Application 050564

Type: NDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUGMENTIN '250'	AMOXICILLIN; CLAVULANATE POTASSIUM	TABLET;ORAL	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	AUGMENTIN '500'	AMOXICILLIN; CLAVULANATE POTASSIUM	TABLET;ORAL	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N050564-001	AUGMENTIN '250'	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-08-06
N050564-002	AUGMENTIN '500'	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-08-06

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE	TABLET / ORAL	RLD	1984-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE	TABLET / ORAL	RLD	1984-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE	TABLET / ORAL	RLD	1984-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE	TABLET / ORAL	RLD	1984-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1984-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1984-08-06	`74a2ff9319b5…`

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-006	AUGMENTIN	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
43598-018	AUGMENTIN	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
43598-206	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
43598-218	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
68788-9960	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-9960	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-9960	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc.	NDA	Current
72508-006	AUGMENTIN	amoxicillin and clavulanate potassium	Neopharma Inc	NDA	Current
72508-018	AUGMENTIN	amoxicillin and clavulanate potassium	Neopharma Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78370	SUPPL	2024-05-02
78363	SUPPL	2024-05-02
71945	SUPPL	2022-08-29
71927	SUPPL	2022-08-26
30087	SUPPL	2013-01-24
7820	SUPPL	2013-01-24
17877	SUPPL	2013-01-23
17876	SUPPL	2013-01-23
30086	SUPPL	2011-10-03
17875	SUPPL	2011-09-30
30084	SUPPL	2008-12-11
38982	SUPPL	2008-12-08
7819	SUPPL	2008-06-13
17874	SUPPL	2008-06-12
30085	SUPPL	2008-04-02
38983	SUPPL	2008-03-27
7818	SUPPL	2005-08-11
7817	SUPPL	2004-09-03
30083	SUPPL	2004-06-01
30082	SUPPL	2004-05-27
7816	SUPPL	2003-08-15
22161	SUPPL	1999-08-02