Application 211869

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOSULFAN BLUE	ISOSULFAN BLUE	INJECTABLE;INJECTION	1%	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
A211869-001	ISOSULFAN BLUE	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS			2022-09-08

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION		2022-09-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211869-001	ISOSULFAN BLUE	1%	INJECTABLE / INJECTION	AP	2022-09-08	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211869-001	ISOSULFAN BLUE	50MG/5ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		2022-09-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A211869-001	AP	1	`f41ea6bd6efb…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosulfan Blue	ISOSULFAN BLUE	Devatis, Inc.	aa6260da-0acd-4552-a215-07df8da1031c	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Isosulfan Blue generic name: ISOSULFAN BLUE
Isosulfan Blue	ISOSULFAN BLUE	Somerset Therapeutics, LLC	a4c7400a-ff36-4a76-aa84-7f91e303f937	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Isosulfan Blue generic name: ISOSULFAN BLUE
Isosulfan blue	ISOSULFAN BLUE	Novadoz Pharmaceuticals LLC	4b7e84ee-f3ba-4b80-86d3-f4debe6a2eca	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Isosulfan blue generic name: ISOSULFAN BLUE
Isosulfan Blue	ISOSULFAN BLUE	Eugia US LLC	42f2d62a-c7f2-4706-87bc-64f3e72d63a9	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: Isosulfan Blue generic name: ISOSULFAN BLUE
Isosulfan Blue	ISOSULFAN BLUE	Mylan Institutional LLC	0391e544-3633-48df-9f3a-ed16183125b1	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Isosulfan Blue generic name: ISOSULFAN BLUE
Isosulfan Blue	ISOSULFAN BLUE	Mylan Institutional LLC	1878964e-5220-48c8-a872-dcadbc451aff	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Isosulfan Blue generic name: ISOSULFAN BLUE
Isosulfan Blue	ISOSULFAN BLUE	Eugia US LLC	61b48ff8-7ace-4ab7-9f58-f250e2830d16	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Isosulfan Blue generic name: ISOSULFAN BLUE
Isosulfan Blue	ISOSULFAN BLUE	Meitheal Pharmaceuticals Inc.	d36ae5af-6351-497a-9151-82bcb2c62fa0	2021-10-12	Warnings, Adverse reactions	Name fallback brand name: Isosulfan Blue generic name: ISOSULFAN BLUE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.