Application 065162

Type
ANDA
Sponsor
TEVA

Application Products#

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

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
A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065162-001AB

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-1284e616aacf4f…
2026-08-18 06:07:402026-07A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-123f01610625f2…
2019-09-15 20:21 UTC2019-09A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065162-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALABRS2004-03-12f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065162-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A065162-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065162-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065162-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065162-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065162-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065162-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065162-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065162-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065162-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065162-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065162-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065162-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065162-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065162-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065162-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065162-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065162-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065162-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065162-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065162-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065162-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065162-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065162-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065162-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065162-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065162-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065162-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065162-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065162-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065162-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065162-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065162-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065162-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065162-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065162-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065162-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065162-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065162-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065162-001AB1f41ea6bd6efb…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMChartwell RX, LLC00b86913-50c8-443f-8467-f4f499d358af2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065162
application number: ANDA065162
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMTeva Pharmaceuticals USA, Inc.e83f43dd-f79e-4166-9bee-9427e235c8762024-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065162
application number: ANDA065162
ndc (product): 0093-8675
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP3a7248ca-2855-433e-aabc-42f0bb0db1182022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065162
application number: ANDA065162
ndc (product): 63187-857

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-8675Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8675Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
45865-928Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassiummedsource pharmaceuticalsANDACurrent
50090-3293Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-3293Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50436-5166Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumUnit Dose ServicesANDACurrent
50436-8675Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumUnit Dose ServicesANDACurrent
53002-1716Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1716Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
55700-471Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
68071-4360Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4360Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4373Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4373Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4373Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8388SUPPL2010-11-10
18331SUPPL2010-10-26
22317ORIG2007-07-06