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 7 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	474c822b-dc3d-4a55-8159-2b4b799d535b	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	5d074fe6-1ee0-40d8-e053-2a91aa0a7549	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NorthStar Rx LLC	f0a6d21d-203f-4fde-b010-a2730b86b491	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	46921419-9fae-4f51-b1b2-dc2e1ab04e8e	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	a0ff848d-230a-ab6b-e053-2a95a90a8bb8	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	9263495c-310a-c20e-e053-2995a90a2e87	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	a94cfba3-27ed-46a3-81ef-e9b80187c207	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	64a27ad7-4d32-69c8-e053-2a91aa0aa967	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	6542fa18-6219-602f-e053-2991aa0a54d0	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	6635fda2-15c3-2ff5-e053-2991aa0a5abb	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Teva Pharmaceuticals USA, Inc.	963e7bea-ff5d-420a-9cb2-e4aefb534b33	2024-06-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	917a76e9-eb2b-4d49-9418-ff919a73cfad	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	71812ac4-9264-49f2-b9ab-ea1efd1af452	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	2718248d-d948-466e-959b-1a972519f108	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	00cf4429-e37c-4490-b22d-3cd796124296	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Medsource Pharmaceuticals	12a00e7e-80f5-7c5e-e063-6394a90a68d2	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Medsource Pharmaceuticals	1275ad58-c53f-20d0-e063-6394a90a4a43	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	0d40bc70-8f47-48c2-a7c6-ba7db9cace74	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	61f9224b-a91b-4154-a7f3-22c14601230f	2023-10-31	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.