Application 202038

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
A202038-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28
A202038-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202038-001AB
A202038-002AB

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 UTC2026-02A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202038-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202038-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202038-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202038-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202038-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202038-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202038-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202038-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202038-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202038-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202038-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202038-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202038-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202038-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202038-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202038-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202038-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202038-002AB1782e0a99824c…

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.76e1839b-7462-4344-b319-001a5f57d67a2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
ndc (product): 70518-1788
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f38a6df2-1dd4-48bf-9ec4-1113ce492e782026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
ndc (product): 70518-1298
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.558dc7e1-dfd5-d3d7-e063-6394a90ab9c32026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f313159c-115a-4cf6-b32e-9ddc833fd51c2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.5566b4b1-b4f5-4020-e063-6394a90a52572026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMHAWAII REPACK, INC.f403c94d-68b7-43df-8c8e-c9fef3309cfc2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack03dea010-4bae-43ab-893e-9bbddb58062d2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
ndc (product): 71335-1165
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC5331f534-4724-52e8-e063-6394a90aa5482026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC52bbab54-9f11-77bc-e063-6394a90ab4492026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack9a1159d3-b9fa-4026-962c-d3001002e6102026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
ndc (product): 71335-0310
Pantoprazole SodiumPANTOPRAZOLE SODIUMQPharma Inc0e200326-8885-18d0-e063-6294a90aad2f2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMAurobindo Pharma Limited7418f358-f536-4de6-adf0-562b4373f2e32026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthStar Rx LLC6637d90b-b268-4a5f-ab5b-885f2d5f0d4b2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBurel Pharmaceuticals, LLC3cc5197e-6b39-4415-b963-d4bbeecd79532026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC6229247e-ee15-466e-a8ac-adcd646b738d2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMMajor Pharmaceuticalsde419aa0-caa9-40fb-bc6d-e341c94273c72026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthwind Health Company, LLCf2a1af50-a051-3e55-e053-2a95a90a91842026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthwind Health Company, LLCd9deb251-96d3-5f96-e053-2a95a90a07922026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.8aac1642-6cb0-6ad2-e053-2a95a90a4cbd2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMQuality Care Products, LLCa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e22024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 103 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1298Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1298Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1298Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1788Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1788Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1788Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1788Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1788Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1788Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1788Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-1788Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
70934-102Pantoprazole SodiumPantoprazole SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-102Pantoprazole SodiumPantoprazole SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-102Pantoprazole SodiumPantoprazole SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0310Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
71335-0310Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
71335-0310Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
71335-1165Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
71335-1165Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
71335-1165Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
71610-003Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-227Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-340Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent