Application 065089

Type: ANDA
Sponsor: TEVA

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	200MG/5ML;EQ 28.5MG BASE/5ML	No	No
002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	FOR SUSPENSION;ORAL	400MG/5ML;EQ 57MG BASE/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25
A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065089-001	AB
A065089-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065089-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2004-05-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065089-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-05-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065089-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065089-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065089-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065089-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065089-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065089-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065089-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065089-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065089-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065089-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065089-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065089-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065089-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065089-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065089-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065089-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065089-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065089-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065089-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065089-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065089-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065089-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065089-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065089-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065089-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065089-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065089-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065089-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065089-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065089-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065089-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065089-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065089-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065089-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065089-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065089-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065089-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065089-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065089-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065089-002	AB	1	`bb7c543d1eb4…`

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	Chartwell RX, LLC	f10634cb-6505-43f1-9b70-314c58673016	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065089 application number: ANDA065089
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Teva Pharmaceuticals USA, Inc.	963e7bea-ff5d-420a-9cb2-e4aefb534b33	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065089 application number: ANDA065089 ndc (product): 0093-2279 ndc (product): 0093-2277
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	5db8df09-4e06-4681-918d-29ca6b50b3ec	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065089 application number: ANDA065089 ndc (product): 63187-770

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2277	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2277	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2277	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2277	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2279	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2279	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2279	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2279	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-3047	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	ANDA	Current
50090-3047	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	ANDA	Current
53002-0100	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-770	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Proficient Rx LP	ANDA	Current
63187-770	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Proficient Rx LP	ANDA	Current
63187-770	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Proficient Rx LP	ANDA	Current
63187-770	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Proficient Rx LP	ANDA	Current
68071-5208	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5208	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7128	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7128	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7128	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7128	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7128	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42808	ORIG	2007-06-11