Application 062884

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	250MG	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
A062884-001	AMOXICILLIN	AMOXICILLIN	250MG	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	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1988-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1988-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1988-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1988-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062884-001	AMOXICILLIN	250MG	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	A062884-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A062884-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062884-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062884-001	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 8 of 11 · 218 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5780c9e4-5e22-270c-e053-2a91aa0a36ba	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Rising Pharma Holdings, Inc.	554239db-69fe-405a-910a-d9f9e3f8b6ed	2024-08-06	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	c8e5ad7d-09b7-41d9-8cb0-467b3e8df74f	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8f8b1fe6-23cb-2105-e053-2a95a90aeede	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Rising Pharma Holdings, Inc.	bb7733f8-6aad-4273-84a0-ef472630203f	2024-07-07	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	7ee6b6b6-ae5b-2e39-e053-2991aa0a2377	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	830bb8fb-3743-463a-9317-3f83e3e105ac	2024-06-26	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	997650f9-7eff-64de-e053-2995a90a617b	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	97a657a3-8238-f5f1-e053-2a95a90a7a7a	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8c3ba9cf-9a28-3965-e053-2a95a90a38ce	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8dba39df-5df8-31aa-e053-2a95a90adae1	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8398f2c9-37ca-9b59-e053-2991aa0a2c11	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8995ac88-a094-2d16-e053-2a95a90a9a26	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8af9b9ee-8a64-53f5-e053-2a95a90a62a4	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8c3dd74c-872a-1ba1-e053-2a95a90a7cb3	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	3cacd754-73f4-496e-a529-9ca39fa6692d	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	76f315c4-acbc-76c1-e053-2a91aa0aebcd	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	76ba0f8d-4d1c-a5ff-e053-2a91aa0a7555	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Amoxicillin generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	6e9bf369-2f96-c7ae-e053-2a91aa0a715f	2024-06-10	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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-7100	Amoxicillin	Amoxicillin	Liberty Pharmaceuticals, Inc.	ANDA	Current
61919-016	AMOXICILLIN	AMOXICILLIN	DIRECT RX	ANDA	Current
63187-043	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
63187-043	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current