Application 065317

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	TABLET;ORAL	875MG;EQ 125MG BASE	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
A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL			2008-10-20

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065317-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	2008-10-20	`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 4 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	Redpharm Drug	2fbb57ba-08d8-0224-e063-6294a90ab683	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	ebf49514-0bce-ac56-e053-2a95a90ae540	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	ccb8bfb1-1303-4c2d-9106-78684e6b859f	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	8dba4e86-5f79-0bea-e053-2a95a90a9e2d	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	ef2c7783-e419-288f-e053-2a95a90a628a	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	6285c4f2-c13b-49a9-e053-2991aa0a2b03	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	b509d0eb-fe01-4902-89ae-a0dc7f7c7f93	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	22cd4e96-2288-470c-9264-8058cd7db9b0	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	aa15e6f6-1eb1-41ab-b3cb-bf24d09fc882	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	b5e66987-09e3-45b2-88ba-59c8647d724e	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	eef98beb-57d9-448a-b89c-6acd6f7b443e	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	e340b67b-332e-4e0c-aebf-ad4872dc5ed4	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	cc445a39-d84c-4b76-9fb8-ae302e7cd96b	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	b04330a0-2b8d-4cf9-a08e-19007d1001ad	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	416fa58c-88fa-42aa-9195-74aeba641577	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	0425932a-f6e1-49a6-8480-720f179ace14	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	9015d3dc-1ab4-2582-e053-2995a90a1679	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	924a9ef6-5e3d-4e78-ae97-ae090f6613c0	2025-09-24	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NorthStar Rx LLC	d75b0a7e-cb9b-4102-bcac-097403b25129	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	80be54ec-2a38-4125-a1a8-e58f50800dd2	2025-08-19	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.