Application 065387

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	125MG/5ML	No	No
002	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	250MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065387-001	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26
A065387-002	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065387-001	AB
A065387-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065387-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065387-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065387-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065387-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065387-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065387-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065387-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065387-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065387-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065387-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065387-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065387-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065387-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065387-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065387-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065387-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065387-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065387-002	AB	1	`bb7c543d1eb4…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	669a243e-249d-4ccb-9693-66de073e53bb	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals, Inc.	88e76bdd-39f2-48c4-91ca-609511afd382	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387 ndc (product): 68788-9948 ndc (product): 68788-9949
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8dba39df-5df8-31aa-e053-2a95a90adae1	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387 ndc (product): 68071-4969
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	76f315c4-acbc-76c1-e053-2a91aa0aebcd	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387 ndc (product): 68071-4581
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387 ndc (product): 0781-6041 ndc (product): 0781-6039
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	8bac30bb-1dbc-41de-ad50-0a1883f96198	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387 ndc (product): 50090-6056
Amoxicillin	AMOXICILLIN	Proficient Rx LP	7f75de78-2228-48e0-8405-bf631ca431ab	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387 ndc (product): 63187-880
Amoxicillin	AMOXICILLIN	Proficient Rx LP	e4bd448e-7911-4ae3-b136-a66d13e2ebed	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387 ndc (product): 71205-266

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-6039	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6039	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6039	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6039	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6039	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6041	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6041	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6041	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6041	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6041	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
49999-168	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-6056	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
53002-2090	Amoxicillin	Amoxicillin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2090	Amoxicillin	Amoxicillin	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-880	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
63187-880	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
63187-880	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
63187-880	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
67253-146	Amoxicillin	Amoxicillin	DAVA Pharmaceuticals Inc	ANDA	Current
67253-148	Amoxicillin	Amoxicillin	DAVA Pharmaceuticals Inc	ANDA	Current
68071-4581	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4581	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4581	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4704	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4704	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4969	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4969	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9948	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9948	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9948	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9948	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9948	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9949	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9949	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9949	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9949	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9949	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2078	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
71205-266	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
71205-266	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
71205-266	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
71205-266	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current