FDA.reportPublic FDA data

Application 065065

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET, CHEWABLE;ORAL200MG;EQ 28.5MG BASENoNo
002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET, CHEWABLE;ORAL400MG;EQ 57MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-18
A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-18

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-1884e616aacf4f…
2026-09-14 22:38:342026-08A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-1884e616aacf4f…
2026-08-18 06:07:402026-07A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-18caaa826d4ba7…
2026-08-18 06:07:402026-07A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065065-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2002-04-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065065-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORAL2002-04-1874a2ff9319b5…

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 5 of 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackf8bfb851-3000-4523-8584-4e9c679a97652025-08-19Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHikma Pharmaceuticals USA Inc.52ab3500-d088-4693-acea-9b83c0843f662025-08-01Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackf748b118-6d50-487a-824d-1c92ab2028c02025-07-29Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsaf4c2ea8-73bd-429b-8392-fa20fec6fb3f2025-06-18Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions9069433e-10c0-4a5a-a94a-104fe212621e2025-06-18Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.377abca8-7076-9ad0-e063-6294a90aa5dc2025-06-13Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.36efc48d-f5cf-fdb4-e063-6294a90a720b2025-06-06Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.36d60732-b6f7-c4ee-e063-6394a90a74912025-06-05Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.348f7f77-ba7e-5dd9-e063-6294a90a09912025-05-07Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Ince41387c8-2c74-4990-831f-64dc921ee1382025-05-01Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Inc7cba82f0-9886-46e9-8dbd-43a448aade292025-05-01Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNorthStar Rx LLCdf4136c0-9efd-42c3-a487-e728e8b912752025-04-03Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.31d00820-1c20-d52b-e063-6394a90ac3122025-04-02Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPb0d7eb3e-706a-482b-b106-9c137be55bb62025-04-01Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMDevatis Inc.a884cff6-bffd-41fd-904c-c694c995f3382025-03-11Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.30144e2e-d336-8fa3-e063-6394a90a60682025-03-11Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMDevatis, Inc.90d0aa94-5c32-4fb7-8561-8763810d28472025-03-11Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMDevatis, Inc.b0b2e164-e70d-471f-92ce-abdac6cb405f2025-03-10Warnings, Adverse reactionsName fallback
brand name: amoxicillin and clavulanate potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPc8030539-314f-437d-abe7-415d6e58add72025-03-01Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHikma Pharmaceuticals USA Inc.240bcdcb-31d9-40a0-87e1-bd16264a2e202025-02-28Warnings, 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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1619Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1643Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
43858-602Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-602Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-603Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-603Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30647ORIG2003-04-09