Application 065056

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	TABLET;ORAL	500MG	No	No
002	AMOXICILLIN	AMOXICILLIN	TABLET;ORAL	875MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065056-001	AMOXICILLIN	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18
A065056-002	AMOXICILLIN	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065056-001	AB
A065056-002	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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065056-001	AMOXICILLIN	500MG	TABLET / ORAL	AB		2000-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065056-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	RS	2000-09-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065056-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065056-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065056-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065056-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065056-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065056-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065056-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065056-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065056-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065056-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065056-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065056-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065056-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065056-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065056-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065056-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065056-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065056-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065056-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065056-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065056-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065056-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065056-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065056-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065056-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065056-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065056-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065056-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065056-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065056-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065056-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065056-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065056-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065056-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065056-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065056-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065056-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065056-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065056-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065056-002	AB	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMOXICILLIN	AMOXICILLIN	Chartwell RX, LLC	b07b5ac4-253e-4c83-91c3-3fdc46e91a0f	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065056 application number: ANDA065056
Amoxicillin	AMOXICILLIN	QPharma, Inc.	7f40b439-d826-4a19-b184-702e9bd5a883	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065056 application number: ANDA065056 ndc (product): 42708-112
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065056 application number: ANDA065056 ndc (product): 0093-2263 ndc (product): 0093-2264

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2263	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2263	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2264	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2264	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42708-112	Amoxicillin	Amoxicillin	QPharma Inc	ANDA	Current
42708-112	Amoxicillin	Amoxicillin	QPharma Inc	ANDA	Current
42708-112	Amoxicillin	Amoxicillin	QPharma Inc	ANDA	Current
50090-4929	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
70934-672	Amoxicillin	Amoxicillin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18326	SUPPL	2014-02-06
22307	ORIG	2003-07-31
8381	ORIG	2000-09-18