Application 064013

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	TABLET, CHEWABLE;ORAL	250MG	No	Yes
002	AMOXICILLIN	AMOXICILLIN	TABLET, CHEWABLE;ORAL	125MG	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
A064013-001	AMOXICILLIN	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22
A064013-002	AMOXICILLIN	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11

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	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	AB	RS	1992-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL	AB		1995-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	AB	RS	1992-12-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL	AB		1995-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	AB	RS	1992-12-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL	AB		1995-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	AB	RS	1992-12-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL	AB		1995-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	AB	RS	1992-12-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL	AB		1995-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A064013-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064013-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064013-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A064013-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064013-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A064013-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064013-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A064013-002	AB	1	`c0c555d07b60…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	452eb254-028a-4e02-9cb0-85483a4abaf5	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	26e257d5-5b98-3795-e063-6394a90a05bc	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	98e9274c-c02e-44d9-8cc5-17536ef03a77	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013 ndc (product): 55289-182
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013 ndc (product): 43063-341
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	3d6cf1b3-f1dc-4eab-e054-00144ff88e88	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013 ndc (product): 66267-022
Amoxicillin	AMOXICILLIN	Proficient Rx LP	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013 ndc (product): 63187-343
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8c3dd74c-872a-1ba1-e053-2a95a90a7cb3	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013 ndc (product): 66267-871
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013 ndc (product): 0093-2268 ndc (product): 0093-2267

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 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2267	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2267	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2267	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2267	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2268	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2268	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2268	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2268	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
10544-165	Amoxicillin	Amoxicillin	Blenheim Pharmacal, Inc.	ANDA	Current
21695-418	Amoxicillin	Amoxicillin	Rebel Distributors Corp.	ANDA	Current
43063-341	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-341	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-341	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-341	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0455	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-0455	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
55289-182	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-182	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-182	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-182	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-182	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-182	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-182	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55700-332	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-343	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
63187-343	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
63187-343	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current
63629-1759	Amoxicillin	Amoxicillin	Bryant Ranch Prepack	ANDA	Current
63629-4263	Amoxicillin	Amoxicillin	Bryant Ranch Prepack	ANDA	Current
66267-022	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-022	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-871	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-871	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70934-140	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-140	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-140	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-140	Amoxicillin	Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current