Application 050542

Type: NDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXIL	AMOXICILLIN	TABLET, CHEWABLE;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	AMOXIL	AMOXICILLIN	TABLET, CHEWABLE;ORAL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N050542-001	AMOXIL	AMOXICILLIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, Approved before 1982
N050542-002	AMOXIL	AMOXICILLIN	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050542-001	AMOXIL	250MG	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050542-002	AMOXIL	125MG	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050542-001	AMOXIL	250MG	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050542-002	AMOXIL	125MG	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050542-001	AMOXIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050542-002	AMOXIL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`

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 9 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	6e9bf369-2f96-c7ae-e053-2a91aa0a715f	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	7524da98-b0a5-3db8-e053-2a91aa0a6ff1	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	234d0dfc-cb24-413f-b798-129c73eb848e	2024-06-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	7b182161-128e-430c-98b2-592c242ba711	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	260a3a79-9dd6-4c4b-82ec-f8050346e886	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	aee851cf-428e-4d29-a281-078fe00c56b0	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	9925773d-8ea1-4193-91e3-52cc1ce5ca67	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	14a5f8c2-fdaf-4ad4-982b-c5aa128e242d	2024-05-06	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	7db086c6-a56b-4848-9eec-abaaff9f5b6f	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	d5ecb620-5267-4dcf-be81-64c7766516f5	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	a2a5bb34-671b-499c-b8b4-c40fb51af09a	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	3d8a700b-b23b-459a-a19a-213dd39b6a3a	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	efc66d77-1733-41e1-9aed-7c10a4b4ba96	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	1dc5cc5a-59ba-4bc9-b581-cb7b70ce2652	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	322feb95-8bd4-440a-bda2-29ee19b11234	2024-04-15	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	4d0f063a-d896-4757-8f22-9614e2ad71d4	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	73219f24-6eac-4472-b2a7-cad36936c185	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	26202694-cf20-4b08-90cc-70a3d30cbb0f	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78387	SUPPL	2024-05-03
78359	SUPPL	2024-05-02
72561	SUPPL	2022-11-04
72553	SUPPL	2022-11-03
30069	SUPPL	2015-12-08
17865	SUPPL	2015-12-08
38972	SUPPL	2015-09-29
30068	SUPPL	2015-09-28
38971	SUPPL	2011-11-21
30067	SUPPL	2011-11-21
30066	SUPPL	2011-11-21
17864	SUPPL	2011-11-21
17863	SUPPL	2011-11-21
7801	SUPPL	2011-11-21
7799	SUPPL	2008-06-13
17862	SUPPL	2008-06-12
7800	SUPPL	2008-04-02
38970	SUPPL	2008-04-01
22160	SUPPL	2004-09-09
22159	SUPPL	2004-09-09
30065	SUPPL	2004-07-21
30063	SUPPL	2004-05-27
7798	SUPPL	2003-12-22
30064	SUPPL	2003-06-08
42649	SUPPL	1998-02-27
42648	SUPPL	1998-02-27
22158	SUPPL	1998-02-27