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 4 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	0ce05282-995c-461e-b807-facb1fcbb405	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
AMOXICILLIN	AMOXICILLIN	Chartwell RX, LLC	9ce26893-c7a1-47e9-98f9-f5d998cac418	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Chartwell RX, LLC	1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Chartwell RX, LLC	5002cce4-0abc-4446-888c-47396549d4da	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Chartwell Governmental & Specialty RX, LLC	f9062321-ffb3-42e8-8f98-453cd30f5282	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	QPharma, Inc.	7f40b439-d826-4a19-b184-702e9bd5a883	2025-12-19	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin 500 mg	AMOXICILLIN	Health Department, Oklahoma State	f049551b-4708-eb13-e053-2a95a90afd1f	2025-12-13		Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	ASCLEMED USA INC.	08100595-e6de-4a8a-a177-a94f849bbe9f	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	32b224c2-1354-4b58-b082-b93330e6962b	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	QPharma, Inc.	2700df91-c5ef-4931-9ad7-a3c1c146ccac	2025-12-09	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	QPharma Inc	2772a745-1276-405b-b229-95edf5534b2a	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4528f48d-5bda-b307-e063-6294a90a294c	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8e6f9df1-0754-69e4-e053-2a95a90acc49	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	071086f5-e4ed-b1d9-e063-6294a90ad304	2025-11-13	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	bbaeb509-ad04-4668-a1db-4358038893f2	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	039d2677-b04f-436c-e063-6294a90ac519	2025-10-20	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	d0938df9-9065-47eb-9eae-0722ed1411a1	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	987786a1-d748-4b42-abb5-62a2f38ef195	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	98e9274c-c02e-44d9-8cc5-17536ef03a77	2025-10-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	b397d4be-d2ef-419a-98ac-844069c99d56	2025-10-08	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