Application 075424

Type: ANDA
Sponsor: TARO

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
002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	TABLET;ORAL	100MG	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
A075424-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30
A075424-002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075424-001	AB
A075424-002	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	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`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	A075424-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075424-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075424-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075424-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075424-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075424-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075424-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075424-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075424-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075424-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075424-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075424-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075424-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075424-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075424-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075424-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075424-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075424-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075424-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075424-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075424-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075424-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075424-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075424-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075424-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075424-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075424-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075424-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075424-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075424-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075424-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075424-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075424-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075424-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075424-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075424-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075424-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075424-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075424-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075424-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	f3e631c5-1204-419c-8dbe-fa9b37a77f97	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075424 application number: ANDA075424 ndc (product): 71335-0881
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Cardinal Health 107, LLC	7bdc2236-3a1a-4210-a9fb-38f860227aa7	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075424 application number: ANDA075424 ndc (product): 55154-3365
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Major Pharmaceuticals	352ed423-fc16-47bb-8e25-98e1c20f9991	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075424 application number: ANDA075424 ndc (product): 0904-6993
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	7ccd3733-c3af-4a11-8500-0f99194c1472	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075424 application number: ANDA075424 ndc (product): 51672-4055 ndc (product): 51672-4025

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6993	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6993	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Major Pharmaceuticals	ANDA	Current
42291-118	Amiodarone Hydrochloride	Amiodarone Hydrochloride	AvKARE, Inc.	ANDA	Current
50090-3496	Amiodarone Hydrochloride	Amiodarone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3496	Amiodarone Hydrochloride	Amiodarone Hydrochloride	A-S Medication Solutions	ANDA	Current
51672-4025	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4025	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4025	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4025	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4055	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4055	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4055	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4055	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55154-3365	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-3365	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Cardinal Health	ANDA	Current
55154-3365	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Cardinal Health	ANDA	Current
71335-0881	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0881	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0881	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44256	ORIG	2005-07-28
8666	ORIG	2001-03-30