Application 204030

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	125MG/5ML	No	No
002	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	250MG/5ML	No	No

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
A204030-001	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2014-09-15
A204030-002	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB		2014-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204030-001	AB
A204030-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`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	A204030-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204030-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204030-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204030-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204030-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204030-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204030-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204030-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204030-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204030-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204030-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204030-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204030-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204030-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204030-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204030-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204030-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204030-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204030-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204030-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204030-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204030-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204030-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204030-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204030-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204030-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204030-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204030-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204030-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204030-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204030-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204030-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204030-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204030-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204030-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204030-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204030-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204030-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204030-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204030-002	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	c19b533a-907a-6350-e053-2a95a90a1244	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030 ndc (product): 68071-2397
Amoxicillin	AMOXICILLIN	Proficient Rx LP	c8e5ad7d-09b7-41d9-8cb0-467b3e8df74f	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	234d0dfc-cb24-413f-b798-129c73eb848e	2024-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030 ndc (product): 65862-706 ndc (product): 65862-707
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	14a5f8c2-fdaf-4ad4-982b-c5aa128e242d	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030 ndc (product): 50090-6319
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	7db086c6-a56b-4848-9eec-abaaff9f5b6f	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	a2a5bb34-671b-499c-b8b4-c40fb51af09a	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	efc66d77-1733-41e1-9aed-7c10a4b4ba96	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6319	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
65862-706	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-706	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-706	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-706	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-706	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-706	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-707	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-707	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-707	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-707	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-707	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
65862-707	Amoxicillin	Amoxicillin	Aurobindo Pharma Limited	ANDA	Current
68071-2397	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2875	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current