Application 065291

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	CAPSULE;ORAL	250MG	No	No
002	AMOXICILLIN	AMOXICILLIN	CAPSULE;ORAL	500MG	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
A065291-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		2007-02-05
A065291-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB		2007-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065291-001	AB
A065291-002	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	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`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	A065291-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065291-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065291-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065291-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065291-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065291-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065291-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065291-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065291-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065291-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065291-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065291-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065291-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065291-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065291-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065291-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065291-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065291-002	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	18a4f555-a537-4c40-9bb2-dc3bd782fa27	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 72789-254
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	96057ce7-9516-4239-9974-5e9691b44c9b	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 72789-225
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	4fb7837e-964c-4d38-a3a5-b384b1bd6e08	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 0143-9939
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	039d2677-b04f-436c-e063-6294a90ac519	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 72789-254
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	b6ea2f81-aee6-4c88-b681-50eb28e80a86	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	fd071263-b750-4831-9fc5-de112a5f685b	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 50090-0304
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	b988349d-2198-4dbb-a231-9ba37262ce28	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 50090-0301
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	364f969d-3037-4dff-b04b-304bca27442e	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 50090-0302
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	521f7a05-4e6d-447f-b38e-00c4d623703b	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 50090-0303

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
0143-9938	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9938	Amoxicillin	Amoxicillin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9939	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9939	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9939	Amoxicillin	Amoxicillin	West-Ward Pharmaceuticals Corp	ANDA	Current
10544-619	Amoxicillin	Amoxicillin	Blenheim Pharmacal, Inc.	ANDA	Current
43063-015	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-015	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-017	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-017	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-017	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-017	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0301	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-0301	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-0302	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-0303	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-0303	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-0304	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50436-7218	Amoxicillin	Amoxicillin	Unit Dose Services	ANDA	Current
55700-075	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-075	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-075	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-075	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-075	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-075	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
59115-041	Amoxicillin	Amoxicillin	Hikma Pharmaceutical	ANDA	Current
59115-041	Amoxicillin	Amoxicillin	Hikma Pharmaceutical	ANDA	Current
59115-041	Amoxicillin	Amoxicillin	Hikma Pharmaceutical	ANDA	Current
59115-042	Amoxicillin	Amoxicillin	Hikma Pharmaceutical	ANDA	Current
63874-101	Amoxicillin	Amoxicillin	Altura Pharmaceuticals, Inc.	ANDA	Current
63874-102	Amoxicillin	Amoxicillin	Altura Pharmaceuticals, Inc.	ANDA	Current
67296-0220	Amoxicillin	Amoxicillin	RedPharm Drug Inc.	ANDA	Current
67296-0986	Amoxicillin	Amoxicillin	RedPharm Drug, Inc.	ANDA	Current
67296-0986	Amoxicillin	Amoxicillin	RedPharm Drug, Inc.	ANDA	Current
68788-9032	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9033	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-310	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-310	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
72789-225	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-254	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current