NDA209463
Pantoprazole SodiumPANTOPRAZOLE SODIUMHikma Pharmaceuticals USA Inc.1e102c44-232b-4aaf-b457-2a740c47193a2023-07-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 209463
application number: NDA209463
ndc (product): 0143-9300
Pantoprazole SodiumPANTOPRAZOLE SODIUMHikma Pharmaceuticals USA Inc.b02f3f85-8f9b-4d06-8eae-73e592626f3e2023-07-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 209463
application number: NDA209463
ndc (product): 0143-9284

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

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