Application 079029

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

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
A079029-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16
A079029-002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06
A079029-003	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079029-001	AB
A079029-002	AB
A079029-003	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 · 92 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	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	A079029-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079029-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079029-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079029-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079029-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079029-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079029-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079029-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079029-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079029-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079029-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079029-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079029-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Safecor Health LLC	f49d011f-5ca6-4f75-ba16-2099fe42f5aa	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079029 application number: ANDA079029
Amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Zydus Lifesciences Limited	3e8db251-e3c5-4fba-be9a-6044a92f0beb	2024-11-25		Exact identifier application applno (ANDA): 079029 application number: ANDA079029 ndc (product): 65841-631
amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	b41cbcb5-9c5d-4e45-a4f2-952df5f22c00	2023-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079029 application number: ANDA079029 ndc (product): 68382-227

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8213	Amiodarone hydrochloride	Amiodarone hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8213	Amiodarone hydrochloride	Amiodarone hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6556	Amiodarone hydrochloride	Amiodarone hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6556	Amiodarone hydrochloride	Amiodarone hydrochloride	Major Pharmaceuticals	ANDA	Current
21695-796	Amiodarone hydrochloride	Amiodarone hydrochloride	Rebel Distributors Corp	ANDA	Current
50090-2308	Amiodarone hydrochloride	Amiodarone hydrochloride	A-S Medication Solutions	ANDA	Current
53808-1066	Amiodarone hydrochloride	Amiodarone hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
55154-4996	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-4996	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-4996	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-7890	Amiodarone hydrochloride	Amiodarone hydrochloride	Cardinal Health	ANDA	Current
55154-7890	Amiodarone hydrochloride	Amiodarone hydrochloride	Cardinal Health	ANDA	Current
63629-7300	Amiodarone hydrochloride	Amiodarone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7300	Amiodarone hydrochloride	Amiodarone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7300	Amiodarone hydrochloride	Amiodarone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63739-051	Amiodarone hydrochloride	Amiodarone hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-051	Amiodarone hydrochloride	Amiodarone hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-051	Amiodarone hydrochloride	Amiodarone hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
65084-477	Amiodarone hydrochloride	Amiodarone hydrochloride	McKesson Corporation dba RX Pak	ANDA	Current
65084-477	Amiodarone hydrochloride	Amiodarone hydrochloride	McKesson Corporation dba RX Pak	ANDA	Current
65841-631	Amiodarone hydrochloride	Amiodarone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-631	Amiodarone hydrochloride	Amiodarone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-631	Amiodarone hydrochloride	Amiodarone hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-631	Amiodarone hydrochloride	Amiodarone hydrochloride	Cadila Healthcare Limited	ANDA	Current
68084-371	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	American Health Packaging	ANDA	Current
68084-371	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	American Health Packaging	ANDA	Current
68084-371	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	American Health Packaging	ANDA	Current
68382-227	Amiodarone hydrochloride	Amiodarone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-227	Amiodarone hydrochloride	Amiodarone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-227	Amiodarone hydrochloride	Amiodarone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-1571	Amiodarone hydrochloride	Amiodarone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1571	Amiodarone hydrochloride	Amiodarone hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23927	ORIG	2008-11-13