Application 062058

Type: ANDA
Sponsor: BELCHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	CAPSULE;ORAL	250MG	No	No
002	AMOXICILLIN	AMOXICILLIN	CAPSULE;ORAL	500MG	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
A062058-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982
A062058-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062058-001	AB
A062058-002	AB

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	Product TE source text	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A062058-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062058-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062058-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062058-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062058-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062058-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062058-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062058-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062058-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062058-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062058-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062058-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062058-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062058-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062058-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062058-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062058-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062058-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062058-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062058-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062058-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062058-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062058-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062058-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062058-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062058-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062058-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062058-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062058-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062058-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062058-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062058-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062058-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062058-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062058-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062058-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062058-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062058-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062058-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062058-002	AB	1	`4b0b4de00fa7…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Chartwell RX, LLC	5002cce4-0abc-4446-888c-47396549d4da	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062058 application number: ANDA062058
Amoxicillin	AMOXICILLIN	Chartwell Governmental & Specialty RX, LLC	f9062321-ffb3-42e8-8f98-453cd30f5282	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062058 application number: ANDA062058 ndc (product): 68999-825

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-096	Amoxicillin	Amoxicillin	Blenheim Pharmacal, Inc.	ANDA	Current
15749-820	Amoxicillin	Amoxicillin	American Antibiotics,Inc	ANDA	Current
15749-825	Amoxicillin	Amoxicillin	American Antibiotics,Inc	ANDA	Current
42582-213	Amoxicillin	Amoxicillin	Bi-Coastal Pharma International LLC	ANDA	Current
42582-214	Amoxicillin	Amoxicillin	Bi-Coastal Pharma International LLC	ANDA	Current
51655-159	Amoxicillan	Amoxicillan	Northwind Pharmaceuticals,LLC	ANDA	Current
55695-001	Amoxicillin	Amoxicillin	Department of State Health Services, Pharmacy Branch	ANDA	Current
63187-044	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
63187-044	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
64205-104	Amoxicillin	Amoxicillin	ReadyMeds	ANDA	Current
67296-1320	Amoxicillin	Amoxicillin	RedPharm Drug, Inc.	ANDA	Current
67296-1320	Amoxicillin	Amoxicillin	RedPharm Drug, Inc.	ANDA	Current
68999-825	Amoxicillin	Amoxicillin	Chartwell Governmental & Specialty RX, LLC	ANDA	Current
68999-825	Amoxicillin	Amoxicillin	Chartwell Governmental & Specialty RX, LLC	ANDA	Current
70518-1099	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
70934-084	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-084	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-084	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current