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 6 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	9d56f34f-c025-4e97-8f5e-4d93f1ab0055	2025-04-08	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	4b15c5b4-460c-449f-9e48-99870b382826	2025-04-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	577d8a00-c538-4089-b788-01b4b92d22f2	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	54c1d2a4-fe96-6efb-e054-00144ff88e88	2025-03-31	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	992d7829-34d1-4c88-8a5c-1a92d001d194	2025-03-24	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	3d6cf1b3-f1dc-4eab-e054-00144ff88e88	2025-03-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	American Health Packaging	ecb439f7-434a-4e4c-b899-943d83346f09	2025-03-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	cf707c13-3b40-079c-e053-2995a90a2176	2025-02-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	80a04b8a-110e-0aea-e053-2a91aa0ad057	2025-02-06	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4f1c940c-9f17-4289-e054-00144ff88e88	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	05b9b595-05d9-469f-82a3-c2bc94c50be2	2025-01-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Redpharm Drug	fc61c9f5-b0f8-3ff8-e053-6394a90adeb7	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxil	AMOXICILLIN ORAL SUSP	DirectRx	ec7dd735-dc92-3d29-e053-2a95a90af549	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Amoxil
Amoxicillin	AMOXICILLIN	Direct_Rx	f98c49a3-e6bb-7fc7-e053-6394a90a9062	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
AMOXICILLIN	AMOXICILLIN	DirectRx	cedde8f5-aadd-53de-e053-2995a90aab16	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	6d7143e3-6a82-3613-e053-2a91aa0a8f65	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	5b2a2e62-6fd2-4ab1-b936-8702e68233fa	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	c84082fc-ea07-4e73-99c5-8356b957a1c5	2025-01-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Northwind Pharmaceuticals, LLC	26114563-c719-46da-b976-3e4271533f28	2025-01-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Advanced Rx Pharmacy of Tennessee, LLC	f4c36acc-828d-323b-e053-2a95a90a4d1c	2024-12-31	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