Application 050785

Type: NDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUGMENTIN XR	AMOXICILLIN; CLAVULANATE POTASSIUM	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 62.5MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N050785-001	AUGMENTIN XR	AMOXICILLIN; CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050785-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050785-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050785-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050785-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050785-001	AB	1	`011fe1cb6892…`
2019-12-13 00:20 UTC	2019-12	N050785-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N050785-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050785-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050785-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050785-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050785-001	6746692	2020-04-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	6783773	2020-04-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	6878386	2020-04-04	U-926		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	7250176	2020-04-04	U-926		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6746692	2020-04-04		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6783773	2020-04-04		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6878386	2020-04-04	U-926		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	7250176	2020-04-04	U-926		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6746692	2020-04-04		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6783773	2020-04-04		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6878386	2020-04-04	U-926		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	7217430	2020-04-04	U-926	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	7250176	2020-04-04	U-926		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6746692	2020-04-04		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6783773	2020-04-04		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6878386	2020-04-04	U-926		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	7250176	2020-04-04	U-926		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6746692	2020-04-04		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6783773	2020-04-04		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6878386	2020-04-04	U-926		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	7217430	2020-04-04	U-926	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	7250176	2020-04-04	U-926		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6746692	2020-04-04		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6783773	2020-04-04		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6878386	2020-04-04	U-926		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	7217430	2020-04-04	U-926	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	7250176	2020-04-04	U-926		`ea99ee380514…`

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
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	USAntibiotics, LLC	45c60b69-1b65-01ed-e063-6294a90a57be	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050785 application number: NDA050785

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-220	Amoxicillin and Clavulanate Potassium	amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80738	SUPPL	2024-12-26
80706	SUPPL	2024-12-26
78379	SUPPL	2024-05-03
78355	SUPPL	2024-05-02
72567	SUPPL	2022-11-04
72550	SUPPL	2022-11-03
18247	SUPPL	2014-04-08
8290	SUPPL	2014-04-07
18246	SUPPL	2013-12-03
8289	SUPPL	2013-11-29
8288	SUPPL	2011-08-31
39333	SUPPL	2011-08-30
39334	SUPPL	2010-09-10
18245	SUPPL	2010-09-10
30542	SUPPL	2010-09-09
18244	SUPPL	2009-01-02
8287	SUPPL	2008-12-19
30541	SUPPL	2008-04-22
30540	SUPPL	2005-06-21
18243	SUPPL	2005-06-21
8286	SUPPL	2004-09-17
8285	SUPPL	2004-05-26
42737	ORIG	2003-07-06
30539	SUPPL	2003-06-08
8284	SUPPL	2003-06-08
30538	ORIG	2002-09-25
18242	ORIG	2002-09-25
53175	ORIG	1900-01-01
53174	ORIG	1900-01-01