Application 077056

Type
ANDA
Sponsor
TEVA

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
A077056-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02
A077056-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2007-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2007-08-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02782e0a99824c…
2021-12-28 21:50 UTC2021-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077056-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077056-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077056-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077056-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077056-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077056-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077056-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077056-002AB1ea99ee380514…

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 · 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 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0011Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0011Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0011Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0012Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0012Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0012Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7916Pantoprazole SodiumPantoprazole SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7998Pantoprazole SodiumPantoprazole SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7998Pantoprazole SodiumPantoprazole SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-771Pantoprazole SodiumPantoprazole SodiumRebel Distributors CorpANDACurrent
33358-536Pantoprazole SodiumPantoprazole SodiumRxChange Co.ANDACurrent
42291-658Pantoprazole SodiumPantoprazole SodiumAvKARE, Inc.ANDACurrent
42291-658Pantoprazole SodiumPantoprazole SodiumAvKARE, Inc.ANDACurrent
42291-659Pantoprazole SodiumPantoprazole SodiumAvKARE, Inc.ANDACurrent
42291-659Pantoprazole SodiumPantoprazole SodiumAvKARE, Inc.ANDACurrent
42708-069Pantoprazole SodiumPantoprazole SodiumQPharma IncANDACurrent
42708-069Pantoprazole SodiumPantoprazole SodiumQPharma IncANDACurrent
43353-343Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-622Pantoprazole SodiumPantoprazole SodiumMedsource PharmaceuticalsANDACurrent
45865-622Pantoprazole SodiumPantoprazole SodiumMedsource PharmaceuticalsANDACurrent
50090-1415Pantoprazole SodiumPantoprazole SodiumA-S Medication SolutionsANDACurrent
50090-1415Pantoprazole SodiumPantoprazole SodiumA-S Medication SolutionsANDACurrent
50090-3095Pantoprazole SodiumPantoprazole SodiumA-S Medication SolutionsANDACurrent
51655-501Pantoprazole SodiumPantoprazole SodiumNorthwind Pharmaceuticals, LLCANDACurrent
55700-314Pantoprazole SodiumPantoprazole SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-134PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
61919-134PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
61919-134PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
61919-599PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
61919-599PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
63187-119Pantoprazole SodiumPantoprazole SodiumProficient Rx LPANDACurrent
63187-551Pantoprazole SodiumPantoprazole SodiumProficient Rx LPANDACurrent
63629-3353Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
63629-6533Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
67046-534Pantoprazole SodiumPantoprazole SodiumContract Pharmacy Services-PAANDACurrent
68071-2082Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2195Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4347Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4483Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4483Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9254Pantoprazole SodiumPantoprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9263Pantoprazole SodiumPantoprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0395Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
71610-103Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-341Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8998ORIG2006-04-25