Application 078076

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADENOSINE	ADENOSINE	INJECTABLE;INJECTION	3MG/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
A078076-001	ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078076-001	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	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078076-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	RS	2008-10-31	`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	A078076-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078076-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078076-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078076-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078076-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078076-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078076-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078076-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078076-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078076-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078076-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078076-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078076-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078076-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078076-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078076-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078076-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078076-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078076-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078076-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078076-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078076-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078076-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078076-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078076-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078076-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078076-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078076-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078076-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078076-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078076-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078076-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078076-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078076-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078076-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078076-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078076-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078076-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078076-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078076-001	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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adenosine	ADENOSINE	Sagent Pharmaceuticals	546642f2-662f-46cf-9d82-5bb3bdcc7677	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
adenosine	ADENOSINE	ProPharma Distribution	48d72391-b3d4-bd97-e063-6294a90a9d6f	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: adenosine generic name: ADENOSINE
Adenosine	ADENOSINE	ProPharma Distribution	364a4c53-0705-7969-e063-6294a90a1717	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
ADENOSINE	ADENOSINE INJECTION, SOLUTION	Henry Schein, Inc.	d28ff4f3-baf4-4640-ae00-f0eb065417be	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: ADENOSINE
Adenosine	ADENOSINE	REMEDYREPACK INC.	9508caf5-0e3a-4d32-909d-bff7ea40ec30	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
Adenosine	ADENOSINE	Meitheal Pharmaceuticals Inc.	b6851256-6cef-4f23-8129-19bb64380cd5	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
Adenosine	ADENOSINE	NorthStar Rx LLC	504b4b38-fb6c-4a59-b04f-73aa7b1cbfd9	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
Adenosine	ADENOSINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	df9bed83-6c82-4294-9442-5e7464c3aab1	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
Adenosine	ADENOSINE	Medical Purchasing Solutions, LLC	296af833-5724-3e23-e063-6394a90a6251	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
adenosine	ADENOSINE	Sagent Pharmaceuticals	5a55b45d-9cee-4c0c-9e44-021dbf70a018	2024-12-04	Warnings, Adverse reactions	Name fallback brand name: adenosine generic name: ADENOSINE
Tissen ICM 10	ADENOSINE	Dalim Tissen	a2f648e2-0f8e-4635-9169-3185e8fbeb92	2024-11-25	Warnings	Name fallback generic name: ADENOSINE
Tissen NF 10	ADENOSINE	Dalim Tissen	0c71d3f0-949d-4c00-8758-4ae7c9fd11ed	2024-11-25	Warnings	Name fallback generic name: ADENOSINE
ADENOSINE	ADENOSINE	HF Acquisition Co LLC, DBA HealthFirst	1809fc7e-f5d8-18d8-e063-6394a90a7713	2024-05-09	Warnings, Adverse reactions	Name fallback brand name: ADENOSINE generic name: ADENOSINE
ADENOSINE	ADENOSINE	HF Acquisition Co LLC, DBA HealthFirst	996fc80e-b680-31f1-e053-2995a90aa0f1	2023-12-15	Warnings, Adverse reactions	Name fallback brand name: ADENOSINE generic name: ADENOSINE
Adenosine	ADENOSINE	Eugia US LLC	61d9b8f6-f93f-46ee-bec2-db8d46999792	2023-09-05	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
Reorganic Feminine wash	ADENOSINE	LAON COMMERCE co ltd	ffb36cf5-dbef-7638-e053-6394a90a5a95	2023-07-04	Warnings	Name fallback generic name: ADENOSINE
ADENOSINE	ADENOSINE	HF Acquisition Co LLC, DBA HealthFirst	fecdce1e-4233-f44c-e053-6294a90a714f	2023-06-26	Warnings, Adverse reactions	Name fallback brand name: ADENOSINE generic name: ADENOSINE
ReOrganic Womans Inner Care Essence Gel	ADENOSINE	LAON COMMERCE co ltd	fc7ec752-c676-93b8-e053-6294a90a4402	2023-05-25	Warnings	Name fallback generic name: ADENOSINE
adenosine	ADENOSINE	Medical Purchasing Solutions, LLC	a2a2fef9-d305-40ba-e053-2a95a90a0c54	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: adenosine generic name: ADENOSINE
ADENOSINE	ADENOSINE	HF Acquisition Co LLC, DBA HealthFirst	fa6eb0f8-7c41-2e17-e053-6294a90ac8ca	2023-04-28	Warnings, Adverse reactions	Name fallback brand name: ADENOSINE generic name: ADENOSINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9809	Adenosine	Adenosine	Henry Schein, Inc.	ANDA	Current
0404-9809	Adenosine	Adenosine	Henry Schein, Inc.	ANDA	Current
17478-542	Adenosine	Adenosine	Akorn, Inc.	ANDA	Current
17478-542	Adenosine	Adenosine	Akorn	ANDA	Current
17478-542	Adenosine	Adenosine	Akorn	ANDA	Current
17478-542	Adenosine	Adenosine	Akorn	ANDA	Current
17478-542	Adenosine	Adenosine	Akorn, Inc.	ANDA	Current
17478-542	Adenosine	Adenosine	Akorn, Inc.	ANDA	Current
17478-542	Adenosine	Adenosine	Akorn, Inc.	ANDA	Current
17478-953	Adenosine	Adenosine	Akorn, Inc.	ANDA	Current
17478-953	Adenosine	Adenosine	Akorn	ANDA	Current
17478-953	Adenosine	Adenosine	Akorn	ANDA	Current
17478-953	Adenosine	Adenosine	Akorn, Inc.	ANDA	Current
17478-953	Adenosine	Adenosine	Akorn, Inc.	ANDA	Current
50090-1548	Adenosine	Adenosine	A-S Medication Solutions	ANDA	Current
51662-1201	Adenosine Injection, 6mg/2mL (3mg/mL) Vial	Adenosine Injection, 6mg/2mL (3mg/mL) Vial	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1201	Adenosine Injection, 6mg/2mL (3mg/mL) Vial	Adenosine Injection, 6mg/2mL (3mg/mL) Vial	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1201	Adenosine Injection, 6mg/2mL (3mg/mL) Vial	Adenosine Injection, 6mg/2mL (3mg/mL) Vial	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1201	Adenosine Injection, 6mg/2mL (3mg/mL) Vial	Adenosine Injection, 6mg/2mL (3mg/mL) Vial	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
52584-026	Adenosine	Adenosine	General Injectables & Vaccines, Inc	ANDA	Current
52584-026	Adenosine	Adenosine	General Injectables & Vaccines, Inc	ANDA	Current
52584-026	Adenosine	Adenosine	General Injectables & Vaccines, Inc	ANDA	Current
52584-026	Adenosine	Adenosine	General Injectables & Vaccines, Inc	ANDA	Current
55154-1279	Adenosine	adenosine	Cardinal Health	ANDA	Current
71872-7035	Adenosine	Adenosine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7035	Adenosine	Adenosine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7099	Adenosine	Adenosine	Medical Purchasing Solutions, LLC	ANDA	Current