Application 209371

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	FOR SUSPENSION;ORAL	125MG/5ML;EQ 31.25MG BASE/5ML	No	No
002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	FOR SUSPENSION;ORAL	250MG/5ML;EQ 62.5MG BASE/5ML	No	No

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

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
A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2019-04-19
A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2019-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209371-001	AB
A209371-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209371-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209371-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209371-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209371-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209371-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209371-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209371-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209371-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209371-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209371-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209371-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209371-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209371-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209371-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209371-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209371-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209371-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209371-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209371-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209371-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209371-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209371-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209371-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209371-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209371-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209371-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209371-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209371-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209371-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209371-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209371-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209371-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209371-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209371-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209371-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209371-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209371-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209371-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209371-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209371-002	AB	1	`782e0a99824c…`

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	Aurobindo Pharma Limited	3ae0c95f-7ffa-4317-9fea-4d07b86bee72	2024-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209371 application number: ANDA209371 ndc (product): 59651-026 ndc (product): 59651-025

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-025	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-025	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-025	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-025	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-025	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-026	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-026	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-026	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-026	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
59651-026	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
69043-027	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Cronus Pharma LLC	ANDA	Current
69043-027	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Cronus Pharma LLC	ANDA	Current
69043-036	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Cronus Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58815	ORIG	2019-05-21