Application 050754

Type: NDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXIL	AMOXICILLIN	TABLET;ORAL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	AMOXIL	AMOXICILLIN	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N050754-001	AMOXIL	AMOXICILLIN	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-07-10
N050754-002	AMOXIL	AMOXICILLIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-07-10

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050754-001	AMOXIL	875MG	TABLET / ORAL	RLD	1998-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050754-002	AMOXIL	500MG	TABLET / ORAL	RLD	1998-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050754-001	AMOXIL	875MG	TABLET / ORAL	RLD	1998-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050754-002	AMOXIL	500MG	TABLET / ORAL	RLD	1998-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1998-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1998-07-10	`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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-4543	AMOXICILLIN	amoxicillin	Unit Dose Services	NDA	Current
61919-017	AMOXICILLIN	AMOXICILLIN	Direct Rx	NDA	Current
63187-013	AMOXICILLIN	amoxicillin	Proficient Rx LP	NDA	Current
63187-013	AMOXICILLIN	amoxicillin	Proficient Rx LP	NDA	Current
64205-219	AMOXICILLIN	amoxicillin	ReadyMeds	NDA	Current
64205-224	AMOXICILLIN	amoxicillin	ReadyMeds	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78360	SUPPL	2024-05-02
78348	SUPPL	2024-05-01
72562	SUPPL	2022-11-04
72554	SUPPL	2022-11-03
39258	SUPPL	2015-12-08
8195	SUPPL	2015-12-08
39257	SUPPL	2015-09-29
30454	SUPPL	2015-09-28
39256	SUPPL	2011-11-21
30453	SUPPL	2011-11-21
18182	SUPPL	2011-11-21
18181	SUPPL	2011-11-21
8194	SUPPL	2011-11-21
8193	SUPPL	2011-11-21
8191	SUPPL	2008-06-13
18180	SUPPL	2008-06-12
8192	SUPPL	2008-04-02
39255	SUPPL	2008-04-01
42717	SUPPL	2004-09-09
42716	SUPPL	2004-09-09
30452	SUPPL	2004-07-21
22220	ORIG	2004-05-27
8188	SUPPL	2004-05-27
8190	SUPPL	2003-12-22
8189	SUPPL	2003-06-08
30451	ORIG	1998-07-10