Application 204742

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	TABLET;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204742-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2016-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204742-001	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 2 · 42 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	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A204742-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204742-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204742-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204742-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204742-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204742-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204742-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204742-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204742-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204742-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204742-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204742-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204742-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204742-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204742-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204742-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204742-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204742-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204742-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204742-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204742-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204742-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204742-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204742-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204742-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204742-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204742-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204742-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204742-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204742-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204742-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204742-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204742-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204742-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204742-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204742-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204742-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204742-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204742-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204742-001	AB	1	`e64feba35796…`

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
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	51a88e8e-da02-4b97-9e7e-442fbffd908d	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742 ndc (product): 70518-1939
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Cardinal Health 107, LLC	0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742 ndc (product): 55154-8185
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Aurobindo Pharma Limited	7ae393d1-7469-432a-9f21-f5ebab1207d1	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742 ndc (product): 65862-732
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	American Health Packaging	d912a75a-ddac-4e7b-b5c4-321d4252ec05	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742 ndc (product): 60687-437
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	d42293e9-07fa-41b4-a08b-2e388f5b1e13	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742 ndc (product): 0615-8258
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	A-S Medication Solutions	bfd14110-4bf8-4fbe-a888-7b23fea6ffaa	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742 ndc (product): 50090-3015

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8258	Amiodarone Hydrochloride	Amiodarone Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8258	Amiodarone Hydrochloride	Amiodarone Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
50090-3015	Amiodarone Hydrochloride	Amiodarone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3015	Amiodarone Hydrochloride	Amiodarone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3015	Amiodarone Hydrochloride	Amiodarone Hydrochloride	A-S Medication Solutions	ANDA	Current
55154-8185	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Cardinal Health	ANDA	Current
55154-8185	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-8185	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Cardinal Health	ANDA	Current
55154-8185	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Cardinal Health	ANDA	Current
60687-437	Amiodarone Hydrochloride	Amiodarone Hydrochloride	American Health Packaging	ANDA	Current
60687-437	Amiodarone Hydrochloride	Amiodarone Hydrochloride	American Health Packaging	ANDA	Current
60687-437	Amiodarone Hydrochloride	Amiodarone Hydrochloride	American Health Packaging	ANDA	Current
60687-437	Amiodarone Hydrochloride	Amiodarone Hydrochloride	American Health Packaging	ANDA	Current
65862-732	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-732	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-732	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-732	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
70518-1939	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1939	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1939	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1939	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1939	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-280	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-280	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-280	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-280	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1297	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1297	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current