Application 065065

Type: ANDA
Sponsor: SANDOZ

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	No

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
A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL			2002-04-18
A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL			2002-04-18

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`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 3 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	Preferred Pharmaceuticals Inc.	1b8a6312-ae47-45fb-ba5e-eedbc176afa0	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	d23b6952-5e4c-4103-9fe0-a916b1e2e1b9	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	618953a3-0256-42ce-9155-d35325f017aa	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	56fb634c-3725-4d0a-8f20-584652a1d99f	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	30446852-9a54-4d16-ba12-56ffd0149985	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	d213685c-5e67-4130-b00b-7626685dfa16	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	6a078e7d-f942-4185-a131-50215d8e0a1e	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	3f9beabd-b579-460a-8ceb-789389b109f8	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	77126eee-9534-4e80-9d11-ec78ec66c826	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	bcd19a89-e9dc-b85f-e053-2a95a90a6f3e	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	f229e8b4-7045-4c0d-9214-890c0bda3c2a	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	a3d1c0bb-94f3-4cfb-a4c6-233cf7e519a4	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	483f6fca-e04e-4086-aa44-a361322b811d	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	2a376d67-0bf2-43a1-8ca3-73f90689c339	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	776da91b-0626-1090-e053-2a91aa0a40f0	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	16915fe9-1ac9-4ebb-afc8-eeb89144f30c	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	da5bfc31-5431-49b4-b21b-619712ab43a7	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	48356a07-60b9-c844-e063-6394a90afafa	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	f433611c-db72-af7f-e053-2995a90a4a70	2026-01-05	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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1619	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz Inc	ANDA	Current
0781-1643	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz Inc	ANDA	Current
43858-602	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz GmbH	ANDA	Current
43858-602	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz GmbH	ANDA	Current
43858-603	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz GmbH	ANDA	Current
43858-603	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz GmbH	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30647	ORIG	2003-04-09