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 44.

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050761-001	AMOXIL	200MG	TABLET, CHEWABLE / ORAL	1999-04-15	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050761-002	AMOXIL	400MG	TABLET, CHEWABLE / ORAL	1999-04-15	`3a93d1ddd44b…`

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 1 of 11 · 217 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMOXICILLIN	AMOXICILLIN	REMEDYREPACK INC.	4adc198e-39d8-4b3e-bfa4-278aaf4064ae	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	b6ea2f81-aee6-4c88-b681-50eb28e80a86	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Redpharm Drug	5a79669f-52f7-e8ea-e063-6394a90a93b8	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	f37eb415-77b2-41b0-8d20-64e821e4b05d	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
AMOXICILLIN	AMOXICILLIN	Redpharm Drug	5a660370-9a81-33f9-e063-6394a90a6c62	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Sportpharm LLC	c4d4aeca-f63c-4548-a9b7-7f627e8fd45c	2026-08-29	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	82c0c5d1-df2d-4352-bd12-99f955af569e	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	3a4afd36-dffa-44a1-9d09-e93cf66053bf	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	452eb254-028a-4e02-9cb0-85483a4abaf5	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	afb4149a-0714-4a85-b9e8-2379a8e6a302	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Coupler LLC	5827b6de-6b48-d73a-e063-6394a90a4a72	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8cb987bf-d45a-c15a-e053-2995a90aad46	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Redpharm Drug	57f5652d-ee50-eb7e-e063-6394a90a7b66	2026-08-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Redpharm Drug	57e56202-950b-10f6-e063-6394a90a4912	2026-07-31	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4a402dba-c255-5db8-e054-00144ff8d46c	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	a2c91cf0-a4e4-44c0-b712-bee63dd6c22b	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	102c62ca-da20-4866-84a8-e3513824af4a	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	9618d038-e880-47f6-b8d7-bbf8ab35364d	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	bf130964-8386-4ab7-8d3b-fb0174670afc	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	18a4f555-a537-4c40-9bb2-dc3bd782fa27	2026-07-17	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