Application 061926

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	CAPSULE;ORAL	250MG	No	No
003	AMOXICILLIN	AMOXICILLIN	CAPSULE;ORAL	500MG	No	Yes

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
A061926-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982
A061926-003	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, 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
A061926-001	AB
A061926-003	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	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, 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	A061926-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A061926-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A061926-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061926-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061926-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061926-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061926-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061926-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061926-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061926-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061926-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061926-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061926-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061926-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061926-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061926-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061926-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061926-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061926-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061926-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061926-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061926-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061926-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061926-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061926-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061926-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061926-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061926-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061926-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061926-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061926-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061926-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061926-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061926-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061926-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061926-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061926-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061926-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061926-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061926-003	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	QPharma, Inc	60c788d1-6c91-4456-848a-893e649e90be	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926 ndc (product): 42708-010
Amoxicillin	AMOXICILLIN	Redpharm Drug	3d0025b4-b7bb-69db-e063-6294a90a0e70	2025-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	80a04b8a-110e-0aea-e053-2a91aa0ad057	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926 ndc (product): 68071-4741
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8c3ba9cf-9a28-3965-e053-2a95a90a38ce	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926 ndc (product): 68071-4944
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926 ndc (product): 0093-3107 ndc (product): 0093-3109
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	be1d1a44-7ef3-445d-9970-494921de4c9d	2023-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926

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 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3107	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3107	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3107	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3107	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3109	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3109	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3109	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3109	Amoxicillin	Amoxicillin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42708-010	Amoxicillin	Amoxicillin	QPharma Inc	ANDA	Current
42708-010	Amoxicillin	Amoxicillin	QPharma Inc	ANDA	Current
42708-010	Amoxicillin	Amoxicillin	QPharma Inc	ANDA	Current
50090-4320	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-4325	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
50090-4325	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
55289-019	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-019	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-019	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-019	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-019	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-020	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-020	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-020	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-020	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-020	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
61919-424	AMOXICILLIN	AMOXICILLIN	DIRECT RX	ANDA	Current
66116-821	Amoxicillin	Amoxicillin	MedVantx, Inc.	ANDA	Current
67296-0023	Amoxicillin	Amoxicillin	RedPharm Drug Inc.	ANDA	Current
68071-4741	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4741	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4741	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4741	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4741	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4944	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4971	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4971	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-5052	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3234	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current
70518-3234	Amoxicillin	Amoxicillin	REMEDYREPACK INC.	ANDA	Current