Last Updated: August 9, 2026

Details for New Drug Application (NDA): 210714

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NDA 210714 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 six 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. Six suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.

Summary for 210714

Tradename:	ISOSULFAN BLUE
Applicant:	Saba Ilay Sanayi
Ingredient:	isosulfan blue
Patents:	0

Suppliers and Packaging for NDA: 210714

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSULFAN BLUE	isosulfan blue	SOLUTION;SUBCUTANEOUS	210714	ANDA	Devatis, Inc.	73043-093	73043-093-06	6 VIAL, GLASS in 1 CARTON (73043-093-06) / 5 mL in 1 VIAL, GLASS (73043-093-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Jan 16, 2019	TE:	AP	RLD:	No

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