Application 040811

Type: ANDA
Sponsor: DIAGNOSTIC GREEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOCYANINE GREEN	INDOCYANINE GREEN	INJECTABLE;INJECTION	25MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040811-001	INDOCYANINE GREEN	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040811-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040811-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040811-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040811-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040811-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040811-001	AP	1	`6a471c1ec25d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040811-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040811-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040811-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040811-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040811-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040811-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040811-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040811-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040811-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040811-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040811-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040811-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040811-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040811-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040811-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040811-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040811-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040811-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040811-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040811-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040811-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040811-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indocyanine Green	INDOCYANINE GREEN AND WATER	Renew Pharmaceuticals Limited	a6f24787-c243-445a-9c55-7c7479b292d9	2025-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040811 application number: ANDA040811 ndc (product): 70100-424
Indocyanine Green	INDOCYANINE GREEN AND WATER	Olympus America, Inc.	91c206e8-fab9-4bf3-afcf-304eddf0d54e	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040811 application number: ANDA040811 ndc (product): 73624-424

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17238-424	Indocyanine Green	Indocyanine Green and Water	HUB Pharmaceuticals LLC	ANDA	Current
17238-424	Indocyanine Green	Indocyanine Green and Water	HUB Pharmaceuticals LLC	ANDA	Current
17238-424	Indocyanine Green	Indocyanine Green and Water	HUB Pharmaceuticals LLC	ANDA	Current
17238-424	Indocyanine Green	Indocyanine Green and Water	HUB Pharmaceuticals LLC	ANDA	Current
17238-424	Indocyanine Green	Indocyanine Green and Water	HUB Pharmaceuticals LLC	ANDA	Current
17238-424	Indocyanine Green	Indocyanine Green and Water	HUB Pharmaceuticals LLC	ANDA	Current
49673-424	Indocyanine green	Indocyanine green	Novadaq Technologies Inc.	ANDA	Current
66259-424	Indocyanine green	Indocyanine green	Novadaq Technologies Inc.	ANDA	Current
70100-424	Indocyanine Green	Indocyanine Green and Water	Renew Pharmaceuticals Limited	ANDA	Current
70100-424	Indocyanine Green	Indocyanine Green and Water	Diagnostic Green GmbH	ANDA	Current
70100-424	Indocyanine Green	Indocyanine Green and Water	Diagnostic Green GmbH	ANDA	Current
70100-424	Indocyanine Green	Indocyanine Green and Water	Renew Pharmaceuticals Limited	ANDA	Current
70100-424	Indocyanine Green	Indocyanine Green and Water	Diagnostic Green GmbH	ANDA	Current
70599-424	ICG	Indocyanine Green and Water	KARL STORZ Endoscopy-America, Inc.	ANDA	Current
70599-424	ICG	Indocyanine Green and Water	KARL STORZ Endoscopy-America, Inc.	ANDA	Current
73624-424	Indocyanine Green	Indocyanine Green and Water	Olympus America, Inc.	ANDA	Current
75874-424	Indocyanine green	Indocyanine green	Novadaq Technologies Inc.	ANDA	Current
75874-820	Indocyanine green	Indocyanine green	Novadaq Technologies Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7680	ORIG	2007-11-26