FDA.reportPublic FDA data

Application 077058

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASENoNo
002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 40MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077058-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-09-10
A077058-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-09-10

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
2026-08-01 22:54:322026-06A077058-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-09-10a50c72e98297…
2026-08-01 22:54:322026-06A077058-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-09-10a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Protonix Delayed-ReleasePANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.08098cb2-c048-4640-f387-6beec4a389362026-05-18Warnings, Adverse reactionsName fallback
generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch Prepackfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a2026-05-13Warnings, Adverse reactionsName fallback
brand name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMQPharma Inc0e200326-8885-18d0-e063-6294a90aad2f2026-05-11Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthstar Rx LLC7e0c5dac-6832-4692-b012-ca59d5e889872026-04-08Warnings, Adverse reactionsName fallback
brand name: Pantoprazole Sodium
generic name: PANTOPRAZOLE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-124PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMRebel Distributors CorpANDACurrent
50436-8101PANTOPRAZOLE SODIUMPantoprazole SodiumUnit Dose ServicesANDACurrent
53808-1047Pantoprazole SodiumPantoprazole SodiumState of Florida DOH Central PharmacyANDACurrent
58517-420PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMNew Horizon Rx Group, LLCANDACurrent
61919-866PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDirectRXANDACurrent