Application 062881

Type: ANDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062881-001	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL			1988-02-25

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1988-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1988-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1988-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1988-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062881-001	AMOXICILLIN	500MG	CAPSULE / ORAL		1988-02-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A062881-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A062881-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062881-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062881-001	AB	1	`ea99ee380514…`

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 10 of 11 · 218 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Proficient Rx LP	6a9cfa97-3715-4b75-a1e3-932a34a942d4	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	c8591c2a-92ef-4432-b19a-bb46063047ee	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Rising Pharma Holdings, Inc.	bbe590a0-4196-4885-b679-cc1833af567f	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	116f655e-e32f-5030-e063-6394a90a64e5	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	077f4a65-3cfb-4cb1-99f2-e27ffc5939c0	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	7e3a4517-1934-4e03-b96b-4ad65ab076c5	2024-01-23	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
AMOXICILLIN	AMOXICILLIN	DIRECT RX	0173e9de-a995-4386-bb65-8fc2bbf347f9	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: AMOXICILLIN generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	66404ced-5ef4-4a31-9276-8c6f86add61c	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	fcdaba34-373f-4d4e-8203-76f02e3bb00a	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	00fbd46e-05fd-4f8a-9f59-a7a4d01c8e54	2023-12-18	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	cef5b1ae-8454-4e7a-8830-dd5d601c1d21	2023-12-09	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	ca2886d0-7be7-4d41-bad5-df3ad44e0e7e	2023-12-09	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	4eee2b38-ca84-421d-87e1-031bc5a3f3a7	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	8bac30bb-1dbc-41de-ad50-0a1883f96198	2023-11-17	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	156ef8e9-b6e4-4512-865f-7139c90c8f9b	2023-09-10	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	2c395111-c9c1-483e-a542-58b935ede689	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	bfd67724-fb22-4eac-8ebd-555614c16329	2023-06-17	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	c5d39ce2-8ae4-4bba-893f-a713afba1893	2023-04-17	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51655-157	Amoxicillan	Amoxicillan	Northwind Pharmaceuticals	ANDA	Current