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 3 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Coupler LLC	5020950a-b248-a463-e063-6294a90ae57f	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	American Health Packaging	d339ea0f-8797-460f-a3b7-b8455c250366	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Sportpharm LLC	9bb2856b-feef-4063-befc-2dd917502898	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	c19b533a-907a-6350-e053-2a95a90a1244	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	afef7c71-2d19-41ed-9213-b32ccc1bf1d3	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	4b23e6f5-9287-4c01-b795-b8c538833039	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	c0e333d9-164d-4196-b5f5-929993d1c3c2	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Phamraceuticals Inc.	47424822-14a1-48e0-a62d-df34fe685726	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	8dfbaa75-87ba-4a6b-a2db-176441a842af	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	d6a33b28-f520-4a4c-b553-0ebd00558345	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	4fb7837e-964c-4d38-a3a5-b384b1bd6e08	2026-03-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	bd46de4c-4571-ba9a-e053-2a95a90a792d	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	f1eee459-9021-b26e-e053-2995a90a7291	2026-02-18	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	8bce45db-dea7-4090-9d64-8b11b08d963e	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	800f5fac-f2af-358f-e053-2a91aa0ad6a6	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Sportpharm LLC	d55dd9d9-e901-47b6-b496-5f2749726a2e	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	bb95fd06-f200-4de3-bfae-84d642d8e0f3	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	6a3f7e6c-fec2-41da-a070-00a02e64c920	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals, Inc.	88e76bdd-39f2-48c4-91ca-609511afd382	2026-01-26	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