Application 077234

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

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 42.

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
A077234-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2008-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077234-001	AP

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 · 42 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	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A077234-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077234-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077234-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077234-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077234-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077234-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077234-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077234-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077234-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077234-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077234-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077234-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077234-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077234-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077234-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077234-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077234-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077234-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077234-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077234-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077234-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077234-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077234-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077234-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077234-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077234-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077234-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077234-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077234-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077234-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077234-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077234-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077234-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077234-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077234-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077234-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077234-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077234-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077234-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077234-001	AP	1	`e64feba35796…`

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	REMEDYREPACK INC.	e9151c1b-b70c-477b-868a-fffdc5c51830	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234 ndc (product): 70518-1231
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	Henry Schein, Inc.	0c9ee15a-5741-4aaa-8d80-c7bd2e45822e	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	51772745-9ea9-42cd-97e6-7266f41ae3ca	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234 ndc (product): 0143-9875
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7639dfe4-933c-2916-e053-2a91aa0a3fe7	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234 ndc (product): 51662-1205
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	66700f8b-3f76-3749-e053-2a91aa0adfdb	2023-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234 ndc (product): 71872-7000

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9875	Amiodarone Hydrochloride	Amiodarone Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9875	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
51662-1205	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1205	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1205	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1205	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-063	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
52584-063	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
70518-1231	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1231	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1231	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1231	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71872-7000	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7000	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44346	ORIG	2008-02-28