FDA.reportPublic FDA data

Application 219973

Type
ANDA
Sponsor
SHUANGCHENG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMINJECTABLE;INTRAVENOUSEQ 40MG BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219973-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219973-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219973-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A219973-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-04-22caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219973-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219973-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A219973-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219973-001AP1a50c72e98297…

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 5 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf5c9e3c6-d4b0-0ebe-e053-2995a90abe552024-12-31Warnings, Adverse reactionsName fallback
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMFresenius Kabi USA, LLC340b57c2-bcf8-4f46-b522-886daaf803512024-12-31Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMQuality Care Products, LLCa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e22024-12-19Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMCivica, Inc.c857dc41-7b47-4f26-a9f5-d76eb82b44ee2024-10-31Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.a9f32edf-e0b9-4e96-e053-2a95a90afbc82024-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole sodiumPANTOPRAZOLE SODIUMAmerican Health Packaging423dac8b-bb1e-4456-9b6e-913c028b11bc2024-10-01Warnings, Adverse reactionsName fallback
brand name: Pantoprazole sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs6faf465b-c3a3-4ae7-9e16-1ba758f6962a2024-09-19Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMNorthStar RxLLC4494f9d0-a1c8-477f-9b4a-f65d7637d9ec2024-08-14Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.b2abc159-e450-99dc-e053-2a95a90abe6a2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals, Inc.4fbec80c-b38d-122c-e054-00144ff88e882024-07-15Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LP50a278de-bd16-417c-a741-81bfe0d745f22024-07-01Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC1c46140c-2399-5ca3-e063-6394a90af33b2024-06-27Warnings, Adverse reactionsName fallback
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.924a80b9-de48-90c0-e053-2995a90a00e12024-06-19Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.8748a588-a1e5-9dfc-e053-2a95a90a846c2024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.88f408cf-1b3e-4d7a-e053-2a95a90a369f2024-06-14Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs1680b4ed-d5b0-4fd9-b1d1-04df6a2138be2024-06-12Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack7d51104d-b135-421f-8425-03b5772e71032024-05-20Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMAsclemed USA, Inc.138b30cb-6b28-450e-9e7a-42576cc765452024-05-01Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions485212d4-caee-4a55-8299-87a28d6bd8f02024-04-29Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions39ba58cc-e4ef-4b82-a0f3-9583fa123a382024-04-25Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM

Reported adverse events (FAERS/openFDA)#

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