Application 202313

Type: ANDA
Sponsor: EMCURE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADENOSINE	ADENOSINE	SOLUTION;INTRAVENOUS	60MG/20ML (3MG/ML)	No	No
002	ADENOSINE	ADENOSINE	SOLUTION;INTRAVENOUS	90MG/30ML (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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202313-001	ADENOSINE	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP		2014-09-15
A202313-002	ADENOSINE	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP		2014-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202313-001	AP
A202313-002	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 3 · 82 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	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202313-001	ADENOSINE	60MG/20ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202313-002	ADENOSINE	90MG/30ML (3MG/ML)	SOLUTION / INTRAVENOUS	AP	2014-09-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A202313-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202313-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202313-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202313-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202313-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202313-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202313-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202313-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202313-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202313-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202313-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202313-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202313-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202313-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202313-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202313-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202313-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202313-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202313-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202313-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202313-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202313-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202313-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202313-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202313-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202313-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202313-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202313-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202313-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202313-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202313-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202313-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202313-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202313-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202313-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202313-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202313-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202313-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202313-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202313-002	AP	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adenosine	ADENOSINE	NorthStar Rx LLC	504b4b38-fb6c-4a59-b04f-73aa7b1cbfd9	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202313 application number: ANDA202313 ndc (product): 16714-556 ndc (product): 16714-997
Adenosine	ADENOSINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	df9bed83-6c82-4294-9442-5e7464c3aab1	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202313 application number: ANDA202313 ndc (product): 23155-258

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-556	Adenosine	Adenosine	NorthStar Rx LLC	ANDA	Current
16714-997	Adenosine	Adenosine	NorthStar Rx LLC	ANDA	Current
23155-258	Adenosine	Adenosine	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-258	Adenosine	Adenosine	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-258	Adenosine	Adenosine	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-259	Adenosine	Adenosine	Heritage Pharmaceuticals Inc.	ANDA	Current