Application 213446

Type: ANDA
Sponsor: UNICHEM LABS LTD

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

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
A213446-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2020-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213446-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213446-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213446-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213446-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213446-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213446-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213446-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213446-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213446-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213446-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213446-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213446-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213446-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213446-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213446-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213446-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213446-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213446-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213446-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213446-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213446-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213446-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213446-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213446-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213446-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213446-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213446-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213446-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213446-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213446-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213446-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213446-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213446-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213446-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213446-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213446-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213446-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213446-001	AB	1	`a50c72e98297…`

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.	4c149392-a4f0-4e2d-a13f-2b94810005de	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446 ndc (product): 70518-3246
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Redpharm Drug	57f7f2ea-4ca9-4ada-e063-6294a90a492b	2026-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	8377eb89-0d62-48c5-90e7-e96d545a4642	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446 ndc (product): 71335-1942
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	A-S Medication Solutions	c536e0ad-2758-4022-8242-f5e9b6aca1e2	2023-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446 ndc (product): 50090-5766
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	a20d0c03-cfda-49d1-88c9-be1bf295bc6c	2023-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446 ndc (product): 29300-359

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-359	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
50090-5766	Amiodarone Hydrochloride	Amiodarone Hydrochloride	A-S Medication Solutions	ANDA	Current
70518-3246	Amiodarone Hydrochloride	Amiodarone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1942	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1942	Amiodarone Hydrochloride	Amiodarone Hydrochloride	Bryant Ranch Prepack	ANDA	Current