FDA.reportPublic FDA data

Application 217805

Type
ANDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL600MG/5ML;EQ 42.9MG BASE/5MLNoNo

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

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
A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORAL2023-12-08

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
2026-09-14 22:38:342026-08A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORAL2023-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-088072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-081c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217805-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2023-12-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217805-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217805-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217805-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217805-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217805-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217805-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217805-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217805-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217805-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217805-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217805-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217805-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217805-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217805-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217805-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217805-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217805-001AB11c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217805-001AB1a50c72e98297…

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 2 of 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceutials,Inc.e0902485-69f0-7351-e053-2a95a90aa0d02026-06-23Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.e153a542-3a3c-48ff-84cf-970832d4e8472026-06-19Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNorthwind Health Company, LLC26e1d503-ab8b-ca85-e063-6394a90aaae32026-06-18Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNorthwind Health Company, LLC1069b873-9bf9-cb22-e063-6394a90a4feb2026-06-18Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.92ff1408-512c-d68d-e053-2a95a90adfbd2026-06-18Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.ca664448-12fb-0c6f-e053-2995a90a262c2026-06-12Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMMicro Labs Limited0c2d1fbc-f80c-4737-a15e-9cfa6bf997692026-06-09Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPe08c1bee-14c8-4bd1-898c-1874251dadf82026-06-01Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack263a2902-f85c-46b6-8d5b-8c99f5c4b7062026-05-27Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMRedpharm Drug5250085e-5509-c577-e063-6294a90a9b872026-05-21Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMCoupler LLC513b6211-c73b-7e66-e063-6394a90a2aa12026-05-07Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMCoupler LLC5102cf09-9c52-ede4-e063-6394a90abd462026-05-04Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLCfabeca32-3f26-4b65-b8b6-5f0e23765ab02026-04-24Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLCcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272026-04-24Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.7ef8592d-c7d0-49a4-a559-3190e559fa2f2026-03-20Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackdfdde253-44b8-4074-b759-7bc40ea26cf92026-03-12Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAmerican Health Packaging4966a3f2-eed2-4081-ba88-310a3d1964b42026-03-06Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.fc31a5df-aa1c-4b0f-8c64-a14236df4a022026-03-05Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.720ee5cf-1962-423b-ac81-6dd4f02b92062026-03-04Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals, Inc.22a387bd-92ce-4ebc-b475-20d7750a25072026-03-04Warnings, 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.