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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211869

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NDA 211869 describes ISOSULFAN BLUE, which is a drug marketed by Am Regent, Beloteca, Eugia Pharma, Fresenius Kabi Usa, Meitheal, MSN, Mylan Institutional, and Somerset Theraps Llc, and is included in eight NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.

Summary for 211869

Tradename:	ISOSULFAN BLUE
Applicant:	Fresenius Kabi Usa
Ingredient:	isosulfan blue
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Sep 8, 2022	TE:		RLD:	No

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