Is there a generic for Isosulfan blue?

Yes. The FDA Orange Book lists 8 approved generic (ANDA) applications for Isosulfan blue, referencing the brand LYMPHAZURIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Isosulfan blue?

LYMPHAZURIN (NDA 018310, COVIDIEN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Isosulfan blue are approved?

Isosulfan blue is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Isosulfan blue

Isosulfan blue: 1 brand, 8 generics; first approved Jul 20, 2010; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 8 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

LYMPHAZURINRLD

COVIDIENNDA 018310—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	SUBCUTANEOUS	Discontinued	—

Abbreviated applications

Generic (ANDA) products (8)

ISOSULFAN BLUERS

MYLAN INSTITUTIONALANDA 09087420263 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	AP
10MG/ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	—
30MG/3ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	—

ISOSULFAN BLUE

AM REGENTANDA 2102942023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

ISOSULFAN BLUE

MSNANDA 2160902022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

ISOSULFAN BLUE

FRESENIUS KABI USAANDA 2118692022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Discontinued	—

ISOSULFAN BLUE

MEITHEALANDA 2131302021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

ISOSULFAN BLUE

SOMERSET THERAPS LLCANDA 2105582019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

ISOSULFAN BLUE

SABA ILAY SANAYIANDA 2107142019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Discontinued	—

ISOSULFAN BLUE

EUGIA PHARMAANDA 2068312016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML (10MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Jul 20, 2010

16 yr 3 mo ago

Most recent approval

Jan 28, 2026

5 mo ago

Approvals span 2010–2026 across 9 FDA applications.

Brand (NDA) 111%

Generic (ANDA) 889%

Isosulfan blue — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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