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POTASSIUM	TABLET;ORAL	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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POTASSIUM	TABLET;ORAL	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 44.

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CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-08-06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CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-08-06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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1984-08-06	`74a2ff9319b5…`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N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1984-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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