FDA.reportPublic FDA data

Application 065109

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL500MG;EQ 125MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04c2088c7a36db…
2026-09-14 22:38:342026-08A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-0484e616aacf4f…
2026-08-18 06:07:402026-07A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-043f01610625f2…
2019-09-15 20:21 UTC2019-09A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065109-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-043a93d1ddd44b…

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 3 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.56fb634c-3725-4d0a-8f20-584652a1d99f2026-03-02Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.30446852-9a54-4d16-ba12-56ffd01499852026-02-27Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.d213685c-5e67-4130-b00b-7626685dfa162026-02-26Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.6a078e7d-f942-4185-a131-50215d8e0a1e2026-02-25Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLC3f9beabd-b579-460a-8ceb-789389b109f82026-02-20Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions77126eee-9534-4e80-9d11-ec78ec66c8262026-02-19Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.bcd19a89-e9dc-b85f-e053-2a95a90a6f3e2026-02-19Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.f229e8b4-7045-4c0d-9214-890c0bda3c2a2026-02-16Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a42026-02-13Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions483f6fca-e04e-4086-aa44-a361322b811d2026-02-13Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions2a376d67-0bf2-43a1-8ca3-73f90689c3392026-02-06Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLC94b7c1bb-c024-4dc6-86d4-18a17a3eafcb2026-02-04Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.776da91b-0626-1090-e053-2a91aa0a40f02026-01-28Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.16915fe9-1ac9-4ebb-afc8-eeb89144f30c2026-01-20Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.da5bfc31-5431-49b4-b21b-619712ab43a72026-01-13Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.48356a07-60b9-c844-e063-6394a90afafa2026-01-12Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.f433611c-db72-af7f-e053-2995a90a4a702026-01-05Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMRedpharm Drug2fbb57ba-08d8-0224-e063-6294a90ab6832025-12-30Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.ebf49514-0bce-ac56-e053-2a95a90ae5402025-12-22Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsccb8bfb1-1303-4c2d-9106-78684e6b859f2025-12-19Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67296-0716Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRedPharm Drug Inc.ANDACurrent