Application 078578

Type: ANDA
Sponsor: RUBICON

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
003	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	TABLET;ORAL	400MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078578-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06
A078578-002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26
A078578-003	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078578-001	AB
A078578-002	AB
A078578-003	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 1 of 3 · 112 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	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 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	A078578-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078578-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078578-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078578-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078578-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078578-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078578-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078578-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078578-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078578-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078578-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078578-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078578-001	AB	1	`1e350fbaab3a…`

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 · 5 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	f4532f12-3b7a-42ab-9a6c-36fd2a3f192c	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578 ndc (product): 71335-1985
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Major Pharmaceuticals	b8bf4aa2-abea-403d-a6d9-395caf5f87f0	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	337c5695-e3f8-41c6-a088-a492d5c60215	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578 ndc (product): 70518-3439
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	28cd0224-3569-4308-bd40-480bc4230503	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Advagen Pharma Limited	d911b4cf-eec4-43f8-aa64-cc60cfc901b9	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578 ndc (product): 72888-060 ndc (product): 72888-061 ndc (product): 72888-039

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-2658	Amiodarone Hydrochloride	Amiodarone Hydrochloride	APOTEX Corp	ANDA	Current
70518-3439	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3439	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1985	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1985	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72888-039	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-039	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-060	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-061	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Advagen Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44387	ORIG	2008-11-25