Application 091569

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	TABLET;ORAL	250MG;EQ 125MG BASE	No	No
002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	TABLET;ORAL	500MG;EQ 125MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20
A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091569-001	AB
A091569-002	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 · 86 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	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A091569-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091569-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091569-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091569-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091569-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091569-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091569-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091569-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091569-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091569-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091569-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091569-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091569-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091569-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091569-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091569-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091569-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091569-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091569-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091569-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091569-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091569-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091569-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091569-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091569-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091569-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091569-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091569-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091569-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091569-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091569-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091569-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091569-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091569-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091569-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091569-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091569-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091569-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091569-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091569-002	AB	1	`74a2ff9319b5…`

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 · 13 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	NuCare Pharmaceuticals,Inc.	92ff1408-512c-d68d-e053-2a95a90adfbd	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569 ndc (product): 68071-5065
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	fabeca32-3f26-4b65-b8b6-5f0e23765ab0	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	American Health Packaging	4966a3f2-eed2-4081-ba88-310a3d1964b4	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	d23b6952-5e4c-4103-9fe0-a916b1e2e1b9	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569 ndc (product): 68788-8317
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	48356a07-60b9-c844-e063-6394a90afafa	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	f433611c-db72-af7f-e053-2995a90a4a70	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	ef2c7783-e419-288f-e053-2a95a90a628a	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569 ndc (product): 68071-2896
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	b509d0eb-fe01-4902-89ae-a0dc7f7c7f93	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NorthStar Rx LLC	d75b0a7e-cb9b-4102-bcac-097403b25129	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569 ndc (product): 16714-296 ndc (product): 16714-295
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Aurobindo Pharma Limited	ffb158a1-83ba-4100-9221-175aa986dc3e	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569 ndc (product): 65862-503 ndc (product): 65862-502 ndc (product): 65862-501
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	af4c2ea8-73bd-429b-8392-fa20fec6fb3f	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569 ndc (product): 50090-0820
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	46921419-9fae-4f51-b1b2-dc2e1ab04e8e	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569

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 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-295	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NorthStar Rx LLC	ANDA	Current
16714-295	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NorthStar Rx LLC	ANDA	Current
16714-295	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NorthStar Rx LLC	ANDA	Current
16714-296	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NorthStar Rx LLC	ANDA	Current
16714-296	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NorthStar Rx LLC	ANDA	Current
16714-296	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NorthStar Rx LLC	ANDA	Current
35356-982	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
35356-982	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
35356-982	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-0820	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	ANDA	Current
50090-0820	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	ANDA	Current
51655-158	Amoxicillan and clavulanate potassium	Amoxicillan and clavulanate potassium	Northwind Pharmaceuticals, LLC	ANDA	Current
65862-501	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-501	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-501	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-501	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-501	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-501	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-501	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-502	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-502	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-502	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-502	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-502	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-502	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-502	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
65862-503	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	ANDA	Current
68071-2896	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5065	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5065	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5065	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5065	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8317	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9725	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1141	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	REMEDYREPACK INC.	ANDA	Current
70518-1141	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	REMEDYREPACK INC.	ANDA	Current
70934-053	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-053	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-053	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-053	Amoxicillin and Clavulanate Potassium	Amoxicillin and Clavulanate Potassium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current