Application 078686

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADENOSINE	ADENOSINE	INJECTABLE;INJECTION	3MG/ML	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
A078686-001	ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP		2009-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078686-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`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	A078686-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078686-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078686-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078686-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078686-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078686-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078686-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078686-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078686-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078686-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078686-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078686-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078686-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078686-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078686-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078686-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078686-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078686-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078686-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078686-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078686-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078686-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078686-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078686-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078686-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078686-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078686-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078686-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078686-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078686-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078686-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078686-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078686-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078686-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078686-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078686-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078686-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078686-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078686-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078686-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
adenosine	ADENOSINE	Medical Purchasing Solutions, LLC	a2a2fef9-d305-40ba-e053-2a95a90a0c54	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078686 application number: ANDA078686 ndc (product): 71872-7209
ADENOSINE	ADENOSINE	HF Acquisition Co LLC, DBA HealthFirst	fa6eb0f8-7c41-2e17-e053-6294a90ac8ca	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078686 application number: ANDA078686
adenosine	ADENOSINE	Mylan Institutional LLC	c1c149fe-9095-4b2a-a21f-7af3212e0254	2022-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078686 application number: ANDA078686 ndc (product): 72078-033
adenosine	ADENOSINE	Mylan Institutional LLC	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	2021-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078686 application number: ANDA078686 ndc (product): 67457-854 ndc (product): 67457-855

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
67457-854	adenosine	adenosine	Mylan Institutional LLC	ANDA	Current
67457-855	adenosine	adenosine	Mylan Institutional LLC	ANDA	Current
70518-2778	adenosine	adenosine	REMEDYREPACK INC.	ANDA	Current
71872-7209	adenosine	adenosine	Medical Purchasing Solutions, LLC	ANDA	Current
72078-033	adenosine	adenosine	Mylan Institutional LLC	ANDA	Current