Application 021594

Type: NDA
Sponsor: INTL MEDICATION SYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021594-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION			2004-02-04

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021594-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	2004-02-04	`f41ea6bd6efb…`

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 3 · 49 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	4c149392-a4f0-4e2d-a13f-2b94810005de	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Redpharm Drug	57f7f2ea-4ca9-4ada-e063-6294a90a492b	2026-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	51a88e8e-da02-4b97-9e7e-442fbffd908d	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Safecor Health LLC	f49d011f-5ca6-4f75-ba16-2099fe42f5aa	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: amiodarone hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	f3e631c5-1204-419c-8dbe-fa9b37a77f97	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	f4532f12-3b7a-42ab-9a6c-36fd2a3f192c	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Major Pharmaceuticals	b8bf4aa2-abea-403d-a6d9-395caf5f87f0	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Dr. Reddy's Labratories Inc.	95cef33b-c0e6-b17c-7cbb-f5c066872705	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Cardinal Health 107, LLC	0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	337c5695-e3f8-41c6-a088-a492d5c60215	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Cardinal Health 107, LLC	7bdc2236-3a1a-4210-a9fb-38f860227aa7	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Major Pharmaceuticals	352ed423-fc16-47bb-8e25-98e1c20f9991	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	7ccd3733-c3af-4a11-8500-0f99194c1472	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Aurobindo Pharma Limited	7ae393d1-7469-432a-9f21-f5ebab1207d1	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	e9151c1b-b70c-477b-868a-fffdc5c51830	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Zhejiang Poly Pharm. Co., Ltd.	0a28ae25-7cc4-4ac0-a2ba-7820fb93e25c	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	AvPAK	924c9359-ebc4-62a7-e053-2a95a90a4327	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	8377eb89-0d62-48c5-90e7-e96d545a4642	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
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	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	ProPharma Distribution	364ab45e-b525-f310-e063-6394a90a4421	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Amiodarone Hydrochloride generic name: AMIODARONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23670	ORIG	2005-07-28
21753	ORIG	2004-05-06
28214	ORIG	2004-02-27