Application 206778

Type: ANDA
Sponsor: GLAND PHARMA 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 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
A206778-001	ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP		2018-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206778-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206778-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206778-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206778-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206778-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206778-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206778-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206778-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206778-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206778-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206778-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206778-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206778-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206778-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206778-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206778-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206778-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206778-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206778-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206778-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206778-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206778-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206778-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206778-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206778-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206778-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206778-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206778-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206778-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206778-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206778-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206778-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206778-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206778-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206778-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206778-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206778-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206778-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206778-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206778-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206778-001	AP	1	`e64feba35796…`

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
Adenosine	ADENOSINE	Sagent Pharmaceuticals	546642f2-662f-46cf-9d82-5bb3bdcc7677	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778
Adenosine	ADENOSINE	ProPharma Distribution	364a4c53-0705-7969-e063-6294a90a1717	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778
Adenosine	ADENOSINE	REMEDYREPACK INC.	9508caf5-0e3a-4d32-909d-bff7ea40ec30	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778
Adenosine	ADENOSINE	Medical Purchasing Solutions, LLC	296af833-5724-3e23-e063-6394a90a6251	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778
Adenosine	ADENOSINE	Gland Pharma Limited	1b701a86-3c4e-4c13-bf9e-aa9e73774c20	2018-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778 ndc (product): 68083-156 ndc (product): 68083-157

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-156	Adenosine	Adenosine	Gland Pharma Limited	ANDA	Current
68083-157	Adenosine	Adenosine	Gland Pharma Limited	ANDA	Current