Application 065205

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	TABLET, CHEWABLE;ORAL	200MG;EQ 28.5MG BASE	No	No
002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	TABLET, CHEWABLE;ORAL	400MG;EQ 57MG BASE	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL			2005-02-09
A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL		RS	2005-02-09

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065205-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL		2005-02-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065205-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	RS	2005-02-09	`74a2ff9319b5…`

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 8 of 8 · 157 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	Proficient Rx LP	e05caabb-b95c-4e54-890e-bbc371a20fc3	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	f14a8008-c0ff-4628-af99-e5f07b19df71	2023-09-06	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	8c4125d4-d074-40d4-9def-d3a528fc8c8e	2023-09-06	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	029a49f2-2132-4160-a0d6-2d108a456a22	2023-03-02	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	f05a27dd-5ced-4f62-8a0c-548c3a033f5e	2022-12-13	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	a0d22635-0e11-448d-b151-6f6168c65723	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	1e91c5ce-3482-47ca-92e7-e492196992d9	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	3a7248ca-2855-433e-aabc-42f0bb0db118	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	f17fddd3-aecc-456c-9b2b-f33b7fdb353e	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	5db8df09-4e06-4681-918d-29ca6b50b3ec	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	5b68b2bf-b581-4372-87be-a6394ee56961	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	f636413f-82e5-446f-94cc-b4841bdedb33	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	bb75eb89-2579-4189-8dd2-40ae8727fe7c	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	bf29327f-4e43-4597-83d2-f64349bf9d9a	2020-09-01	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	4655e0ea-f7d5-4f7c-bf7b-266337bc05b8	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
amoxicillin and clavulanate potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	1f252ad3-373c-4a6d-96e7-53ba820d201b	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: amoxicillin and clavulanate potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	01b30abb-db63-4257-9fe2-9107bb0bd69c	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2270	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2270	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2270	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2270	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2272	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2272	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2272	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2272	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42814	ORIG	2008-07-31