Application 065255

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065255-001	AMOXICILLIN	AMOXICILLIN	875MG	TABLET / ORAL	AB		2006-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065255-001	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 2 · 42 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	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A065255-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065255-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065255-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065255-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065255-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065255-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065255-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065255-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065255-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065255-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065255-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065255-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065255-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065255-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065255-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065255-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065255-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065255-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065255-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065255-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065255-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065255-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065255-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065255-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065255-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065255-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065255-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065255-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065255-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065255-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065255-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065255-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065255-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065255-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065255-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065255-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065255-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065255-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065255-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065255-001	AB	1	`e64feba35796…`

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	Preferred Pharmaceuticals Inc.	6a3f7e6c-fec2-41da-a070-00a02e64c920	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	b397d4be-d2ef-419a-98ac-844069c99d56	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255 ndc (product): 72789-224
Amoxicillin	AMOXICILLIN	Proficient Rx LP	577d8a00-c538-4089-b788-01b4b92d22f2	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	05b9b595-05d9-469f-82a3-c2bc94c50be2	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255 ndc (product): 43063-885
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	26469497-14c2-adb2-e063-6394a90af30a	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	85721bc3-37eb-4db6-8a40-8a1412ac953a	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255 ndc (product): 50090-5880
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	c8591c2a-92ef-4432-b19a-bb46063047ee	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255 ndc (product): 0143-9285
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	4eee2b38-ca84-421d-87e1-031bc5a3f3a7	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255 ndc (product): 50090-5863
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	23b7a1fe-4e23-44ec-bc51-5209427c88ce	2022-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255 ndc (product): 76420-138

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9285	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9285	Amoxicillin	Amoxicillin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9285	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9285	Amoxicillin	Amoxicillin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9951	Amoxicillin	Amoxicillin	West-Ward Pharmaceutical Corp	ANDA	Current
10544-434	Amoxicillin	Amoxicillin	Blenheim Pharmacal, Inc.	ANDA	Current
35356-983	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42708-011	Amoxicillin	Amoxicillin	QPharma Inc	ANDA	Current
42708-011	Amoxicillin	Amoxicillin	QPharma Inc	ANDA	Current
43063-885	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-885	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-885	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-885	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-885	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-885	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0711	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-0712	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-5863	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-5863	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-5880	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
55289-707	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, In	ANDA	Current
55700-687	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-687	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-041	AMOXIL	AMOXICILLIN	DIRECT RX	ANDA	Current
61919-041	AMOXIL	AMOXICILLIN	DIRECT RX	ANDA	Current
63187-138	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
66336-074	Amoxicillin	Amoxicillin	Dispensing Solutions, Inc.	ANDA	Current
67296-0628	Amoxicillin	Amoxicillin	RedPharm Drug Inc.	ANDA	Current
68788-0763	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1715	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
70518-1715	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
72789-224	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-138	Amoxicillin	Amoxicillin	Asclemed USA, Inc.	ANDA	Current