Application 205187

Type: ANDA
Sponsor: MICRO LABS LTD INDIA

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	200MG/5ML;EQ 28.5MG BASE/5ML	No	No
002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	FOR SUSPENSION;ORAL	400MG/5ML;EQ 57MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2021-05-21
A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2021-05-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205187-001	AB
A205187-002	AB

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 · 68 observed 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
2026-08-18 06:07:40	2026-07	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205187-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205187-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2021-05-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205187-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205187-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205187-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205187-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205187-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205187-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205187-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205187-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205187-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205187-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205187-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205187-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205187-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205187-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205187-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205187-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205187-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205187-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205187-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205187-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205187-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205187-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205187-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205187-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205187-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205187-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205187-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205187-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205187-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205187-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205187-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205187-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205187-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205187-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205187-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205187-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205187-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205187-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205187-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205187-002	AB	1	`782e0a99824c…`

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 1 of 9 · 164 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	REMEDYREPACK INC.	c88b2b50-c664-43b3-9c37-f134a329dc21	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	80bef3fd-4f6f-4190-8865-9ac46c8947a3	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	a1d6bf78-4bb7-469e-ba39-318e14aaee29	2026-08-13	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	fbd40fcd-bf5b-e91e-e053-6394a90a609c	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	a26f2ceb-bb9b-4813-9691-634338186860	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	2c7a4de8-002a-472c-90d8-4c39a1f188c3	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	1bda03a2-6c7d-4c9e-b98a-e5e01bebb3b1	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	7526a33a-18d6-36ca-e053-2a91aa0ab9f9	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin and clavulanate potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Chartwell RX, LLC	f10634cb-6505-43f1-9b70-314c58673016	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: amoxicillin and clavulanate potassium
amoxicillin and clavulanate potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Chartwell RX, LLC	00b86913-50c8-443f-8467-f4f499d358af	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: amoxicillin and clavulanate potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	77b82fac-3f6e-44c9-8dcc-362f01ad7a4b	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	1127a41b-14a1-4fe8-ae37-67ea5d760301	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	6e1c6209-660f-4043-b6a6-eac5f7665ef9	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	HAWAII REPACK, INC.	7fb0f56e-c098-49e4-b075-2eb8936582aa	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	USAntibiotics, LLC	7d4dfd6f-bd1a-4acc-8506-07fca08f8a38	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	USAntibiotics, LLC	45c60b69-1b65-01ed-e063-6294a90a57be	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	USAntibiotics, LLC	c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	ce488c24-2ec5-4d1b-b446-90f2497aa15d	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	aa77bab1-1c08-43bf-a943-0399646b3e1c	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceutials,Inc.	e0902485-69f0-7351-e053-2a95a90aa0d0	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin and Clavulanate Potassium

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
42571-163	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Micro Labs Limited	ANDA	Current
42571-163	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Micro Labs Limited	ANDA	Current
42571-163	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Micro Labs Limited	ANDA	Current
42571-164	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Micro Labs Limited	ANDA	Current
42571-164	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Micro Labs Limited	ANDA	Current
42571-164	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Micro Labs Limited	ANDA	Current