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 42.

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
2026-08-18 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
2026-08-18 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 1 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMRedpharm Drug58d32be2-166e-1a64-e063-6394a90a26ea2026-08-12Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals Inc.5c14e2f3-625d-4089-a404-440b0ecf72e72026-08-11Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMAmerican Health Packaging5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452026-08-07Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLCe17e4a72-d6a4-4a83-a921-88af9ef028a62026-07-30Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMEdenbridge Pharmaceuticals LLC.a0bb76bc-094a-4d61-9bb2-2226c9da4ae92026-07-22Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.76e1839b-7462-4344-b319-001a5f57d67a2026-07-14Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMEugia US LLC9bed093a-9586-4c82-a2b7-c68f89d0faef2026-07-09Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f38a6df2-1dd4-48bf-9ec4-1113ce492e782026-07-03Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.558dc7e1-dfd5-d3d7-e063-6394a90ab9c32026-07-01Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f313159c-115a-4cf6-b32e-9ddc833fd51c2026-07-01Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLESportpharm LLCb58c376e-616b-4970-a375-52ff630e7f092026-06-29Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.5566b4b1-b4f5-4020-e063-6394a90a52572026-06-29Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLEHAWAII REPACK, INC.f85e6d64-1ddc-4f4a-86dc-0749081a6a5f2026-06-27Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMHAWAII REPACK, INC.f403c94d-68b7-43df-8c8e-c9fef3309cfc2026-06-26Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLESt. Mary's Medical Park Pharmacye1aa55ec-5e0e-3a58-e053-2a95a90abe4f2026-06-21Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack03dea010-4bae-43ab-893e-9bbddb58062d2026-06-05Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC5331f534-4724-52e8-e063-6394a90aa5482026-06-01Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC52bbab54-9f11-77bc-e063-6394a90ab4492026-05-26Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole sodiumPANTOPRAZOLE SODIUMGland Pharma Limitedc1ad8f91-3783-4139-8154-e461a53809c12026-05-19Warnings, Adverse reactionsName fallback
brand name: Pantoprazole sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack9a1159d3-b9fa-4026-962c-d3001002e6102026-05-19Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM