Application 050761

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	200MG	No	No
002	AMOXIL	AMOXICILLIN	TABLET, CHEWABLE;ORAL	400MG	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
N050761-001	AMOXIL	AMOXICILLIN	200MG	TABLET, CHEWABLE / ORAL			1999-04-15
N050761-002	AMOXIL	AMOXICILLIN	400MG	TABLET, CHEWABLE / ORAL			1999-04-15

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`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
78362	SUPPL	2024-05-02
78350	SUPPL	2024-05-02
72566	SUPPL	2022-11-04
72564	SUPPL	2022-11-04
30501	SUPPL	2015-12-08
18212	SUPPL	2015-12-08
18211	SUPPL	2015-09-29
8242	SUPPL	2015-09-28
18210	SUPPL	2011-11-21
18209	SUPPL	2011-11-21
18208	SUPPL	2011-11-21
8241	SUPPL	2011-11-21
8240	SUPPL	2011-11-21
8239	SUPPL	2011-11-21
30499	SUPPL	2008-06-13
39300	SUPPL	2008-06-12
30500	SUPPL	2008-04-02
18207	SUPPL	2008-04-01
8238	SUPPL	2006-01-30
18206	SUPPL	2006-01-27
42726	ORIG	2005-08-02
42727	SUPPL	2004-09-09
8237	SUPPL	2004-07-21
39299	ORIG	2004-05-27
8234	ORIG	2004-05-27
8236	SUPPL	2003-12-22
8235	SUPPL	2003-06-08