Application 090227

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 62.5MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090227-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2010-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2010-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2010-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2010-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090227-001	AB	1	`011fe1cb6892…`
2019-12-13 00:20 UTC	2019-12	A090227-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090227-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090227-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090227-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090227-001	AB	1	`a50c72e98297…`

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 · 2 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	Sportpharm LLC	cd7d2c0c-bf58-457a-b3d1-bb4c167cd127	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090227 application number: ANDA090227
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sandoz Inc	e41387c8-2c74-4990-831f-64dc921ee138	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090227 application number: ANDA090227 ndc (product): 0781-1943

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1943	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz Inc	ANDA	Current
0781-1943	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz Inc	ANDA	Current
0781-1943	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz Inc	ANDA	Current
0781-1943	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Sandoz Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9263	ORIG	2010-04-23