Application 065228

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	TABLET;ORAL	500MG	No	No
002	AMOXICILLIN	AMOXICILLIN	TABLET;ORAL	875MG	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
A065228-001	AMOXICILLIN	AMOXICILLIN	500MG	TABLET / ORAL	AB		2005-07-13
A065228-002	AMOXICILLIN	AMOXICILLIN	875MG	TABLET / ORAL	AB		2005-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065228-001	AB
A065228-002	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	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`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	A065228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065228-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065228-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065228-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065228-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065228-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065228-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065228-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065228-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065228-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065228-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065228-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065228-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065228-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065228-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065228-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065228-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065228-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065228-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065228-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065228-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065228-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065228-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065228-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065228-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065228-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065228-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065228-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065228-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	ad804b34-169c-44bf-a469-f1149433d96b	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065228 application number: ANDA065228
Amoxicillin	AMOXICILLIN	Direct_Rx	f98c49a3-e6bb-7fc7-e053-6394a90a9062	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065228 application number: ANDA065228
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065228 application number: ANDA065228 ndc (product): 0781-5061 ndc (product): 0781-5060
Amoxicillin	AMOXICILLIN	Proficient Rx LP	7974a666-6d1d-446b-8ea5-f7145dc66358	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065228 application number: ANDA065228 ndc (product): 71205-035

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5060	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5060	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5060	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5060	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5060	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5061	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5061	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5061	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5061	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-5061	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
21695-544	Amoxicillin	Amoxicillin	Rebel Distributors Corp.	ANDA	Current
45865-594	Amoxicillin	Amoxicillin	medsource pharmaceuticals	ANDA	Current
68071-4418	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7160	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7160	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7160	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1413	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
70518-1413	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
70518-1413	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
70518-1413	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
71205-035	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
71205-035	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
71205-035	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
71205-035	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current