Application 065325

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	400MG/5ML	No	No
002	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	200MG/5ML	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
A065325-001	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2006-06-19
A065325-002	AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2006-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065325-001	AB
A065325-002	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A065325-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065325-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065325-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065325-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065325-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065325-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065325-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065325-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065325-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065325-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065325-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065325-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065325-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065325-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065325-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065325-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065325-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065325-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065325-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065325-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065325-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065325-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065325-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065325-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065325-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065325-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065325-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065325-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065325-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065325-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065325-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065325-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065325-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065325-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065325-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065325-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065325-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065325-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065325-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065325-002	AB	1	`f41ea6bd6efb…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	afef7c71-2d19-41ed-9213-b32ccc1bf1d3	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 68788-7323
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	c0e333d9-164d-4196-b5f5-929993d1c3c2	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	992d7829-34d1-4c88-8a5c-1a92d001d194	2025-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxil	AMOXICILLIN ORAL SUSP	DirectRx	ec7dd735-dc92-3d29-e053-2a95a90af549	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 72189-385
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	59a546ed-84b7-a54a-e053-2991aa0a3a0d	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 68071-1675
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8398f2c9-37ca-9b59-e053-2991aa0a2c11	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 68071-4796
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 0143-9886 ndc (product): 0143-9887
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	cef5b1ae-8454-4e7a-8830-dd5d601c1d21	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 50090-0858
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	156ef8e9-b6e4-4512-865f-7139c90c8f9b	2023-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 50090-1347
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	77265bcd-c05d-443a-84c4-6e5ac75ee42c	2023-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 50090-1086
Amoxicillin	AMOXICILLIN	Proficient Rx LP	756545f1-77af-49a0-a697-4cced31711d4	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 71205-422

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 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9886	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9886	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9886	Amoxicillin	Amoxicillin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9887	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9887	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9887	Amoxicillin	Amoxicillin	West-Ward Pharmaceuticals Corp	ANDA	Current
42254-139	Amoxicillin	Amoxicillin	Rebel Distributors Corp	ANDA	Current
49999-983	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-983	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-983	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0858	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-0858	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-1086	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-1086	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-1347	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-1347	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-3516	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-3516	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50436-9887	Amoxicillin	Amoxicillin	Unit Dose Services	ANDA	Current
53217-249	Amoxicillin	Amoxicillin	Aidarex Pharmaceuticals LLC	ANDA	Current
59115-043	Amoxicillin	Amoxicillin	Hikma Pharmaceutical	ANDA	Current
59115-045	Amoxicillin	Amoxicillin	Hikma Pharmaceutical	ANDA	Current
68071-1675	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1675	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1789	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1789	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4796	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4796	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7323	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7323	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7323	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7323	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7323	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9018	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9018	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9018	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9018	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9018	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-422	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
71205-422	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
72189-385	Amoxil	Amoxicillin Oral Susp	DirectRx	ANDA	Current