Application 076217

Type: ANDA
Sponsor: MYLAN INSTITUTIONAL

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	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076217-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076217-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076217-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076217-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076217-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076217-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076217-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076217-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076217-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076217-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076217-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076217-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076217-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076217-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076217-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076217-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076217-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076217-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076217-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076217-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076217-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076217-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076217-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076217-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076217-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076217-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076217-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076217-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076217-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076217-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076217-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076217-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076217-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076217-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076217-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076217-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076217-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076217-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076217-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076217-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076217-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076217-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076217-001	AP	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 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	ProPharma Distribution	364ab45e-b525-f310-e063-6394a90a4421	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	8d088060-70b5-e796-e053-2995a90a0969	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217 ndc (product): 51662-1358
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	8969aad3-0219-e67f-e053-2995a90aac5a	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217 ndc (product): 71872-7163
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Mylan Institutional LLC	f0b3b743-9f62-4b02-ace5-c8d93637ecad	2022-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Mylan Institutional LLC	fcc8658c-761a-443f-8c32-1499d86028ec	2020-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076217 application number: ANDA076217 ndc (product): 67457-153

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9815	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Henry Schein, Inc	ANDA	Current
0404-9815	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Henry Schein, Inc	ANDA	Current
0404-9815	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Henry Schein, Inc	ANDA	Current
0404-9815	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Henry Schein, Inc	ANDA	Current
51662-1358	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1358	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1358	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-153	Amiodarone Hydrochloride	Amiodarone Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-153	Amiodarone Hydrochloride	Amiodarone Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-153	Amiodarone Hydrochloride	Amiodarone Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-153	Amiodarone Hydrochloride	Amiodarone Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-153	Amiodarone Hydrochloride	Amiodarone Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
67457-153	Amiodarone Hydrochloride	amiodarone hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-153	Amiodarone Hydrochloride	amiodarone hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-153	Amiodarone Hydrochloride	amiodarone hydrochloride	Mylan Institutional LLC	ANDA	Current
71872-7163	Amiodarone Hydrochloride	amiodarone hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23808	ORIG	2005-07-28