Application 050755

Type: NDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUGMENTIN ES-600	AMOXICILLIN; CLAVULANATE POTASSIUM	FOR SUSPENSION;ORAL	600MG/5ML;EQ 42.9MG BASE/5ML	Yes	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
N050755-001	AUGMENTIN ES-600	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050755-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	2001-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	2001-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	2001-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	2001-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050755-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050755-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050755-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050755-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050755-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050755-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050755-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050755-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050755-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050755-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050755-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050755-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050755-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050755-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050755-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050755-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050755-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050755-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050755-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N050755-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050755-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050755-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050755-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050755-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050755-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050755-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050755-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050755-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050755-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050755-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050755-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050755-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050755-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050755-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050755-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050755-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050755-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050755-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050755-001	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 1 of 1 · 4 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	USAntibiotics, LLC	7d4dfd6f-bd1a-4acc-8506-07fca08f8a38	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050755 application number: NDA050755 ndc (product): 81964-203
AUGMENTIN ES-600	AMOXICILLIN AND CLAVULANATE POTASSIUM	USAntibiotics, LLC	59979859-8c9b-4173-a5e3-2e6312fd9d79	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050755 application number: NDA050755 ndc (product): 81964-003
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Redpharm Drug	2fbb57ba-08d8-0224-e063-6294a90ab683	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050755 application number: NDA050755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	2bb03d3b-5d44-bc4a-e063-6394a90a656a	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050755 application number: NDA050755

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-600	Amoxicillin and Clavulanate Potassium	amoxicillin and clavulanate potassium	Aidarex Pharmaceuticals LLC	NDA	Current
33261-970	Amoxicillin and Clavulanate Potassium	amoxicillin and clavulanate potassium	Aidarex Pharmaceuticals LLC	NDA	Current
43598-003	AUGMENTIN ES-600	amoxicillin and clavulanate potassium	Dr Reddys Laboratories Inc	NDA	Current
68788-9310	Amoxicillin and Clavulanate Potassium	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-9847	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc	NDA	Current
72508-203	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Neopharma Inc	NDA	Current
72508-203	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Neopharma Inc	NDA	Current
81964-003	AUGMENTIN ES-600	amoxicillin and clavulanate potassium	USAntibiotics, LLC	NDA	Current
81964-003	AUGMENTIN ES-600	amoxicillin and clavulanate potassium	USAntibiotics, LLC	NDA	Current
81964-203	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin and clavulanate potassium	USAntibiotics, LLC	NDA AUTHORIZED GENERIC	Current
81964-203	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin and clavulanate potassium	USAntibiotics, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80737	SUPPL	2024-12-26
80705	SUPPL	2024-12-26
78378	SUPPL	2024-05-03
78354	SUPPL	2024-05-02
72148	SUPPL	2022-09-23
72145	SUPPL	2022-09-23
71523	SUPPL	2022-07-06
71503	SUPPL	2022-07-01
39265	SUPPL	2015-03-19
8200	SUPPL	2015-03-17
30459	SUPPL	2011-08-31
8199	SUPPL	2011-08-31
39264	SUPPL	2011-08-30
39263	SUPPL	2011-08-30
8197	SUPPL	2009-01-26
39262	SUPPL	2009-01-16
8198	SUPPL	2008-04-22
22222	SUPPL	2005-06-27
22223	SUPPL	2005-02-04
39261	SUPPL	2004-12-30
8196	SUPPL	2004-12-30
30458	SUPPL	2004-11-16
39260	SUPPL	2004-07-27
30457	SUPPL	2004-06-07
22221	ORIG	2004-05-27
30456	SUPPL	2003-06-08
39259	ORIG	2001-06-26
30455	ORIG	2001-06-26