Last Updated: November 8, 2026

Details for New Drug Application (NDA): 210294

NDA 210294 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.

Summary for 210294

Tradename:	ISOSULFAN BLUE
Applicant:	Am Regent
Ingredient:	isosulfan blue
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	May 17, 2023	TE:	AP	RLD:	No

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