Application 203824

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL875MG;EQ 125MG BASENoNo

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
A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203824-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-233f01610625f2…
2019-09-15 20:21 UTC2019-09A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203824-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203824-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203824-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203824-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203824-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203824-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203824-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203824-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203824-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203824-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203824-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203824-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203824-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203824-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203824-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203824-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203824-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203824-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203824-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203824-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203824-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203824-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203824-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203824-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203824-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203824-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203824-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203824-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203824-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203824-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203824-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203824-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203824-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203824-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203824-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203824-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203824-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203824-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203824-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203824-001AB1cb3db0bc1861…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.d213685c-5e67-4130-b00b-7626685dfa162026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.6a078e7d-f942-4185-a131-50215d8e0a1e2026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
ndc (product): 72789-253
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.f229e8b4-7045-4c0d-9214-890c0bda3c2a2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
ndc (product): 72789-147
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a42026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
ndc (product): 50090-3179
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.8dba4e86-5f79-0bea-e053-2a95a90a9e2d2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
ndc (product): 68071-4967
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.9015d3dc-1ab4-2582-e053-2995a90a16792025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
ndc (product): 68071-5026
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.e5b0770d-1301-498e-a4ed-41874d7bf2252025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHikma Pharmaceuticals USA Inc.52ab3500-d088-4693-acea-9b83c0843f662025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
ndc (product): 0143-9249
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPb0d7eb3e-706a-482b-b106-9c137be55bb62025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions67b8567a-bab7-4859-88d6-c2ea695b9f0a2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.9263495c-310a-c20e-e053-2995a90a2e872024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
ndc (product): 68071-5057

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9249Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9249Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9249Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
45865-980Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassiummedsource pharmaceuticalsANDACurrent
50090-3179Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-3179Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-3414Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
55700-653Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-653Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-653Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-653Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
59115-025Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
59115-025Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
61919-430AMOXICILLIN/CLAV POTAMOXICILLIN/CLAV POTDIRECT RXANDACurrent
61919-430AMOXICILLIN/CLAV POTAMOXICILLIN/CLAV POTDIRECT RXANDACurrent
61919-430AMOXICILLIN/CLAV POTAMOXICILLIN/CLAV POTDIRECT RXANDACurrent
68071-4967Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4967Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5026Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5026Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5057Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5057Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5057Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5057Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7805Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7805Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7805Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-253Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent