Application 065119

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	200MG/5ML	No	No
002	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	400MG/5ML	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
A065119-001	AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04
A065119-002	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065119-001	AB
A065119-002	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	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065119-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2002-12-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065119-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2002-12-04	`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	A065119-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065119-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065119-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065119-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065119-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065119-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065119-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065119-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065119-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065119-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065119-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065119-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065119-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065119-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065119-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065119-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065119-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065119-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065119-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065119-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065119-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065119-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065119-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065119-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065119-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065119-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065119-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065119-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065119-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065119-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065119-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065119-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065119-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065119-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065119-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065119-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065119-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065119-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065119-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065119-002	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 · 5 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): 065119 application number: ANDA065119
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	8dfbaa75-87ba-4a6b-a2db-176441a842af	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065119 application number: ANDA065119
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	c84082fc-ea07-4e73-99c5-8356b957a1c5	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065119 application number: ANDA065119
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065119 application number: ANDA065119 ndc (product): 0093-4160 ndc (product): 0093-4161
Amoxicillin	AMOXICILLIN	Proficient Rx LP	45a872b8-07b1-44fe-8b57-cc572d480e2e	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065119 application number: ANDA065119 ndc (product): 71205-177

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-4160	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4160	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4160	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4160	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA,	ANDA	Current
0093-4161	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4161	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4161	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4161	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA,	ANDA	Current
50090-4078	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-4078	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
68071-5148	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5148	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-177	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
71205-177	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18329	SUPPL	2014-02-06