Application 050720

Type: NDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUGMENTIN '875'	AMOXICILLIN; CLAVULANATE POTASSIUM	TABLET;ORAL	875MG;EQ 125MG BASE	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
N050720-001	AUGMENTIN '875'	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050720-001	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	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	N050720-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050720-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050720-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050720-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050720-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050720-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050720-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050720-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050720-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050720-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050720-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050720-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050720-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050720-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050720-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050720-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050720-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050720-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050720-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050720-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050720-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050720-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050720-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050720-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050720-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050720-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050720-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050720-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050720-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050720-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050720-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050720-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050720-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050720-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050720-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050720-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050720-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050720-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050720-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050720-001	AB	1	`f41ea6bd6efb…`

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 · 3 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	Preferred Pharmaceuticals Inc.	1b8a6312-ae47-45fb-ba5e-eedbc176afa0	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720 ndc (product): 68788-8307
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	00cf4429-e37c-4490-b22d-3cd796124296	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	0d40bc70-8f47-48c2-a7c6-ba7db9cace74	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-021	AUGMENTIN	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
43598-221	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current
68071-2431	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-2448	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-2475	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-3250	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	NuCare Pharmaceuticals, Inc.	NDA	Current
68071-3302	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	NuCare Pharmaceuticals, Inc.	NDA	Current
68788-8307	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-9961	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-9961	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-9961	amoxicillin and clavulanate potassium	amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc.	NDA	Current
72508-021	AUGMENTIN	amoxicillin and clavulanate potassium	Neopharma Inc	NDA	Current
72508-221	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Neopharma Inc	NDA	Current
72508-221	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Neopharma Inc	NDA	Current
72789-076	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-076	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-076	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-083	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-083	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-083	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-083	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-083	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-083	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-083	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-083	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
81964-221	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin and clavulanate potassium	USAntibiotics, LLC	NDA AUTHORIZED GENERIC	Current
81964-221	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin and clavulanate potassium	USAntibiotics, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78373	SUPPL	2024-05-02
78366	SUPPL	2024-05-02
71948	SUPPL	2022-08-29
71930	SUPPL	2022-08-26
8106	SUPPL	2013-01-24
8105	SUPPL	2013-01-24
39183	SUPPL	2013-01-23
18113	SUPPL	2013-01-23
8104	SUPPL	2011-10-03
18112	SUPPL	2011-09-30
30364	SUPPL	2008-12-11
18111	SUPPL	2008-12-08
8102	SUPPL	2008-06-13
39181	SUPPL	2008-06-12
39182	SUPPL	2008-04-16
8103	SUPPL	2008-04-10
30363	SUPPL	2005-08-11
42696	SUPPL	2004-11-22
42695	SUPPL	2004-11-22
42694	SUPPL	2004-11-22
42693	SUPPL	2004-11-22
42692	SUPPL	2004-11-22
42691	SUPPL	2004-11-22
42690	SUPPL	2004-11-22
42689	SUPPL	2004-11-22
22199	SUPPL	2004-11-22
22198	SUPPL	2004-11-22
22197	SUPPL	2004-11-22
22196	SUPPL	2004-11-22
22195	SUPPL	2004-11-22
8101	SUPPL	2004-09-03
30362	SUPPL	2004-06-01
8099	SUPPL	2004-05-27
8100	SUPPL	2003-08-15