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 1.

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 / ORALAB2023-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217805-001AB

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
2026-02-19 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
2026-02-19 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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMMicro Labs Limited26992a71-e4a0-4e41-aa3c-3219868c22262025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217805
application number: ANDA217805