Application 217805

Type: ANDA
Sponsor: MICRO LABS

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
A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL			2023-12-08

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.

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	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		2023-12-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217805-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2023-12-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217805-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217805-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217805-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217805-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217805-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217805-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217805-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217805-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217805-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217805-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217805-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217805-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217805-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217805-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217805-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217805-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217805-001	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217805-001	AB	1	`a50c72e98297…`

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 6 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	Hikma Pharmaceuticals USA Inc.	6339bcdb-060f-4558-9f42-6bf7f935e138	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	a0822381-ba9a-4f80-bc4f-608301d07fd8	2025-02-27	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	f9b4d263-bc5b-6065-e053-6394a90a5e35	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Advanced Rx Pharmacy of Tennessee, LLC	f601c634-2271-2fcd-e053-2995a90aaaba	2025-02-02	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Advanced Rx Pharmacy of Tennessee, LLC	d294e4a2-8ce7-418d-e053-2a95a90ab10b	2025-02-02	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	DirectRx	cdc6d30a-754e-6672-e053-2a95a90afa7f	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	2bb03d3b-5d44-bc4a-e063-6394a90a656a	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sandoz Inc	99b7f40a-06f9-4b97-8eee-8e61e5106aad	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	abbebdc1-4410-76af-e053-2a95a90acb9c	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	d7c0a364-d5d1-432d-823b-844a2d0b6780	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	b9bcd4a4-d4ae-4460-9eff-e80439fafd6f	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	9bd9e662-0b80-45a8-906b-3dc04ee6b3ba	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Teva Pharmaceuticals USA, Inc.	e83f43dd-f79e-4166-9bee-9427e235c876	2024-12-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	67b8567a-bab7-4859-88d6-c2ea695b9f0a	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Cipla USA Inc.	db25500a-90ee-429f-991f-da511cec7882	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	fc5dc69a-3c23-49fc-b80f-1412aebc9b76	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	482511ed-4531-45ec-a4eb-c600aeb03325	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Devatis, Inc.	d25c8190-3690-4ce6-a525-21850754224d	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	aad174d9-2c46-49aa-9a62-61063f405c53	2024-09-01	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.