Application 213236

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REGADENOSON	REGADENOSON	SOLUTION;INTRAVENOUS	0.4MG/5ML (0.08MG/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
A213236-001	REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213236-001	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.

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	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213236-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213236-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213236-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213236-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213236-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213236-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213236-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213236-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213236-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213236-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213236-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213236-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213236-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213236-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213236-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213236-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213236-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213236-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213236-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213236-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213236-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213236-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213236-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213236-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213236-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213236-001	AP	1	`3bdfa0b2c4d7…`
2022-10-28 04:53 UTC	2022-10	A213236-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213236-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213236-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213236-001	AP	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Regadenoson	REGADENOSON	Indies Pharma Jamaica Limited	5095ab40-8503-46db-9b08-6a36f05fb5d9	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Hospira, Inc.	0e3f080d-b1fb-47ed-8cd3-90a4206fa704	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Apotex Corp.	af131207-097f-3901-e711-fba004944076	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Kanchan Healthcare Inc	b183399d-b8dc-4924-90cd-a1c2247742f3	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Apotex Corp.	88909dc6-502a-61b1-b8e1-22a42da65847	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Marlex Pharmaceuticals, Inc.	843bfba9-47de-4d76-843a-997bb4564f6e	2025-02-02	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
regadenoson	REGADENOSON	Baxter Healthcare Corporation	a81d66a7-b714-439e-ad7b-c7caf9d6f3b8	2024-09-25	Warnings, Adverse reactions	Name fallback brand name: regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Hikma Pharmaceuticals USA Inc.	9e48b407-1ce3-461d-b48e-de183802de25	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
regadenoson	REGADENOSON	Eugia US LLC	b553eb2d-0c3f-444e-ad4c-282328683110	2023-12-18	Warnings, Adverse reactions	Name fallback brand name: regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	International Medication Systems, Limited	288c76cc-ff3e-47ea-ae02-be566bd3e093	2023-04-20	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Dr. Reddy's Laboratories Inc.	03ef6420-8190-a404-f7f6-def1864a77de	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Gland Pharma Limited	5e4109f0-4875-4f8e-b70d-4055b3a785a3	2022-07-15	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
Regadenoson	REGADENOSON	Meitheal Pharmaceuticals Inc.	a550b451-fb30-4c1c-a60e-6e40fba20c88	2022-04-15	Warnings, Adverse reactions	Name fallback brand name: Regadenoson generic name: REGADENOSON
LEXISCAN	REGADENOSON	Astellas Pharma US, Inc.	057289f4-2e18-4c1e-bed4-6c1858e2ef16	2018-12-21	Warnings, Adverse reactions	Name fallback generic name: REGADENOSON