Application 075315

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	TABLET;ORAL	200MG	No	Yes
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075315-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23
A075315-002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30

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	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL			1998-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL			2000-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB		2000-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB		2000-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB		2000-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB		2000-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075315-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075315-002	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB		2000-06-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075315-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075315-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075315-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075315-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075315-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075315-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075315-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075315-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075315-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075315-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075315-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075315-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075315-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075315-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075315-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075315-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075315-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075315-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075315-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075315-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075315-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075315-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075315-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075315-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075315-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075315-002	AB	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A075315-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075315-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075315-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075315-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075315-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075315-002	AB	1	`cb3db0bc1861…`

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 3 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	81a15062-ba1e-37c0-e053-2991aa0af945	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	8969aad3-0219-e67f-e053-2995a90aac5a	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	66700f8b-3f76-3749-e053-2a91aa0adfdb	2023-04-18	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	b41cbcb5-9c5d-4e45-a4f2-952df5f22c00	2023-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: amiodarone hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	a20d0c03-cfda-49d1-88c9-be1bf295bc6c	2023-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Mylan Institutional LLC	f0b3b743-9f62-4b02-ace5-c8d93637ecad	2022-03-15	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	AuroMedics Pharma LLC	6cd870d7-6381-421a-89bc-bce5c9518219	2021-12-08	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Gland Pharma Limited	1f00c333-9667-4ebc-8849-009a3779c0c9	2021-08-26	Warnings, Adverse reactions	Name fallback brand name: Amiodarone hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Mylan Institutional LLC	fcc8658c-761a-443f-8c32-1499d86028ec	2020-07-15	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0144	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Eon Labs, Inc.	ANDA	Current
0245-0145	Pacerone	Amiodarone Hydrochloride	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0145	Pacerone	Amiodarone Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0615-4545	Amiodarone Hydrochloride	Amiodarone Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-4545	Amiodarone Hydrochloride	Amiodarone Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
63739-387	Amiodarone Hydrochloride	Amiodarone Hydrochloride	McKesson Corporation	ANDA	Current
63739-387	Amiodarone Hydrochloride	Amiodarone Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44254	ORIG	2005-07-28
42978	ORIG	2003-08-04
30847	SUPPL	2000-06-30
8613	SUPPL	2000-06-30
30848	SUPPL	2000-04-12
8614	SUPPL	2000-04-12
8612	ORIG	1998-12-23