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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206831

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NDA 206831 describes ISOSULFAN BLUE, which is a drug marketed by Am Regent, Eugia Pharma, Fresenius Kabi Usa, Meitheal, MSN, Mylan Institutional, Saba Ilay Sanayi, and Somerset Theraps Llc, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the ISOSULFAN BLUE profile page.

The generic ingredient in ISOSULFAN BLUE is isosulfan blue. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.

Summary for 206831

Tradename:	ISOSULFAN BLUE
Applicant:	Eugia Pharma
Ingredient:	isosulfan blue
Patents:	0

Suppliers and Packaging for NDA: 206831

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSULFAN BLUE	isosulfan blue	SOLUTION;SUBCUTANEOUS	206831	ANDA	Eugia US LLC	55150-240	55150-240-06	6 VIAL in 1 CARTON (55150-240-06) / 5 mL in 1 VIAL
ISOSULFAN BLUE	isosulfan blue	SOLUTION;SUBCUTANEOUS	206831	ANDA	Eugia US LLC	55150-240	55150-240-05	6 VIAL in 1 CARTON (55150-240-05) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Feb 2, 2016	TE:		RLD:	No

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