Application 050575

Type: NDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUGMENTIN '125'	AMOXICILLIN; CLAVULANATE POTASSIUM	FOR SUSPENSION;ORAL	125MG/5ML;EQ 31.25MG BASE/5ML	Yes	No
002	AUGMENTIN '250'	AMOXICILLIN; CLAVULANATE POTASSIUM	FOR SUSPENSION;ORAL	250MG/5ML;EQ 62.5MG BASE/5ML	Yes	Yes

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
N050575-001	AUGMENTIN '125'	AMOXICILLIN; CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06
N050575-002	AUGMENTIN '250'	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050575-001	AB
N050575-002	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 3 · 86 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	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050575-001	AUGMENTIN '125'	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1984-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050575-002	AUGMENTIN '250'	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1984-08-06	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050575-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050575-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050575-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050575-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050575-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050575-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050575-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050575-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050575-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050575-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050575-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050575-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050575-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050575-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050575-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050575-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050575-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050575-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050575-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050575-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050575-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050575-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050575-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050575-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050575-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050575-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050575-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050575-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050575-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050575-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050575-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050575-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050575-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050575-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050575-002	AB	1	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Augmentin	AMOXICILLIN AND CLAVULANATE POTASSIUM	Allegis Holdings, LLC	04a31a42-d79e-bbb4-e063-6394a90a63ee	2024-05-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050575 application number: NDA050575

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-282	Amoxicillin and Clavulanate Potassium	amoxicillin and clavulanate potassium	Rebel Distributors Corp	NDA	Current
43598-004	AUGMENTIN	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
43598-012	AUGMENTIN	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
43598-204	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
72508-004	AUGMENTIN	amoxicillin and clavulanate potassium	Neopharma Inc	NDA	Current
72508-004	AUGMENTIN	amoxicillin and clavulanate potassium	Neopharma Inc	NDA	Current
72508-012	AUGMENTIN	amoxicillin and clavulanate potassium	Neopharma Inc	NDA	Current
72508-012	AUGMENTIN	amoxicillin and clavulanate potassium	Neopharma Inc	NDA	Current
72508-204	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Neopharma Inc	NDA	Current
72508-204	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Neopharma Inc	NDA	Current
72508-204	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Neopharma Inc	NDA	Current
81964-204	AMOXICILLIN AND CLAVULANATE POTASSIUM	Amoxicillin and Clavulanate Potassium	USAntibiotics, LLC	NDA AUTHORIZED GENERIC	Current
81964-212	AMOXICILLIN AND CLAVULANATE POTASSIUM	Amoxicillin and Clavulanate Potassium	USAntibiotics, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78371	SUPPL	2024-05-02
78364	SUPPL	2024-05-02
71946	SUPPL	2022-08-29
71928	SUPPL	2022-08-26
7833	SUPPL	2013-01-24
7832	SUPPL	2013-01-24
38996	SUPPL	2013-01-23
17891	SUPPL	2013-01-23
30105	SUPPL	2011-10-04
17890	SUPPL	2011-09-30
30104	SUPPL	2008-12-11
17888	SUPPL	2008-12-08
7831	SUPPL	2008-04-02
17889	SUPPL	2008-03-27
7830	SUPPL	2004-08-12
30103	SUPPL	2004-06-07
30101	SUPPL	2004-05-27
30102	SUPPL	2003-06-08
22162	SUPPL	1999-08-02