Application 065373

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	FOR SUSPENSION;ORAL	600MG/5ML;EQ 42.9MG BASE/5ML	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2007-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065373-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065373-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065373-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065373-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065373-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065373-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065373-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065373-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065373-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065373-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065373-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065373-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065373-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065373-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065373-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065373-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065373-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065373-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065373-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065373-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065373-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065373-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065373-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065373-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065373-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065373-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065373-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065373-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065373-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065373-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065373-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065373-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065373-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065373-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065373-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065373-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065373-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065373-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065373-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065373-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065373-001	AB	1	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	fc31a5df-aa1c-4b0f-8c64-a14236df4a02	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065373 application number: ANDA065373 ndc (product): 68788-8299
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	16915fe9-1ac9-4ebb-afc8-eeb89144f30c	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065373 application number: ANDA065373
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Hikma Pharmaceuticals USA Inc.	6339bcdb-060f-4558-9f42-6bf7f935e138	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065373 application number: ANDA065373 ndc (product): 0143-9853

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9853	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9853	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9853	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
50090-0996	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	ANDA	Current
50090-0996	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	ANDA	Current
53217-220	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-538	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
59115-061	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Hikma Pharmaceutical	ANDA	Current
59115-061	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Hikma Pharmaceutical	ANDA	Current
68071-1603	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1603	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6829	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8299	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current